Cabozantinib-S-Malate Compared With Temozolomide or Dacarbazine in Treating Patients With Melanoma of the Eye

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by National Cancer Institute (NCI)
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01835145
First received: April 16, 2013
Last updated: October 20, 2014
Last verified: September 2014
  Purpose

This randomized phase II trial studies how well cabozantinib-s-malate works compared with temozolomide or dacarbazine in treating patients with melanoma of the eye (ocular melanoma). Cabozantinib-s-malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as temozolomide and dacarbazine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether cabozantinib-s-malate works better than temozolomide or dacarbazine in treating patients with melanoma of the eye.


Condition Intervention Phase
Ciliary Body and Choroid Melanoma, Medium/Large Size
Ciliary Body and Choroid Melanoma, Small Size
Iris Melanoma
Metastatic Intraocular Melanoma
Recurrent Intraocular Melanoma
Stage IIIA Intraocular Melanoma
Stage IIIB Intraocular Melanoma
Stage IIIC Intraocular Melanoma
Stage IV Intraocular Melanoma
Drug: cabozantinib-s-malate
Drug: temozolomide
Drug: dacarbazine
Other: laboratory biomarker analysis
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Phase II Study Comparing the MET Inhibitor Cabozantinib to Temozolomide/Dacarbazine in Ocular Melanoma

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • PFS4 [ Time Frame: At 4 months ] [ Designated as safety issue: No ]
    A patient will be declared a PFS4 success if they are on study and progression free for at least 4 months. This study will be declared promising if a one-sided chi-squared test for a difference in PFS4 rates yields a p-value of less than 0.10.


Secondary Outcome Measures:
  • PFS [ Time Frame: Number of days from registration until disease progression (or death), assessed up to 2 years ] [ Designated as safety issue: No ]
    The distribution of PFS time will be estimated using the method of Kaplan Meier.

  • Overall survival (OS) [ Time Frame: Number of days from registration until death, assessed up to 2 years ] [ Designated as safety issue: No ]
    The distribution of OS time will be estimated using the method of Kaplan Meier.

  • Confirmed response rate as determined by the RECIST criteria (version 1.1) [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
    The confirmed response rates will be estimated by dividing the number of confirmed responders by the number of evaluable patients. 95% confidence intervals will be calculated.

  • Maximum grade for each type of adverse event, graded according to the National Cancer Institute (NCI) CTCAE version 4.0 [ Time Frame: Up to 2 years ] [ Designated as safety issue: Yes ]
    Frequency tables will be created to look for patterns.


Estimated Enrollment: 69
Study Start Date: July 2013
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I (cabozantinib-s-malate)
Patients receive cabozantinib-s-malate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Drug: cabozantinib-s-malate
Given PO
Other Names:
  • BMS-907351
  • Cometriq
  • XL184
Other: laboratory biomarker analysis
Correlative studies
Experimental: Arm II (temozolomide or dacarbazine)
Patients receive temozolomide PO daily on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. If temozolomide is not available, patients receive dacarbazine IV over 15-60 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. At the time of progression patients may cross-over to Arm I.
Drug: temozolomide
Given PO
Other Names:
  • SCH 52365
  • Temodal
  • Temodar
  • TMZ
Drug: dacarbazine
Given IV
Other Names:
  • DIC
  • DTIC
  • DTIC-Dome
Other: laboratory biomarker analysis
Correlative studies

Detailed Description:

PRIMARY OBJECTIVES:

I. Compare the progression-free survival rate at 4 months (PFS4) of patients with ocular melanoma treated with cabozantinib (cabozantinib-s-malate) or temozolomide (or dacarbazine).

SECONDARY OBJECTIVES:

I. Estimate the distribution of progression-free survival (PFS) times. II. Estimate the distribution of overall survival (OS) times. III. Estimate the confirmed response rate as determined by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria.

IV. Assess the safety of these agents by examining the toxicity profile. V. Correlate the response of mesenchymal-epithelial transition factor (MET) molecular status.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive cabozantinib-s-malate orally (PO) once daily (QD) on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive temozolomide PO daily on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. If temozolomide is not available, patients receive dacarbazine intravenously (IV) over 15-60 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. At the time of progression patients may cross-over to Arm I.

After completion of study treatment, patients are followed up every 12 weeks for 2 years.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically or cytologically confirmed uveal melanoma that is metastatic or unresectable; if histologic or cytologic confirmation of the primary is not available, confirmation of the primary diagnosis of uveal melanoma by the treating investigator can be clinically obtained, as per standard practice for uveal melanoma; pathologic confirmation of diagnosis will be performed at the participating site
  • Measurable disease defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as >= 20 mm with conventional techniques or as >= 10 mm with spiral computed tomography (CT) scan or magnetic resonance imaging (MRI)
  • Prior systemic therapies allowed, except for those treatments directed toward, or with activity against, c-Met or vascular endothelial growth factor/receptor (VEGF/R), and the chemotherapy agents temozolomide and dacarbazine; prior treatment must have been no earlier than 3 weeks prior to starting treatment with cabozantinib with exceptions noted and the following: at least 4 weeks since prior hepatic infusion or at least 2 weeks since radiation therapy
  • No cytotoxic chemotherapy including investigational cytotoxic chemotherapy or biologic agents (e.g., cytokines or antibodies) within the last 3 weeks, or nitrosoureas/mitomycin C within 6 weeks before the first dose of study treatment; at least 6 weeks must have elapsed if the last regimen included an anti-cytotoxic T-lymphocyte antigen 4 (CTLA4) antibody; patients must have experienced disease progression on their prior therapy in the opinion of the treating investigator
  • No prior radiation therapy within the last 4 weeks, except as below

    • To the thoracic cavity, abdomen, or pelvis within 12 weeks before the first dose of study treatment, or has ongoing complications, or is without complete recovery to < grade 1 toxicity
    • To bone or brain metastasis within 14 days before the first dose of study treatment
    • To any other site(s) within 28 days before the first dose of study treatment
    • Prior radiation treatment may have included no more than 3000 centigray (cGy) to fields including substantial bone marrow
  • No prior radionuclide treatment within 6 weeks of the first dose of study treatment
  • No prior treatment with a small molecule kinase inhibitor or a hormonal therapy within 14 days or 5 half-lives (whichever is longer)
  • No concomitant anti-cancer therapy within 28 days of the first dose of study treatment, including other investigational agents; palliative radiation therapy will not be allowed while on protocol
  • Eastern Cooperative Oncology Group (ECOG) performance status =< 1 (Karnofsky >= 70%)
  • A corrected QT interval calculated by the Fridericia formula (QTcF) =< 500 ms within 28 days before randomization; Note: if initial QTcF is found to be > 500 ms, two additional electrocardiograms (EKGs) separated by at least 3 minutes should be performed; if the average of these three consecutive results for QTcF is =< 500 ms, the patient meets eligibility in this regard
  • Common Terminology Criteria for Adverse Events (CTCAE) recovered to baseline or CTCAE =< grade 1 from toxicity due to all prior therapies except alopecia and other non-clinically significant adverse events (AEs)
  • No active brain metastases or epidural disease; patients with brain metastases previously treated with whole brain radiation or radiosurgery or patients with epidural disease previously treated with radiation or surgery who are asymptomatic and do not require steroid treatment for at least 2 weeks before starting study treatment are eligible; neurosurgical resection of brain metastases or brain biopsy is permitted if completed at least 12 weeks before starting study treatment; baseline brain imaging with contrast-enhanced CT or MRI scans for patients with known brain metastases is required to confirm eligibility
  • No clinically significant gastrointestinal bleeding within 24 weeks before the first dose of study treatment
  • No hemoptysis of >= 0.5 teaspoon (2.5 mL) of red blood within 12 weeks before the first dose of study treatment
  • No signs indicative of pulmonary hemorrhage within 12 weeks before the first dose of study treatment
  • No prior radiographic evidence of cavitating pulmonary lesion(s)
  • No tumor in contact with, invading or encasing any major blood vessels
  • No evidence of tumor invading the gastrointestinal (GI) tract (esophagus, stomach, small or large bowel, rectum or anus), or any evidence of endotracheal or endobronchial tumor within 28 days before the first dose of treatment
  • The patient may not have uncontrolled, significant intercurrent or recent illness including, but not limited to, the following conditions:

    • Cardiovascular disorders including:

      • Congestive heart failure (CHF): New York Heart Association (NYHA) class III (moderate) or class IV (severe) at the time of screening
      • Concurrent uncontrolled hypertension defined as sustained blood pressure (BP) > 140 mmHg systolic, or > 90 mmHg diastolic despite optimal antihypertensive treatment within 7 days of the first dose of study treatment
      • Any history of congenital long QT syndrome
      • Any of the following within 24 weeks before the first dose of study treatment:

        • Unstable angina pectoris
        • Clinically-significant cardiac arrhythmias
        • Stroke (including transient ischemic attack [TIA], or other ischemic event)
        • Myocardial infarction
        • Thromboembolic event requiring therapeutic anticoagulation (Note: patients with a venous filter [e.g. vena cava filter] are not eligible for this study)
    • Gastrointestinal disorders particularly those associated with a high risk of perforation or fistula formation including:

      • Any of the following within 28 days before the first dose of study treatment

        • Intra-abdominal tumor/metastases invading GI mucosa
        • Active peptic ulcer disease
        • Inflammatory bowel disease (including ulcerative colitis and Crohn's disease), diverticulitis, cholecystitis, symptomatic cholangitis or appendicitis
        • Malabsorption syndrome
      • Any of the following within 24 weeks before the first dose of study treatment:

        • Abdominal fistula
        • Gastrointestinal perforation
        • Intra-abdominal abscess; Note: complete resolution of an intra-abdominal abscess must be confirmed prior to initiating treatment with cabozantinib even if the abscess occurred more that 24 weeks before the first dose of study treatment
        • Bowel obstruction or gastric outlet obstruction
    • Other clinically significant disorders such as:

      • Serious non-healing wound/ulcer/bone fracture within 28 days before the first dose of study treatment
      • History of organ transplant
      • Concurrent uncompensated hypothyroidism or thyroid dysfunction within 7 days before the first dose of study treatment
      • History of major surgery as follows:

        • Major surgery in past 8 weeks of the first dose of cabozantinib if there were no wound healing complications or within 24 weeks of the first dose of cabozantinib if there were wound complications
        • Minor surgery within 4 weeks of the first dose of cabozantinib if there were no wound healing complications or within 12 weeks of the first dose of cabozantinib if there were wound complications
        • In addition, complete wound healing from prior surgery must be confirmed at least 28 days before the first dose of cabozantinib irrespective of the time from surgery
      • Active infection requiring systemic treatment within 28 days before the first dose of study treatment
  • No concomitant treatment, in therapeutic doses, with anticoagulants such as warfarin or warfarin-related agents, heparin, thrombin or factor Xa inhibitors, or antiplatelet agents (e.g., clopidogrel); low dose aspirin (=< 81 mg/day), low-dose warfarin (=< 1 mg/day), and prophylactic low molecular weight heparin (LMWH) are permitted; please note that drugs that strongly induce or inhibit cytochrome P450 family 3, subfamily A, polypeptide 4 (CYP3A4) or are associated with a risk of Torsades are not allowed; chronic concomitant treatment of CYP3A4 inducers is not allowed (e.g., dexamethasone, phenytoin, carbamazepine, rifampin, rifabutin, rifapentine, phenobarbital, and St. John's wort); as part of the enrollment/informed consent procedures, the patient will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the patient is considering a new over-the-counter medicine or herbal product; the following drugs are strong inhibitors of CYP3A4 and are not allowed during the treatment with cabozantinib:

    • Boceprevir
    • Indinavir
    • Nelfinavir
    • Lopinavir/ritonavir
    • Saquinavir
    • Telaprevir
    • Ritonavir
    • Clarithromycin
    • Conivaptan
    • Itraconazole
    • Ketoconazole
    • Mibefradil
    • Nefazodone
    • Posaconazole
    • Voriconazole
    • Telithromycin
    • Drugs with possible or conditional risk of torsades should be used with caution knowing that cabozantinib could prolong the QT interval
  • Patients who are pregnant or nursing are not eligible; women of child bearing potential must have a negative serum or urine pregnancy test within 16 days prior to registration; women of child-bearing potential include:

    • Any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or is not postmenopausal (defined as amenorrhea >= 12 consecutive months)
    • Women on hormone replacement therapy (HRT) with documented serum follicle stimulating hormone (FSH) level > 35m IU/mL
    • Women who are using oral, implanted or injectable contraceptive hormones or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy or practicing abstinence or where partner is sterile (e.g., vasectomy)
  • No history of allergic reactions attributed to compounds of similar chemical or biologic composition to cabozantinib, temozolomide and dacarbazine
  • Absolute neutrophil count >= 1,500/mcL
  • Platelets >= 100,000/mcL
  • Total bilirubin =< 1.5 × upper limit of normal (ULN)
  • Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 5.0 × institutional upper limit of normal (for patients with metastases); AST (SGOT)/ALT (SGPT) =< 2.5 × institutional upper limit of normal (for patients without metastases)
  • Serum creatinine =< 1.5 × ULN, OR calculated creatinine clearance >= 30 mL/minute (modified Cockcroft and Gault formula)
  • Hemoglobin >= 9 g/dL
  • Serum albumin >= 2.8 g/dL
  • Urine protein/creatinine ratio (UPCR) =< 1; if urine/protein creatinine (UPC) >= 1, then a 24-hour urine protein must be assessed; eligible patients must have a 24-hour urine protein value < 1 g/L
  • Thyroid-stimulating hormone (TSH) within normal limits (WNL); supplementation is acceptable to achieve a TSH WNL; in patients with abnormal TSH however free T4 and free thyroxine index (FTI) are normal and patient is clinically euthyroid, patient is eligible
  • Prothrombin time (PT)/international normalized ratio (INR) must be =< 1.2 x the laboratory ULN
  • No clinical or radiographic evidence of pancreatitis
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01835145

  Hide Study Locations
Locations
United States, Delaware
Beebe Medical Center Recruiting
Lewes, Delaware, United States, 19958
Contact: Stephen S. Grubbs    302-733-6227      
Principal Investigator: Stephen S. Grubbs         
Delaware Clinical and Laboratory Physicians PA Recruiting
Newark, Delaware, United States, 19713
Contact: Stephen S. Grubbs    302-733-6227      
Principal Investigator: Stephen S. Grubbs         
Medical Oncology Hematology Consultants PA Recruiting
Newark, Delaware, United States, 19713
Contact: Stephen S. Grubbs    302-733-6227      
Principal Investigator: Stephen S. Grubbs         
Regional Hematology and Oncology PA Recruiting
Newark, Delaware, United States, 19713
Contact: Stephen S. Grubbs    302-733-6227      
Principal Investigator: Stephen S. Grubbs         
Helen F Graham Cancer Center Recruiting
Newark, Delaware, United States, 19713
Contact: Stephen S. Grubbs    302-733-6227      
Principal Investigator: Stephen S. Grubbs         
Christiana Gynecologic Oncology LLC Recruiting
Newark, Delaware, United States, 19713
Contact: Stephen S. Grubbs    302-733-6227      
Principal Investigator: Stephen S. Grubbs         
Christiana Care Health System-Christiana Hospital Recruiting
Newark, Delaware, United States, 19718
Contact: Stephen S. Grubbs    302-733-6227      
Principal Investigator: Stephen S. Grubbs         
Beebe Health Campus Recruiting
Rehoboth Beach, Delaware, United States, 19971
Contact: Stephen S. Grubbs    302-733-6227      
Principal Investigator: Stephen S. Grubbs         
Nanticoke Memorial Hospital Recruiting
Seaford, Delaware, United States, 19973
Contact: Stephen S. Grubbs    302-733-6227      
Principal Investigator: Stephen S. Grubbs         
Christiana Care Health System-Wilmington Hospital Recruiting
Wilmington, Delaware, United States, 19801
Contact: Stephen S. Grubbs    302-733-6227      
Principal Investigator: Stephen S. Grubbs         
United States, Florida
Holy Cross Hospital Terminated
Fort Lauderdale, Florida, United States, 33308
Jupiter Medical Center Terminated
Jupiter, Florida, United States, 33458
Mount Sinai Medical Center Recruiting
Miami Beach, Florida, United States, 33140
Contact: Jose Lutzky    305-674-2625    info@msccop.com   
Principal Investigator: Jose Lutzky         
United States, Idaho
Kootenai Cancer Center Recruiting
Post Falls, Idaho, United States, 83854
Contact: Benjamin T. Marchello    800-648-6274      
Principal Investigator: Benjamin T. Marchello         
United States, Illinois
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Contact: Timothy M. Kuzel    312-695-1301    cancer@northwestern.edu   
Principal Investigator: Timothy M. Kuzel         
Hematology Oncology Associates of Illinois-Highland Park Recruiting
Highland Park, Illinois, United States, 60035
Contact: Timothy M. Kuzel    312-695-1301    cancer@northwestern.edu   
Principal Investigator: Timothy M. Kuzel         
Presence Saint Mary's Hospital Recruiting
Kankakee, Illinois, United States, 60901
Contact: Timothy M. Kuzel    312-695-1301    cancer@northwestern.edu   
Principal Investigator: Timothy M. Kuzel         
North Shore Hematology Oncology Recruiting
Libertyville, Illinois, United States, 60048
Contact: Timothy M. Kuzel    312-695-1301    cancer@northwestern.edu   
Principal Investigator: Timothy M. Kuzel         
Loyola University Medical Center Recruiting
Maywood, Illinois, United States, 60153
Contact: Joseph I. Clark    708-226-4357      
Principal Investigator: Joseph I. Clark         
Trinity Medical Center Recruiting
Moline, Illinois, United States, 61265
Contact: David M. Spector    309-779-4200      
Principal Investigator: David M. Spector         
Porubcin, Michael MD (UIA Investigator) Terminated
Moline, Illinois, United States, 61265
Garneau, Stewart C MD (UIA Investigator) Recruiting
Moline, Illinois, United States, 61265
Contact: David M. Spector    309-779-4200      
Principal Investigator: David M. Spector         
Spector, David MD (UIA Investigator) Recruiting
Moline, Illinois, United States, 61265
Contact: David M. Spector    309-779-4200      
Principal Investigator: David M. Spector         
Good Samaritan Regional Health Center Recruiting
Mount Vernon, Illinois, United States, 62864
Contact: Jay W. Carlson    800-821-7532    sherrijr@iora.org   
Principal Investigator: Jay W. Carlson         
Illinois Cancer Specialists-Niles Recruiting
Niles, Illinois, United States, 60714
Contact: Timothy M. Kuzel    312-695-1301    cancer@northwestern.edu   
Principal Investigator: Timothy M. Kuzel         
Hematology Oncology Associates of Illinois - Skokie Recruiting
Skokie, Illinois, United States, 60076
Contact: Timothy M. Kuzel    312-695-1301    cancer@northwestern.edu   
Principal Investigator: Timothy M. Kuzel         
United States, Iowa
Mary Greeley Medical Center Recruiting
Ames, Iowa, United States, 50010
Contact: Joseph J. Merchant    515-239-2621      
Principal Investigator: Joseph J. Merchant         
McFarland Clinic PC-William R Bliss Cancer Center Recruiting
Ames, Iowa, United States, 50010
Contact: Joseph J. Merchant    515-239-2621      
Principal Investigator: Joseph J. Merchant         
Constantinou, Costas L MD (UIA Investigator) Recruiting
Bettendorf, Iowa, United States, 52722
Contact: David M. Spector    309-779-4200      
Principal Investigator: David M. Spector         
McFarland Clinic PC-Boone Recruiting
Boone, Iowa, United States, 50036
Contact: Joseph J. Merchant    515-239-2621      
Principal Investigator: Joseph J. Merchant         
McFarland Clinic PC-Trinity Cancer Center Recruiting
Fort Dodge, Iowa, United States, 50501
Contact: Joseph J. Merchant    515-239-2621      
Principal Investigator: Joseph J. Merchant         
University of Iowa Hospitals and Clinics Recruiting
Iowa City, Iowa, United States, 52242
Contact: Mohammed M. Milhem    800-237-1225      
Principal Investigator: Mohammed M. Milhem         
McFarland Clinic PC-Jefferson Recruiting
Jefferson, Iowa, United States, 50129
Contact: Joseph J. Merchant    515-239-2621      
Principal Investigator: Joseph J. Merchant         
McFarland Clinic PC-Marshalltown Recruiting
Marshalltown, Iowa, United States, 50158
Contact: Joseph J. Merchant    515-239-2621      
Principal Investigator: Joseph J. Merchant         
Mercy Medical Center-Sioux City Terminated
Sioux City, Iowa, United States, 51104
Siouxland Hematology Oncology Associates Recruiting
Sioux City, Iowa, United States, 51101
Contact: Donald B. Wender    712-252-0088      
Principal Investigator: Donald B. Wender         
Saint Luke's Regional Medical Center Terminated
Sioux City, Iowa, United States, 51104
United States, Kansas
Menorah Medical Center Recruiting
Overland Park, Kansas, United States, 66209
Contact: Rakesh Gaur    913-948-5588    aroland@kccop.org   
Principal Investigator: Rakesh Gaur         
Saint Luke's South Hospital Recruiting
Overland Park, Kansas, United States, 66213
Contact: Rakesh Gaur    913-948-5588    aroland@kccop.org   
Principal Investigator: Rakesh Gaur         
Kansas City CCOP Terminated
Prairie Village, Kansas, United States, 66208
United States, Massachusetts
Massachusetts General Hospital Cancer Center Recruiting
Boston, Massachusetts, United States, 02114
Contact: Frank S. Hodi    866-790-4500      
Principal Investigator: Frank S. Hodi         
Dana-Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02115
Contact: Frank S. Hodi    866-790-4500      
Principal Investigator: Frank S. Hodi         
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Frank S. Hodi    866-790-4500      
Principal Investigator: Frank S. Hodi         
United States, Michigan
Bronson Battle Creek Recruiting
Battle Creek, Michigan, United States, 49017
Contact: Gilbert D. Padula    616-685-5225      
Principal Investigator: Gilbert D. Padula         
Green Bay Oncology - Escanaba Recruiting
Escanaba, Michigan, United States, 49431
Contact: Anthony J. Jaslowski    800-432-6049      
Principal Investigator: Anthony J. Jaslowski         
Mercy Health Saint Mary's Active, not recruiting
Grand Rapids, Michigan, United States, 49503
Grand Rapids Clinical Oncology Program Terminated
Grand Rapids, Michigan, United States, 49503
Spectrum Health at Butterworth Campus Recruiting
Grand Rapids, Michigan, United States, 49503
Contact: Gilbert D. Padula    616-685-5225      
Principal Investigator: Gilbert D. Padula         
Green Bay Oncology - Iron Mountain Recruiting
Iron Mountain, Michigan, United States, 49801
Contact: Anthony J. Jaslowski    800-432-6049      
Principal Investigator: Anthony J. Jaslowski         
Mercy Health Mercy Campus Active, not recruiting
Muskegon, Michigan, United States, 49444
Lakeland Community Hospital Recruiting
Niles, Michigan, United States, 49120
Contact: Gilbert D. Padula    616-685-5225      
Principal Investigator: Gilbert D. Padula         
Spectrum Health Reed City Hospital Recruiting
Reed City, Michigan, United States, 49677
Contact: Gilbert D. Padula    616-685-5225      
Principal Investigator: Gilbert D. Padula         
Marie Yeager Cancer Center Recruiting
Saint Joseph, Michigan, United States, 49085
Contact: Gilbert D. Padula    616-685-5225      
Principal Investigator: Gilbert D. Padula         
Lakeland Hospital Recruiting
St. Joseph, Michigan, United States, 49085
Contact: Gilbert D. Padula    616-685-5225      
Principal Investigator: Gilbert D. Padula         
Munson Medical Center Recruiting
Traverse City, Michigan, United States, 49684
Contact: Gilbert D. Padula    616-685-5225      
Principal Investigator: Gilbert D. Padula         
United States, Minnesota
Miller-Dwan Hospital Recruiting
Duluth, Minnesota, United States, 55805
Contact: Bret E. Friday    888-203-7267      
Principal Investigator: Bret E. Friday         
Essentia Health Duluth Clinic CCOP Recruiting
Duluth, Minnesota, United States, 55805
Contact: Bret E. Friday    888-203-7267      
Principal Investigator: Bret E. Friday         
Essentia Health Saint Mary's Medical Center Recruiting
Duluth, Minnesota, United States, 55805
Contact: Bret E. Friday    888-203-7267      
Principal Investigator: Bret E. Friday         
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Robert R. McWilliams    507-538-7623      
Principal Investigator: Robert R. McWilliams         
United States, Missouri
CoxHealth Cancer Center Active, not recruiting
Branson, Missouri, United States, 65616
Centerpoint Medical Center LLC Recruiting
Independence, Missouri, United States, 64057
Contact: Rakesh Gaur    913-948-5588    aroland@kccop.org   
Principal Investigator: Rakesh Gaur         
Mercy Hospital-Joplin Active, not recruiting
Joplin, Missouri, United States, 64804
Heartland Hematology and Oncology Associates Incorporated Recruiting
Kansas City, Missouri, United States, 64118
Contact: Rakesh Gaur    913-948-5588    aroland@kccop.org   
Principal Investigator: Rakesh Gaur         
Saint Luke's Hospital of Kansas City Recruiting
Kansas City, Missouri, United States, 64111
Contact: Rakesh Gaur    913-948-5588    aroland@kccop.org   
Principal Investigator: Rakesh Gaur         
Research Medical Center Recruiting
Kansas City, Missouri, United States, 64132
Contact: Rakesh Gaur    913-948-5588    aroland@kccop.org   
Principal Investigator: Rakesh Gaur         
Saint Luke's East - Lee's Summit Recruiting
Lee's Summit, Missouri, United States, 64086
Contact: Rakesh Gaur    913-948-5588    aroland@kccop.org   
Principal Investigator: Rakesh Gaur         
Liberty Radiation Oncology Center Recruiting
Liberty, Missouri, United States, 64068
Contact: Rakesh Gaur    913-948-5588    aroland@kccop.org   
Principal Investigator: Rakesh Gaur         
Saint John's Clinic-Rolla-Cancer and Hematology Active, not recruiting
Rolla, Missouri, United States, 65401
Saint Joseph Oncology Inc Terminated
Saint Joseph, Missouri, United States, 64507
Heartland Regional Medical Center Recruiting
Saint Joseph, Missouri, United States, 64506
Contact: Rakesh Gaur    913-948-5588    aroland@kccop.org   
Principal Investigator: Rakesh Gaur         
Saint John's Mercy Medical Center Active, not recruiting
Saint Louis, Missouri, United States, 63141
Saint Louis Cancer and Breast Institute-South City Active, not recruiting
Saint Louis, Missouri, United States, 63109
CoxHealth South Hospital Active, not recruiting
Springfield, Missouri, United States, 65807
Ozark Health Ventures LLC-Cancer Research for The Ozarks Springfield Terminated
Springfield, Missouri, United States, 65804
Mercy Hospital Springfield Recruiting
Springfield, Missouri, United States, 65804
Contact: Jay W. Carlson    800-821-7532    sherrijr@iora.org   
Principal Investigator: Jay W. Carlson         
United States, Montana
Billings Clinic Recruiting
Billings, Montana, United States, 59107-7000
Contact: Benjamin T. Marchello    800-648-6274      
Principal Investigator: Benjamin T. Marchello         
Saint Vincent Healthcare Recruiting
Billings, Montana, United States, 59101
Contact: Benjamin T. Marchello    800-648-6274      
Principal Investigator: Benjamin T. Marchello         
Montana Cancer Consortium CCOP Recruiting
Billings, Montana, United States, 59101
Contact: Benjamin T. Marchello    800-648-6274      
Principal Investigator: Benjamin T. Marchello         
Bozeman Deaconess Hospital Recruiting
Bozeman, Montana, United States, 59715
Contact: Benjamin T. Marchello    800-648-6274      
Principal Investigator: Benjamin T. Marchello         
Saint James Community Hospital and Cancer Treatment Center Recruiting
Butte, Montana, United States, 59701
Contact: Benjamin T. Marchello    800-648-6274      
Principal Investigator: Benjamin T. Marchello         
Benefis Healthcare- Sletten Cancer Institute Recruiting
Great Falls, Montana, United States, 59405
Contact: Benjamin T. Marchello    800-648-6274      
Principal Investigator: Benjamin T. Marchello         
Saint Peter's Community Hospital Recruiting
Helena, Montana, United States, 59601
Contact: Benjamin T. Marchello    800-648-6274      
Principal Investigator: Benjamin T. Marchello         
Kalispell Regional Medical Center Recruiting
Kalispell, Montana, United States, 59901
Contact: Benjamin T. Marchello    800-648-6274      
Principal Investigator: Benjamin T. Marchello         
Saint Patrick Hospital - Community Hospital Recruiting
Missoula, Montana, United States, 59802
Contact: Benjamin T. Marchello    800-648-6274      
Principal Investigator: Benjamin T. Marchello         
United States, Nevada
Cancer and Blood Specialists-Henderson Recruiting
Henderson, Nevada, United States, 89052
Contact: John A. Ellerton    702-384-0013      
Principal Investigator: John A. Ellerton         
Las Vegas Cancer Center-Henderson Recruiting
Henderson, Nevada, United States, 89052
Contact: John A. Ellerton    702-384-0013      
Principal Investigator: John A. Ellerton         
Comprehensive Cancer Centers of Nevada - Henderson Recruiting
Henderson, Nevada, United States, 89052
Contact: John A. Ellerton    702-384-0013      
Principal Investigator: John A. Ellerton         
Comprehensive Cancer Centers of Nevada-Southeast Henderson Recruiting
Henderson, Nevada, United States, 89074
Contact: John A. Ellerton    702-384-0013      
Principal Investigator: John A. Ellerton         
21st Century Oncology - Henderson Recruiting
Henderson, Nevada, United States, 89074
Contact: John A. Ellerton    702-384-0013      
Principal Investigator: John A. Ellerton         
Cancer and Blood Specialists-Tenaya Recruiting
Las Vegas, Nevada, United States, 89128
Contact: John A. Ellerton    702-384-0013      
Principal Investigator: John A. Ellerton         
Cancer Therapy and Integrative Medicine Recruiting
Las Vegas, Nevada, United States, 89121
Contact: John A. Ellerton    702-384-0013      
Principal Investigator: John A. Ellerton         
Comprehensive Cancer Centers of Nevada - Central Valley Recruiting
Las Vegas, Nevada, United States, 89169
Contact: John A. Ellerton    702-384-0013      
Principal Investigator: John A. Ellerton         
Comprehensive Cancer Centers of Nevada - Northwest Recruiting
Las Vegas, Nevada, United States, 89128
Contact: John A. Ellerton    702-384-0013      
Principal Investigator: John A. Ellerton         
Las Vegas Cancer Center-Medical Center Recruiting
Las Vegas, Nevada, United States, 89148-2405
Contact: John A. Ellerton    702-384-0013      
Principal Investigator: John A. Ellerton         
Cancer and Blood Specialists-Shadow Recruiting
Las Vegas, Nevada, United States, 89106
Contact: John A. Ellerton    702-384-0013      
Principal Investigator: John A. Ellerton         
21st Century Oncology - Vegas Sunrise Recruiting
Las Vegas, Nevada, United States, 89109
Contact: John A. Ellerton    702-384-0013      
Principal Investigator: John A. Ellerton         
21st Century Oncology - Vegas Tenaya Recruiting
Las Vegas, Nevada, United States, 89182
Contact: John A. Ellerton    702-384-0013      
Principal Investigator: John A. Ellerton         
Comprehensive Cancer Centers of Nevada-Summerlin Recruiting
Las Vegas, Nevada, United States, 89144
Contact: John A. Ellerton    702-384-0013      
Principal Investigator: John A. Ellerton         
University Medical Center of Southern Nevada Recruiting
Las Vegas, Nevada, United States, 89102
Contact: John A. Ellerton    702-384-0013      
Principal Investigator: John A. Ellerton         
Cancer and Blood Specialists-Fort Apache Recruiting
Las Vegas, Nevada, United States, 89148
Contact: John A. Ellerton    702-384-0013      
Principal Investigator: John A. Ellerton         
Nevada Cancer Research Foundation CCOP Recruiting
Las Vegas, Nevada, United States, 89106
Contact: John A. Ellerton    702-384-0013      
Principal Investigator: John A. Ellerton         
HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills Recruiting
Las Vegas, Nevada, United States, 89149
Contact: John A. Ellerton    702-384-0013      
Principal Investigator: John A. Ellerton         
HealthCare Partners Medical Group Oncology/Hematology-San Martin Recruiting
Las Vegas, Nevada, United States, 89113
Contact: John A. Ellerton    702-384-0013      
Principal Investigator: John A. Ellerton         
Radiation Oncology Centers of Nevada Southeast Recruiting
Las Vegas, Nevada, United States, 89119
Contact: John A. Ellerton    702-384-0013      
Principal Investigator: John A. Ellerton         
Radiation Oncology Centers of Nevada Central Recruiting
Las Vegas, Nevada, United States, 89106
Contact: John A. Ellerton    702-384-0013      
Principal Investigator: John A. Ellerton         
HealthCare Partners Medical Group Oncology/Hematology-Tenaya Recruiting
Las Vegas, Nevada, United States, 89128
Contact: John A. Ellerton    702-384-0013      
Principal Investigator: John A. Ellerton         
21st Century Oncology - Fort Apache Recruiting
Las Vegas, Nevada, United States, 89148
Contact: John A. Ellerton    702-384-0013      
Principal Investigator: John A. Ellerton         
Comprehensive Cancer Centers of Nevada Recruiting
Las Vegas, Nevada, United States, 89148
Contact: John A. Ellerton    702-384-0013      
Principal Investigator: John A. Ellerton         
HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway Recruiting
Las Vegas, Nevada, United States, 89109
Contact: John A. Ellerton    702-384-0013      
Principal Investigator: John A. Ellerton         
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Jeffrey Crawford    888-275-3853      
Principal Investigator: Jeffrey Crawford         
Kinston Medical Specialists PA Recruiting
Kinston, North Carolina, United States, 28501
Contact: Peter R. Watson    252-559-2200      
Principal Investigator: Peter R. Watson         
Wake Forest University Health Sciences Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Paul D. Savage    336-713-6771      
Principal Investigator: Paul D. Savage         
United States, Ohio
Ohio State University Medical Center Recruiting
Columbus, Ohio, United States, 43210
Contact: Thomas E. Olencki    866-627-7616    osu@emergingmed.com   
Principal Investigator: Thomas E. Olencki         
United States, Oregon
Clackamas Radiation Oncology Center Active, not recruiting
Clackamas, Oregon, United States, 97015
Providence Milwaukie Hospital Terminated
Milwaukie, Oregon, United States, 97222
Providence Newberg Medical Center Active, not recruiting
Newberg, Oregon, United States, 97132
Providence Willamette Falls Medical Center Active, not recruiting
Oregon City, Oregon, United States, 97045
Providence Saint Vincent Medical Center Active, not recruiting
Portland, Oregon, United States, 97225
Providence Portland Medical Center Active, not recruiting
Portland, Oregon, United States, 97213
Western Oncology Research Consortium Terminated
Portland, Oregon, United States, 97213
United States, South Carolina
Greenville Health System Cancer Institute-Easley Recruiting
Easley, South Carolina, United States, 29640
Contact: Jeffrey K. Giguere    864-241-6251      
Principal Investigator: Jeffrey K. Giguere         
Greenville Health System Cancer Institute-Andrews Recruiting
Greenville, South Carolina, United States, 29605
Contact: Jeffrey K. Giguere    864-241-6251      
Principal Investigator: Jeffrey K. Giguere         
Greenville Health System Cancer Institute-Butternut Recruiting
Greenville, South Carolina, United States, 29605
Contact: Jeffrey K. Giguere    864-241-6251      
Principal Investigator: Jeffrey K. Giguere         
Greenville Health System Cancer Institute-Faris Recruiting
Greenville, South Carolina, United States, 29605
Contact: Jeffrey K. Giguere    864-241-6251      
Principal Investigator: Jeffrey K. Giguere         
Greenville Health System Cancer Institute/Eastside Recruiting
Greenville, South Carolina, United States, 29615
Contact: Jeffrey K. Giguere    864-241-6251      
Principal Investigator: Jeffrey K. Giguere         
Greenville Memorial Hospital Recruiting
Greenville, South Carolina, United States, 29605
Contact: Jeffrey K. Giguere    864-241-6251      
Principal Investigator: Jeffrey K. Giguere         
Greenville Health System Cancer Institute-Greer Recruiting
Greer, South Carolina, United States, 29650
Contact: Jeffrey K. Giguere    864-241-6251      
Principal Investigator: Jeffrey K. Giguere         
Greenville Health System Cancer Institute-Seneca Recruiting
Seneca, South Carolina, United States, 29672
Contact: Jeffrey K. Giguere    864-241-6251      
Principal Investigator: Jeffrey K. Giguere         
Greenville Health System Cancer Institute-Spartanburg Recruiting
Spartanburg, South Carolina, United States, 29307
Contact: Jeffrey K. Giguere    864-241-6251      
Principal Investigator: Jeffrey K. Giguere         
United States, Texas
University of Texas Southwestern Medical Center Active, not recruiting
Dallas, Texas, United States, 75390
United States, Washington
Compass Oncology Vancouver Terminated
Vancouver, Washington, United States, 98684
PeaceHealth Southwest Medical Center Active, not recruiting
Vancouver, Washington, United States, 98664
United States, Wisconsin
Saint Vincent Hospital Recruiting
Green Bay, Wisconsin, United States, 54301
Contact: Anthony J. Jaslowski    800-432-6049      
Principal Investigator: Anthony J. Jaslowski         
Green Bay Oncology Limited at Saint Mary's Hospital Recruiting
Green Bay, Wisconsin, United States, 54303
Contact: Anthony J. Jaslowski    800-432-6049      
Principal Investigator: Anthony J. Jaslowski         
Green Bay Oncology at Saint Vincent Hospital Recruiting
Green Bay, Wisconsin, United States, 54301-3526
Contact: Anthony J. Jaslowski    800-432-6049      
Principal Investigator: Anthony J. Jaslowski         
Saint Mary's Hospital Recruiting
Green Bay, Wisconsin, United States, 54303
Contact: Anthony J. Jaslowski    800-432-6049      
Principal Investigator: Anthony J. Jaslowski         
University of Wisconsin Hospital and Clinics Recruiting
Madison, Wisconsin, United States, 53792
Contact: Mark R. Albertini    877-405-6866      
Principal Investigator: Mark R. Albertini         
Holy Family Memorial Hospital Recruiting
Manitowoc, Wisconsin, United States, 54221
Contact: Anthony J. Jaslowski    800-432-6049      
Principal Investigator: Anthony J. Jaslowski         
Bay Area Medical Center Recruiting
Marinette, Wisconsin, United States, 54143
Contact: Anthony J. Jaslowski    800-432-6049      
Principal Investigator: Anthony J. Jaslowski         
Froedtert and the Medical College of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Amy K. Harker-Murray    414-805-4380      
Principal Investigator: Amy K. Harker-Murray         
Green Bay Oncology - Oconto Falls Recruiting
Oconto Falls, Wisconsin, United States, 54154
Contact: Anthony J. Jaslowski    800-432-6049      
Principal Investigator: Anthony J. Jaslowski         
Saint Nicholas Hospital Recruiting
Sheboygan, Wisconsin, United States, 53081
Contact: Anthony J. Jaslowski    800-432-6049      
Principal Investigator: Anthony J. Jaslowski         
Green Bay Oncology - Sturgeon Bay Recruiting
Sturgeon Bay, Wisconsin, United States, 54235
Contact: Anthony J. Jaslowski    800-432-6049      
Principal Investigator: Anthony J. Jaslowski         
United States, Wyoming
Rocky Mountain Oncology Terminated
Casper, Wyoming, United States, 82609
Welch Cancer Center Recruiting
Sheridan, Wyoming, United States, 82801
Contact: Benjamin T. Marchello    800-648-6274      
Principal Investigator: Benjamin T. Marchello         
Sponsors and Collaborators
Investigators
Principal Investigator: Jason Luke Alliance for Clinical Trials in Oncology
  More Information

No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01835145     History of Changes
Other Study ID Numbers: NCI-2013-00821, NCI-2013-00821, CALGB-A091201, A091201, A091201, U10CA180821, U10CA031946
Study First Received: April 16, 2013
Last Updated: October 20, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Melanoma
Uveal Neoplasms
Eye Diseases
Eye Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Neuroectodermal Tumors
Neuroendocrine Tumors
Nevi and Melanomas
Uveal Diseases
Dacarbazine
Temozolomide
Alkylating Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014