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Temozolomide and Sunitinib Malate in Treating Patients With Stage III or Stage IV Malignant Melanoma

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT01005472
First received: October 30, 2009
Last updated: January 27, 2014
Last verified: January 2014
  Purpose

RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving temozolomide together with sunitinib malate may kill more tumor cells.

PURPOSE: This phase I/II trial is studying the side effects and best dose of sunitinib malate when given together with temozolomide and to see how well they work in treating patients with stage III or stage IV malignant melanoma.


Condition Intervention Phase
Metastatic Melanoma
Drug: sunitinib malate
Drug: temozolomide
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I/II Study of Daily Oral Dosing With Temozolomide and Sunitinib Malate for 6 Weeks of an 8-Week Cycle in Patients With Metastatic and Unresectable Locally-Advanced Malignant Melanoma

Resource links provided by NLM:


Further study details as provided by Jonsson Comprehensive Cancer Center:

Primary Outcome Measures:
  • Maximum tolerated dose of sunitinib malate when administered concurrently with temozolomide (Phase I) [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
  • Overall safety [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Response rate as assessed by modified RECIST criteria (phase II) [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Response rate as assessed by modified RECIST criteria (Phase I) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Progression-free survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 48
Study Start Date: December 2008
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: sunitinib malate, temozolomide Drug: sunitinib malate Drug: temozolomide

Detailed Description:

OBJECTIVES:

Primary

  • Assess the maximum tolerated dose of sunitinib malate when administered concurrently with temozolomide in patients with stage IIIC or IV malignant melanoma. (Phase I)
  • Assess the overall safety of this regimen in these patients. (Phase I)
  • Determine the response rate in patients treated with this regimen. (Phase II)

Secondary

  • Determine the response rate in patients treated with this regimen. (Phase I)
  • Determine the safety and tolerability of this regimen in these patients. (Phase II)
  • Determine the progression-free survival of patients treated with this regimen.
  • Determine the overall survival of patients treated with this regimen.

OUTLINE: This is a phase I, dose-escalation study of sunitinib malate followed by a phase II study.

Patients receive oral sunitinib malate once daily and oral temozolomide once daily on days 1-42. Treatment repeats every 56 days for up to 1 year in the absence of disease progression or unacceptable toxicity.

After completion of study therapy, patients are followed up very 6 months for up to 5 years.

  Eligibility

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

Inclusion Criteria:

  • Histologically confirmed Stage IIIC unresectable cutaneous or mucosal melanoma with measureable disease or stage IV cutaneous, mucosal or ocular melanoma with measureable disease.
  • ECOG performance status of 0-2
  • age greater than or equal to 18 years
  • ANC ≥ 1,500/µL
  • Platelet count ≥ 100,000/µL
  • Hemoglobin ≥ 10.0 g/dL
  • Creatinine ≤ 2 times upper limit of normal (ULN)
  • Total bilirubin ≤ 2 times ULN
  • LDH ≤ 5 times ULN
  • AST or ALT ≤ 2.5 times ULN (≤ 5 times ULN if liver metastasis is present)
  • LVEF ≥ 50% on screening ECHO
  • women of childbearing potential must have a negative urine or serum pregnancy test upto 28 days prior to commencement of dosing.
  • Fertile patients must use effective contraception during and for ≥ 6 months after completion of study treatment
  • Willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures
  • before study entry , written informed consent must be obtained. Written informed consent must be obtained from patient prior to performing any study related procedures.

Exclusion Criteria

  • pregnant or nursing
  • any following within the past 12 months:
  • Myocardial infarction
  • Severe and/or unstable angina
  • Coronary and/or peripheral artery bypass graft
  • Symptomatic congestive heart failure
  • Cerebrovascular accident or transient ischemic attack
  • Pulmonary embolism
  • ongoing cardiac dysrhythmias ≥ grade 2, according to NCI CTCAE v3.0
  • prolonged QTc interval on baseline EKG
  • uncontrolled hypertension (i.e., blood pressure > 150/100 mm Hg despite optimal medical therapy)
  • pre-existing thyroid abnormality with thyroid function that cannot be maintained in the normal range with medication
  • any known clinically uncontrolled infectious disease, including HIV positivity or AIDS-related illness
  • severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration or may interfere with the interpretation of study results, and, in the judgment of the investigator, would make the patient inappropriate for study entry
  • prior chemotherapy for melanoma, except for chemotherapy given during isolated limb perfusion for stage IIIC disease
  • Prior adjuvant immunotherapy and/or immunotherapy for metastatic disease allowed
  • prior major surgery, radiotherapy, or immunotherapy within 4 weeks of starting therapy
  • treatment with potent CYP3A4 inhibitors 7 days before study dosing
  • treatment with potent CYP3A4 inducers 12 days before study dosing
  • concurrent treatment on another clinical trial (Concurrent participation on supportive care trials or non-treatment trials (e.g., quality-of-life trials) allowed).
  • concurrent chemotherapy, immunotherapy, biological therapy, or investigational drugs
  • concurrent drugs with dysrhythmic potential, including any of the following:
  • Terfenadine
  • Quinidine
  • Procainamide
  • Disopyramide
  • Sotalol
  • Probucol
  • Bepridil
  • Haloperidol
  • Risperidone
  • Indapamide
  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: NCT01005472

Locations
United States, California
University of California Los Angeles (UCLA)
Los Angeles, California, United States, 90095
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
Investigators
Principal Investigator: Bartosz Chmielowski, MD University of California, Los Angeles
  More Information

Additional Information:
No publications provided

Responsible Party: Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01005472     History of Changes
Obsolete Identifiers: NCT00859326
Other Study ID Numbers: CDR0000634373, P30CA016042, UCLA-0711052, SPRI-P05513, PFIZER-GA6181FZ
Study First Received: October 30, 2009
Last Updated: January 27, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Jonsson Comprehensive Cancer Center:
stage III melanoma
stage IV melanoma
recurrent melanoma
ciliary body and choroid melanoma, medium/large size
extraocular extension melanoma
iris melanoma
metastatic intraocular melanoma
recurrent intraocular melanoma

Additional relevant MeSH terms:
Melanoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Neuroectodermal Tumors
Neuroendocrine Tumors
Nevi and Melanomas
Dacarbazine
Sunitinib
Temozolomide
Alkylating Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Growth Inhibitors
Growth Substances
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014