Everolimus in Treating Patients With Stage IV Melanoma
This study has been completed.
Sponsor:
North Central Cancer Treatment Group
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00098553
First received: December 7, 2004
Last updated: June 17, 2012
Last verified: January 2007
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Purpose
RATIONALE: Drugs used in chemotherapy, such as everolimus, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Everolimus may also stop the growth of melanoma by blocking blood flow to the tumor.
PURPOSE: This phase II trial is studying how well everolimus works in treating patients with stage IV melanoma.
| Condition | Intervention | Phase |
|---|---|---|
|
Melanoma (Skin) |
Drug: everolimus |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Trial Of RAD-001 In Metastatic Malignant Melanoma |
Resource links provided by NLM:
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Proportion of patients with progression-free disease at 16 weeks [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Median overall survival [ Designated as safety issue: No ]
- Tumor response rate for 2 consecutive evaluations at least 8 weeks apart [ Designated as safety issue: No ]
- Toxicity as measured by CTCAE v. 3.0 [ Designated as safety issue: Yes ]
- Efficacy as measured by fludeoxyglucose F 18 uptake at baseline and at weeks 8 and 16 by positron-emission tomography imaging [ Designated as safety issue: No ]
- Efficacy as measured by the intensity of tissue vascular endothelial growth factor (VEGF) based on percentage of tumor cells positive for stain and the intensity of staining and microvessel density at 8 weeks and at diseae progression [ Designated as safety issue: No ]
- Efficacy as measured by serum VEGF levels at baseline, 8 weeks, and at disease progression [ Designated as safety issue: No ]
- Effect of therapy on the immune system at 8 weeks [ Designated as safety issue: No ]
| Estimated Enrollment: | 73 |
| Study Start Date: | April 2005 |
| Primary Completion Date: | July 2007 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
- Determine the median time to disease progression in patients with stage IV malignant melanoma treated with everolimus.
Secondary
- Determine the median overall survival of patients treated with this drug.
- Determine the clinical benefit rates (i.e., stable disease, partial remission, and complete response rates) in patients treated with this drug.
- Determine the toxicity profile of this drug in these patients.
- Determine changes in serum vascular endothelial growth factor levels in patients treated with this drug.
OUTLINE: This is a multicenter study.
Patients receive oral everolimus once daily for 8 weeks. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed every 2 months until disease progression and then every 4 months for up to 5 years after registration.
PROJECTED ACCRUAL: A total of 73 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
DISEASE CHARACTERISTICS:
Histologically confirmed malignant melanoma for which no known standard or potentially curative therapy exists or has been proven to extend life expectancy
- Stage IV disease
Measurable disease
- At least 1 lesion ≥ 20 mm by CT scan or MRI OR ≥ 10 mm by spiral CT scan
- No intracranial disease
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- ECOG 0-2
Life expectancy
- At least 12 weeks
Hematopoietic
- Absolute neutrophil count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- Hemoglobin ≥ 9.0 g/dL
- No bleeding diathesis
Hepatic
- AST ≤ 3 times upper limit of normal (ULN)
- Alkaline phosphatase ≤ 3 ULN
- INR ≤ 1.5
Renal
- Creatinine ≤ 1.5 times ULN
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- Willing to refrain from foods high in fat content
- No uncontrolled infection
- No immunosuppression from any cause (e.g., known HIV infection)
- No other malignancy within the past 5 years except basal cell or squamous cell skin cancer treated with local resection only
- No other severe condition that would preclude study participation or compliance
PRIOR CONCURRENT THERAPY:
Biologic therapy
- More than 4 weeks since prior immunotherapy or biologic therapy
Chemotherapy
- More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
- No prior sirolimus or its analogues for any indication
- No other concurrent chemotherapy
Endocrine therapy
- No concurrent steroids
Radiotherapy
- More than 4 weeks since prior radiotherapy to head and neck area
- More than 4 weeks since prior radiosurgery
- No prior radiotherapy to > 30% of bone marrow
- No concurrent radiotherapy
Surgery
- Not specified
Other
- At least 1 week since prior and no concurrent CYP3A4 inducers
- No concurrent warfarin
- No concurrent cytotoxic agents
- No other concurrent experimental drugs
- No other concurrent immunosuppressive therapy
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00098553
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| United States, Arizona | |
| Mayo Clinic Scottsdale | |
| Scottsdale, Arizona, United States, 85259-5499 | |
| United States, Florida | |
| Mayo Clinic - Jacksonville | |
| Jacksonville, Florida, United States, 32224 | |
| United States, Illinois | |
| Rush-Copley Cancer Care Center | |
| Aurora, Illinois, United States, 60507 | |
| Joliet Oncology-Hematology Associates, Limited - West | |
| Joliet, Illinois, United States, 60435 | |
| Moline, Illinois, United States, 61265 | |
| Trinity Medical Center - East | |
| Moline, Illinois, United States, 61265 | |
| Carle Cancer Center at Carle Foundation Hospital | |
| Urbana, Illinois, United States, 61801 | |
| CCOP - Carle Cancer Center | |
| Urbana, Illinois, United States, 61801 | |
| United States, Indiana | |
| Saint Anthony Memorial Health Centers | |
| Michigan City, Indiana, United States, 46360 | |
| United States, Iowa | |
| McFarland Clinic, PC | |
| Ames, Iowa, United States, 50010 | |
| Bettendorf, Iowa, United States, 52722 | |
| John Stoddard Cancer Center at Iowa Lutheran Hospital | |
| Des Moines, Iowa, United States, 50316-2301 | |
| John Stoddard Cancer Center at Iowa Methodist Medical Center | |
| Des Moines, Iowa, United States, 50309 | |
| Mercy Capitol Hospital | |
| Des Moines, Iowa, United States, 50307 | |
| Medical Oncology and Hematology Associates at Mercy Cancer Center | |
| Des Moines, Iowa, United States, 50314 | |
| Mercy Cancer Center at Mercy Medical Center - Des Moines | |
| Des Moines, Iowa, United States, 50314 | |
| Medical Oncology and Hematology Associates at John Stoddard Cancer Center | |
| Des Moines, Iowa, United States, 50309 | |
| CCOP - Iowa Oncology Research Association | |
| Des Moines, Iowa, United States, 50309 | |
| McCreery Cancer Center at Ottumwa Regional | |
| Ottumwa, Iowa, United States, 52501 | |
| Mercy Medical Center - Sioux City | |
| Sioux City, Iowa, United States, 51104 | |
| Siouxland Hematology-Oncology Associates, LLP | |
| Sioux City, Iowa, United States, 51101 | |
| St. Luke's Regional Medical Center | |
| Sioux City, Iowa, United States, 51104 | |
| Siouxland Regional Cancer Center | |
| Sioux City, Iowa, United States, 51101 | |
| Medical Oncology and Hematology Associates - West Des Moines | |
| West Des Moines, Iowa, United States, 50266 | |
| United States, Kansas | |
| Cancer Center of Kansas, PA - Chanute | |
| Chanute, Kansas, United States, 66720 | |
| Cancer Center of Kansas, PA - Dodge City | |
| Dodge City, Kansas, United States, 67801 | |
| Cancer Center of Kansas, PA - El Dorado | |
| El Dorado, Kansas, United States, 67042 | |
| Cancer Center of Kansas, PA - Kingman | |
| Kingman, Kansas, United States, 67068 | |
| Southwest Medical Center | |
| Liberal, Kansas, United States, 67901 | |
| Cancer Center of Kansas, PA - Newton | |
| Newton, Kansas, United States, 67114 | |
| Cancer Center of Kansas, PA - Parsons | |
| Parsons, Kansas, United States, 67357 | |
| Cancer Center of Kansas, PA - Pratt | |
| Pratt, Kansas, United States, 67124 | |
| Cancer Center of Kansas, PA - Salina | |
| Salina, Kansas, United States, 67042 | |
| Cancer Center of Kansas, PA - Wellington | |
| Wellington, Kansas, United States, 67152 | |
| Cancer Center of Kansas, PA - Wichita | |
| Wichita, Kansas, United States, 67214 | |
| CCOP - Wichita | |
| Wichita, Kansas, United States, 67214 | |
| Associates in Womens Health, PA - North Review | |
| Wichita, Kansas, United States, 67203 | |
| Cancer Center of Kansas, PA - Medical Arts Tower | |
| Wichita, Kansas, United States, 67208 | |
| Via Christi Cancer Center at Via Christi Regional Medical Center | |
| Wichita, Kansas, United States, 67214 | |
| Cancer Center of Kansas, PA - Winfield | |
| Winfield, Kansas, United States, 67156 | |
| United States, Michigan | |
| Green Bay Oncology, Limited - Escanaba | |
| Escanaba, Michigan, United States, 49431 | |
| Green Bay Oncology, Limited - Iron Mountain | |
| Iron Mountain, Michigan, United States, 49801 | |
| United States, Minnesota | |
| Alexandria, Minnesota, United States, 56308 | |
| MeritCare Clinic - Bemidji | |
| Bemidji, Minnesota, United States, 56601 | |
| Brainerd Medical Center | |
| Brainerd, Minnesota, United States, 56401 | |
| St. Joseph's Medical Center | |
| Brainerd, Minnesota, United States, 56401 | |
| Fairview Ridges Hospital | |
| Burnsville, Minnesota, United States, 55337 | |
| Mercy and Unity Cancer Center at Mercy Hospital | |
| Coon Rapids, Minnesota, United States, 55433 | |
| Fairview Southdale Hospital | |
| Edina, Minnesota, United States, 55435 | |
| Fergus Falls, Minnesota, United States, 56537 | |
| Mercy and Unity Cancer Center at Unity Hospital | |
| Fridley, Minnesota, United States, 55432 | |
| Hutchinson Area Health Care | |
| Hutchinson, Minnesota, United States, 55350 | |
| Meeker County Memorial Hospital | |
| Lichfield, Minnesota, United States, 55355 | |
| HealthEast Cancer Care at St. John's Hospital | |
| Maplewood, Minnesota, United States, 55109 | |
| Virginia Piper Cancer Institute at Abbott-Northwestern Hospital | |
| Minneapolis, Minnesota, United States, 55407 | |
| Hennepin County Medical Center - Minneapolis | |
| Minneapolis, Minnesota, United States, 55415 | |
| Chippewa County - Montevideo Hospital | |
| Montevideo, Minnesota, United States, 56265 | |
| Hubert H. Humphrey Cancer Center at North Memorial Medical Center | |
| Robbinsdale, Minnesota, United States, 55422-2900 | |
| Mayo Clinic Cancer Center | |
| Rochester, Minnesota, United States, 55905 | |
| Coborn Cancer Center | |
| Saint Cloud, Minnesota, United States, 56303 | |
| CCOP - Metro-Minnesota | |
| Saint Louis Park, Minnesota, United States, 55416 | |
| Adult and Pediatric Urology, P.L.L.P. | |
| Sartell, Minnesota, United States, 56377 | |
| Saint Francis Cancer Center | |
| Shakopee, Minnesota, United States, 55379 | |
| St. Joseph's Hospital | |
| St Paul, Minnesota, United States, 55102 | |
| CentraCare Clinic - River Campus | |
| St. Cloud, Minnesota, United States, 56303 | |
| Park Nicollet Health Services | |
| St. Louis Park, Minnesota, United States, 55416 | |
| United Hospital | |
| St. Paul, Minnesota, United States, 55102 | |
| Regions Hospital Cancer Care Center | |
| St. Paul, Minnesota, United States, 55101 | |
| Ridgeview Medical Center | |
| Waconia, Minnesota, United States, 55387 | |
| Woodwinds Health Campus | |
| Woodbury, Minnesota, United States, 55125 | |
| United States, North Carolina | |
| Rutherford Hospital | |
| Rutherfordton, North Carolina, United States, 28139 | |
| United States, North Dakota | |
| Bismarck Cancer Center | |
| Bismarck, North Dakota, United States, 58501 | |
| Medcenter One Hospital Cancer Care Center | |
| Bismarck, North Dakota, United States, 58501 | |
| St. Alexius Medical Center Cancer Center | |
| Bismarck, North Dakota, United States, 58502 | |
| Mid Dakota Clinic, PC | |
| Bismarck, North Dakota, United States, 58501 | |
| MeritCare Broadway | |
| Fargo, North Dakota, United States, 58122 | |
| CCOP - MeritCare Hospital | |
| Fargo, North Dakota, United States, 58122 | |
| United States, Oklahoma | |
| Natalie Warren Bryant Cancer Center at St. Francis Hospital | |
| Tulsa, Oklahoma, United States, 74136 | |
| United States, Pennsylvania | |
| Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest | |
| Allentown, Pennsylvania, United States, 18105 | |
| United States, South Carolina | |
| AnMed Cancer Center | |
| Anderson, South Carolina, United States, 29621 | |
| CCOP - Upstate Carolina | |
| Spartanburg, South Carolina, United States, 29303 | |
| Gibbs Regional Cancer Center at Spartanburg Regional Medical Center | |
| Spartanburg, South Carolina, United States, 29303 | |
| United States, South Dakota | |
| Rapid City Regional Hospital | |
| Rapid City, South Dakota, United States, 57701 | |
| Medical X-Ray Center, PC | |
| Sioux Falls, South Dakota, United States, 57105 | |
| Sioux Valley Hospital and University of South Dakota Medical Center | |
| Sioux Falls, South Dakota, United States, 57117-5039 | |
| Avera Cancer Institute | |
| Sioux Falls, South Dakota, United States, 57105 | |
| United States, Wisconsin | |
| Green Bay Oncology, Limited at St. Vincent Hospital | |
| Green Bay, Wisconsin, United States, 54301-3526 | |
| Green Bay Oncology, Limited at St. Mary's Hospital | |
| Green Bay, Wisconsin, United States, 54303 | |
| St. Mary's Hospital Medical Center - Green Bay | |
| Green Bay, Wisconsin, United States, 54303 | |
| St. Vincent Hospital Regional Cancer Center | |
| Green Bay, Wisconsin, United States, 54307-3508 | |
| Franciscan Skemp Healthcare - La Crosse Campus | |
| La Crosse, Wisconsin, United States, 54601 | |
| Bay Area Cancer Care Center at Bay Area Medical Center | |
| Marinette, Wisconsin, United States, 54143 | |
| Green Bay Oncology, Limited - Oconto Falls | |
| Oconto Falls, Wisconsin, United States, 54154 | |
| Green Bay Oncology, Limited - Sturgeon Bay | |
| Sturgeon Bay, Wisconsin, United States, 54235 | |
Sponsors and Collaborators
North Central Cancer Treatment Group
Investigators
| Study Chair: | Ravi D. Rao, MD, MBBS | Mayo Clinic |
| Investigator: | Harold E. Windschitl, MD | Coborn Cancer Center |
| Investigator: | William J. Maples, MD | Mayo Clinic |
| Investigator: | Michael K. Gornet, MD | Mayo Clinic |
| Investigator: | James N. Ingle, MD | Mayo Clinic |
| Investigator: | Edward T. Creagan, MD | Mayo Clinic |
| Investigator: | Judith S. Kaur, MD | Mayo Clinic |
| Investigator: | Barbara A. Pockaj, MD | Mayo Clinic Hospital |
| Investigator: | Evanthia Galanis, MD | Mayo Clinic |
| Investigator: | Charles L. Loprinzi, MD | Mayo Clinic |
| Investigator: | Henry C. Pitot, MD | Mayo Clinic |
| Investigator: | Lori A. Erickson, MD | Mayo Clinic |
| Investigator: | Val J. Lowe, MD | Mayo Clinic |
More Information
Additional Information:
Publications:
Rao RD, Allred JB, Windschitl HE, et al.: N0377: results of NCCTG phase II trial of the mTOR inhibitor RAD-001 in metastatic melanoma. [Abstract] J Clin Oncol 25 (Suppl 18): A-8530, 479s, 2007.
Rao RD, Windschitl HE, Allred JB, et al.: Phase II trial of the mTOR inhibitor everolimus (RAD-001) in metastatic melanoma. [Abstract] J Clin Oncol 24 (Suppl 18): A-8043, 463s, 2006.
| ClinicalTrials.gov Identifier: | NCT00098553 History of Changes |
| Other Study ID Numbers: | CDR0000402871, NCCTG-N0377 |
| Study First Received: | December 7, 2004 |
| Last Updated: | June 17, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
stage IV melanoma recurrent melanoma |
Additional relevant MeSH terms:
|
Melanoma Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Nerve Tissue Nevi and Melanomas Everolimus Sirolimus |
Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses Antifungal Agents Anti-Infective Agents Anti-Bacterial Agents |
ClinicalTrials.gov processed this record on May 23, 2013