Everolimus in Treating Patients With Stage IV Melanoma
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| ClinicalTrials.gov Identifier: NCT00098553 |
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Recruitment Status :
Completed
First Posted : December 8, 2004
Last Update Posted : July 6, 2016
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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 or disease | Intervention/treatment | Phase |
|---|---|---|
| Melanoma (Skin) | Drug: everolimus | Phase 2 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 53 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Phase II Trial Of RAD-001 In Metastatic Malignant Melanoma |
| Study Start Date : | April 2005 |
| Actual Primary Completion Date : | July 2007 |
| Actual Study Completion Date : | February 2010 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: everolimus
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. |
Drug: everolimus |
- Proportion of patients with progression-free disease at 16 weeks [ Time Frame: at 16 weeks ]
- Median overall survival [ Time Frame: Up to 5 years ]
- Tumor response rate for 2 consecutive evaluations at least 8 weeks apart [ Time Frame: Up to 5 years ]
- Toxicity as measured by CTCAE v. 3.0 [ Time Frame: Up to 5 years ]
- disease progression [ Time Frame: at 16 weeks ]
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, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
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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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00098553
Show 94 study locations
| Study Chair: | Ravi D. Rao, MD, MBBS | Mayo Clinic | |
| OverallOfficial: | Harold E. Windschitl, MD | Coborn Cancer Center | |
| OverallOfficial: | William J. Maples, MD | Mayo Clinic | |
| OverallOfficial: | Michael K. Gornet, MD | Mayo Clinic | |
| OverallOfficial: | James N. Ingle, MD | Mayo Clinic | |
| OverallOfficial: | Edward T. Creagan, MD | Mayo Clinic | |
| OverallOfficial: | Judith S. Kaur, MD | Mayo Clinic | |
| OverallOfficial: | Barbara A. Pockaj, MD | Mayo Clinic Hospital | |
| OverallOfficial: | Evanthia Galanis, MD | Mayo Clinic | |
| OverallOfficial: | Charles L. Loprinzi, MD | Mayo Clinic | |
| OverallOfficial: | Henry C. Pitot, MD | Mayo Clinic | |
| OverallOfficial: | Lori A. Erickson, MD | Mayo Clinic | |
| OverallOfficial: | Val J. Lowe, MD | Mayo Clinic |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Alliance for Clinical Trials in Oncology |
| ClinicalTrials.gov Identifier: | NCT00098553 |
| Other Study ID Numbers: |
NCCTG-N0377 NCI-2012-02640 ( Registry Identifier: CTRP (Clinical Trials Reporting System) ) CDR0000402871 ( Registry Identifier: PDQ (Physician Data Query) ) |
| First Posted: | December 8, 2004 Key Record Dates |
| Last Update Posted: | July 6, 2016 |
| Last Verified: | July 2016 |
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stage IV melanoma recurrent melanoma |
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Melanoma Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Nerve Tissue |
Nevi and Melanomas Everolimus Antineoplastic Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |