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Everolimus in Treating Patients With Stage IV Melanoma

Phase II Trial Of RAD-001 In Metastatic Malignant Melanoma

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00098553
Enrollment
53
Registered
2004-12-08
Start date
2005-04-30
Completion date
2010-02-28
Last updated
2016-07-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Melanoma (Skin)

Keywords

stage IV melanoma, recurrent melanoma

Brief summary

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.

Detailed description

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.

Interventions

DRUGeverolimus

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Alliance for Clinical Trials in Oncology
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion 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

Design outcomes

Primary

MeasureTime frame
Proportion of patients with progression-free disease at 16 weeksat 16 weeks

Secondary

MeasureTime frame
Median overall survivalUp to 5 years
Tumor response rate for 2 consecutive evaluations at least 8 weeks apartUp to 5 years
Toxicity as measured by CTCAE v. 3.0Up to 5 years
disease progressionat 16 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026