Everolimus in Treating Patients With Stage IV Melanoma

Alliance for Clinical Trials in Oncology

Status and phase: Completed; Phase 2

Conditions: Melanoma (Skin)

Treatments: Drug: everolimus

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00098553

CDR0000402871 (Registry Identifier)

NCI-2012-02640 (Registry Identifier)

NCCTG-N0377

Details and patient eligibility

About

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.

Full 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.

Enrollment: 53 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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53 participants in 1 patient group

everolimus

Experimental group

Description:

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.

Treatment:

Drug: everolimus