Sorafenib in Treating Patients With Stage III or Stage IV Melanoma That Cannot Be Removed By Surgery

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

Sorafenib 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. This phase II trial is studying how well sorafenib works in treating patients with stage III or stage IV melanoma that cannot be removed by surgery

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Niacinamide; Sorafenib

Criteria

Inclusion Criteria:

• Histologically or cytologically confirmed unresectable melanoma

• Stage III or IV disease

• Measurable disease, defined as ≥ 1 unidimensionally measurable lesion > 20 mm by conventional techniques OR > 10 mm by spiral CT scan

• Disease amenable to biopsy (first 13 patients in each stratum only)

• Brain metastases allowed provided the following criteria are met:

• Disease has remained radiologically stable for ≥ 6 weeks after completion of whole-brain radiotherapy and remains stable at the time of study entry

• No mass effect present by radiology

• No requirement for steroid therapy to control symptoms of brain metastases

• Performance status - ECOG 0-2

• Performance status - Karnofsky 60-100%

• At least 3 months

• Absolute neutrophil count ≥ 1,500/mm^3

• Platelet count ≥ 100,000/mm^3

• No evidence of bleeding diathesis

• AST and ALT ≤ 2.5 times upper limit of normal (ULN)

• Bilirubin ≤ 2 times ULN

• Creatinine ≤ 1.5 times ULN

• No uncontrolled hypertension

• No symptomatic congestive heart failure

• No unstable angina pectoris

• No cardiac arrhythmia

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No psychiatric illness that would preclude study compliance

• No pre-existing non-hematological dysfunction ≥ grade 2

• No ongoing or active infection

• No history of serious allergic reaction to eggs

• Able to swallow pills

• No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or other non-invasive carcinoma

• No other uncontrolled illness

• Not specified

• No prior systemic chemotherapy for metastatic disease

• See Disease Characteristics

• See Disease Characteristics

• No other concurrent investigational agents

• No concurrent therapeutic anticoagulation

• No concurrent combination antiretroviral therapy for HIV-positive patients

• No other concurrent anticancer therapy