Sorafenib in Treating Patients With Stage III or Stage IV Melanoma That Cannot Be Removed By Surgery
Completed · Phase 2
Conditions studied: Stage III Melanoma, Stage IV Melanoma
In brief
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
Key facts
- Study ID
- NCT00119249
- Run by
- National Cancer Institute (NCI)
- People needed
- 74
- Starts
- 2005-06-01
- Last updated by the study team
- 2013-01-15
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
Where it is running
- Montefiore Medical Center — The Bronx, New York, United States
Full record on ClinicalTrials.gov
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