Tanespimycin in Treating Patients With Stage III-IV Melanoma
Recurrent Melanoma, Stage III Melanoma, Stage IV Melanoma
About this trial
This is an interventional treatment trial for Recurrent Melanoma
Eligibility Criteria
Inclusion Criteria: Histologically or cytologically confirmed melanoma Stage III or IV disease No primary melanoma of the choroid or mucosa Measurable disease At least 1 unidimensionally measurable lesion >= 20 mm by conventional techniques OR >= 10 mm by spiral CT scan Tumor amenable to biopsy (for the first 10 patients in each stratum only) Patients must have measurable disease in addition to the tumor(s) to be biopsied No brain or epidural metastases Completely resected solitary brain metastases allowed provided patient has been free of CNS metastases for >= 6 months Performance status - Karnofsky 60-100% Performance status - ECOG 0-2 More than 3 months Absolute neutrophil count >= 1,500/mm^3 Platelet count >= 100,000/mm^3 WBC >= 3,000/mm^3 AST and ALT =< 2.5 times upper limit of normal Creatinine normal No symptomatic congestive heart failure No unstable angina pectoris No cardiac arrhythmia No history of myocardial infarction No history of prolonged QTc interval No active ischemic heart disease within the past 12 months No uncontrolled dysrhythmia or dysrhythmias requiring medication No congenital prolonged QT syndrome No left bundle branch block Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No prior allergic reaction attributed to compounds of similar chemical or biological composition to 17-N-allylamino-17-demethoxygeldanamycin (17-AAG) No prior serious allergic reaction to eggs No other uncontrolled illness No active or ongoing infection requiring systemic antimicrobial treatment No psychiatric illness or social situation that would preclude study compliance No more than 1 prior chemotherapy regimen for metastatic melanoma Prior vaccines, cytokines, or interferon alfa is not considered prior therapy unless administered with a chemotherapy drug More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered Prior radiotherapy dose =< 3,000 cGy to fields including substantial marrow More than 4 weeks since prior radiotherapy and recovered No prior radiotherapy field that included the heart (e.g., mantle) No concurrent combination antiretroviral therapy for HIV-positive patients No concurrent medications that may prolong the QTc interval No other concurrent anticancer therapy No other concurrent investigational agents No concurrent treatment with any of the following medications or herbal remedies: Inhibitors of CYP3A4: Fluconazole Itraconazole Ketoconazole Macrolide antibiotics (azithromycin, clarithromycin, erythromycin, or troleandomycin) Midazolam Nifedipine Verapamil Diltiazem Terfenadine Cyclosporine Cisapride Inducers of CYP3A4: Carbamazepine Phenobarbital Phenytoin Rifampin Herbal extracts and tinctures with CYP3A4 inhibitory activity: Hydrastis canadensis (goldenseal) Hypericum perforatum (St. John's wort) Uncaria tomentosa (cat's claw) Echinacea angustifolia roots Trifolium pratense (wild cherry) Matricaria chamomilla (chamomile) Glycyrrhiza glabra (licorice) Dillapiol Hypericin Naringin No other concurrent herbal extracts
Sites / Locations
- Memorial Sloan-Kettering Cancer Center
Arms of the Study
Arm 1
Experimental
Treatment (tanespimycin)
Patients receive tanespimycin IV over 1-6 hours once weekly for 6 weeks. Courses repeat every 56 days in the absence of disease progression or unacceptable toxicity.