Stage IV Melanoma Clinical Trial
Official title:
Phase II Trial of 17-N-allylamino-17-demethoxy Geldanamycin (17-AAG, NSC #330507) Diluted in EPL Diluent (NSC #704057) in Metastatic Melanoma Patients
This phase II trial is studying how well tanespimycin works in treating patients with stage III or stage IV melanoma. Antitumor antibiotics such as tanespimycin may stop the growth of melanoma by stopping blood flow to the tumor.
PRIMARY OBJECTIVES:
I. Determine if treatment with 17-AAG results in measurable anti-tumor effects and calculate
the proportion of clinical responses.
II. Test the hypothesis that treatment with 17-AAG can disrupt the MAPK pathway by depleting
intra-tumor stores of RAF kinases and/or downstream proteins such as phospho-ERK, CDK4 and
cyclin D1.
III. Determine if either of these effects correlates with the presence of mutated BRAF
within the melanoma tumor.
OUTLINE: This is a multicenter study. Patients are stratified according to presence of BRAF
mutation in tumor (yes vs no).
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.
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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