Melanoma (Skin) Clinical Trial
Official title:
A Phase II Study of SB-715992 (NSC 727990) in Previously Untreated Patients With Metastatic or Recurrent Malignant Melanoma
RATIONALE: Drugs used in chemotherapy, such as SB-715992, work in different ways to stop
tumor cells from dividing so they stop growing or die.
PURPOSE: This phase II trial is studying how well SB-715992 works in treating patients with
metastatic or recurrent malignant melanoma.
OBJECTIVES:
- Determine the efficacy of SB-715992, in terms of response rate, in patients with
previously untreated metastatic or recurrent malignant melanoma.
- Determine the toxic effects of this drug in these patients.
- Determine the early progression rate and response duration in patients treated with
this drug.
- Determine the pharmacokinetics of this drug in these patients.
- Correlate pharmacokinetics with safety and efficacy endpoints of this drug in these
patients.
- Correlate β-tubulin and kinesin spindle protein expression in tumor tissue with
clinical outcomes in patients treated with this drug.
OUTLINE: This is a nonrandomized, multicenter study.
Patients receive SB-715992 IV over 1 hour on day 1. Courses repeat every 21 days in the
absence of disease progression or unacceptable toxicity.
All patients are followed at 4 weeks after completion of protocol therapy. Patients with
ongoing complete response, partial response, or stable disease are followed every 3 months
thereafter until relapse.
PROJECTED ACCRUAL: A total of 15-25 patients will be accrued for this study within 12-14
months.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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