Spots Global Cancer Trial Database for E7070 in Treating Patients With Stage IV Melanoma

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Trial Identification

Brief Title: E7070 in Treating Patients With Stage IV Melanoma

Official Title: Open Label Phase II Study Of E7070 In Patients With Metastatic Melanoma (Stage IV)

Study ID: NCT00014625

Conditions

Melanoma (Skin)

Interventions

indisulam

Study Description

Brief Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of E7070 in treating patients who have stage IV melanoma.

Detailed Description: OBJECTIVES: I. Determine the therapeutic activity of E7070 in terms of objective response, duration of response, and progression-free survival of patients with metastatic melanoma. II. Determine the acute side effects of this drug in these patients. III. Determine the pharmacokinetic parameters of this drug in these patients. OUTLINE: This is a multicenter study. Patients receive E7070 IV over 1 hour. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed every 6 weeks. PROJECTED ACCRUAL: A total of 19-24 patients will be accrued for this study.