Spots Global Cancer Trial Database for Perifosine in Treating Patients With Metastatic or Recurrent Malignant Melanoma

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Trial Identification

Brief Title: Perifosine in Treating Patients With Metastatic or Recurrent Malignant Melanoma

Official Title: A Phase II Study Of Perifosine (D-21266) In Previously Untreated Patients With Metastatic Or Recurrent Malignant Melanoma

Study ID: NCT00053781

Conditions

Melanoma (Skin)

Interventions

perifosine

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 perifosine in treating patients who have metastatic or recurrent malignant melanoma.

Detailed Description: OBJECTIVES: * Determine the efficacy of perifosine, in terms of response rate, in previously untreated patients with metastatic or recurrent malignant melanoma. * Assess the toxicity of this drug in these patients. OUTLINE: This is a multicenter study. Patients receive oral perifosine daily on days 1-21. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve a complete response (CR) or partial response (PR) receive 2 additional courses after documentation of CR or stable PR (i.e., no further tumor shrinkage). Patients are followed at 4 weeks and then every 3 months thereafter. PROJECTED ACCRUAL: A total of 15-30 patients will be accrued for this study within 12-18 months.