NCT00053781

Perifosine in Treating Patients With Metastatic or Recurrent Malignant Melanoma

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: NCIC Clinical Trials Group · Network
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Melanoma (Skin)

Interventions

Type	Name	Description
DRUG	perifosine

Timeline

• Start date: 2003-06-20
• Primary completion: 2004-09-14
• Completion: 2009-12-21
• First posted: 2003-02-06
• Last updated: 2023-08-04

Locations

6 sites across 1 country: Canada

Regulatory

• FDA-regulated drug study