NCT00087477

A Pilot Study of Pivanex in Patients With Malignant Melanoma

A Pilot Study of Pivanex, a Histone Deacetylase Inhibitor, in Patients With Malignant Melanoma

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 14 (planned)
• Sponsor: Titan Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This pilot study will assess the safety and efficacy of Pivanex alone in patients with malignant melanoma who have relapsed after treatment with chemotherapy or Interleukin-2 (IL-2). Pivanex is an investigational agent.

Detailed description

Rationale: Pivanex is a histone deacetylase inhibitor that induces tumor differentiation, inhibits proliferation, and induces apoptosis. Pivanex has been generally well tolerated in clinical trials and has shown preliminary evidence of efficacy in patients with non-small cell lung cancer. Pivanex has shown in-vitro and in-vivo evidence of anti-tumor activity against melanoma and, therefore, represents a promising therapeutic approach to patients with malignant melanoma. Purpose: This open-label trial will determine the response rate of Pivanex in patients with malignant melanoma. Objectives: * Determine time to disease progression * Determine overall survival * Determine the safety profile of Pivanex in malignant melanoma Outline: This is an open-label, single center study in patients with malignant melanoma whose disease has progressed or failed to respond to chemotherapy or Interleukin-2 (IL-2). Patients will be treated with 2.5 g/m2 of Pivanex administered intravenously over 6 hours daily on Days 1 - 3. Treatment will be repeated every 21 days until tumor progression or the patient is withdrawn from treatment for other protocol-specified reasons. Tumor status will be assessed prior to every odd-numbered treatment cycle using the Response Evaluation Criteria in Solid Tumors (RECIST) method. Patients who continue to experience tumor response or stabilization at the time treatment is discontinued will be followed every 12 weeks for tumor status until disease progression.

Conditions

• Malignant Melanoma

Interventions

Type	Name	Description
DRUG	Pivanex

Timeline

• Start date: 2004-01-01
• Completion: 2004-08-01
• First posted: 2004-07-13
• Last updated: 2005-08-30

Locations

1 site across 1 country: United States