Cilengitide in Treating Patients With Unresectable or Metastatic Melanoma

Stage IV Melanoma Clinical Trial

Official title: A Phase 2 Study of EMD 121974 (Cilengitide, NSC 707544) in Patients With Metastatic Melanoma

Status Terminated

Clinical Trial Summary

This randomized phase II trial is studying how well cilengitide works in treating patients with unresectable stage III or stage IV melanoma. Cilengitide may stop the growth of melanoma by stopping blood flow to the tumor.

Clinical Trial Description

PRIMARY OBJECTIVES:

I. To evaluate the clinical efficacy of EMD 121974 at two different doses in patients with metastatic melanoma by determining the progression-free survival rate at 8 weeks.

SECONDARY OBJECTIVES:

I. To determine the response rate of EMD 121974 in patients with metastatic melanoma.

II. To determine the overall survival in patients who receive EMD 121974. III. To determine the safety and toxicity of EMD 121974 in patients with metastatic melanoma.

IV. To determine the population pharmacokinetics of EMD 121974. V. To determine the biological activity of EMD 121974 in melanoma cells of patients who are treated with the drug.

VI. To evaluate the use of optical imaging and functional dynamic imaging scans in assessing biological activity of EMD 121974.

OUTLINE: This is a randomized, double-blind study. Patients are stratified according to prior systemic treatment (yes vs no), visceral metastases (yes vs no), serum lactic dehydrogenase level (normal vs abnormal), and tumor integrin α_vβ_3 overexpression (yes vs no). Patients are randomized into 1 of 2 treatment arms.

ARM I: Patients receive cilengitide IV over 1 hour on days 1, 4, 8, 11*, 15, 18, 22, and 25. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

NOTE: *For the first course only, treatment is omitted on day 11.

ARM II: Patients receive cilengitide as in arm I at a higher dose.

After completion of study treatment, patients are followed every 3 months for 1 year and then every 6 months thereafter. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Melanoma
• Stage III Melanoma
• Stage IV Melanoma

• NCT number: NCT00082875
• Study type: Interventional
• Source: National Cancer Institute (NCI)
• Status: Terminated
• Phase: Phase 2
• Start date: March 2004