NCT00085306

Interferon Beta in Treating Patients With Metastatic Cutaneous Melanoma or Ocular Melanoma

Phase II Trial Of Interferon-B In Patients With Metastatic Cutaneous Melanoma And Metastatic Ocular Melanoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Case Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Interferon beta may interfere with the growth of tumor cells. PURPOSE: This phase II trial is studying how well interferon beta works in treating patients with metastatic cutaneous (skin) melanoma or ocular (eye) melanoma.

Detailed description

OBJECTIVES: * Determine the objective clinical response rate in patients with metastatic cutaneous or ocular melanoma treated with interferon beta. * Determine the frequency and degree of apoptosis induction in patients treated with this drug. * Determine the safety and tolerability of this drug in these patients. OUTLINE: This is an open-label study. Patients are stratified according to type of melanoma (ocular vs cutaneous). Patients receive interferon beta subcutaneously once daily in the absence of disease progression or unacceptable toxicity. Patients are followed within 3 days after completion of study treatment and then for survival. PROJECTED ACCRUAL: A total of 28-56 patients (14-28 per stratum) will be accrued for this study.

Conditions

• Stage IV Melanoma
• Recurrent Melanoma

Interventions

Type	Name	Description
BIOLOGICAL	recombinant interferon beta	recombinant interferon beta

Timeline

• Start date: 2004-04-01
• Primary completion: 2007-10-01
• Completion: 2007-10-01
• First posted: 2004-06-11
• Last updated: 2015-10-02

Locations

1 site across 1 country: United States