Interferon Beta in Treating Patients With Metastatic Cutaneous Melanoma or Ocular Melanoma
- Conditions
- Recurrent MelanomaStage IV Melanoma
- Interventions
- Biological: recombinant interferon beta
- Registration Number
- NCT00085306
- Lead Sponsor
- Case Comprehensive Cancer Center
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 21
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Recombinant interferon beta recombinant interferon beta -
- Primary Outcome Measures
Name Time Method Objective clinical response rate to IFN-B the maximum tolerated dose as measured by a CTC Grade III hematologic or a Grade IV granulocyte toxicity which persists > 3 days at 1 week after each course
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
🇺🇸Cleveland, Ohio, United States