Interferon Beta in Treating Patients With Metastatic Cutaneous Melanoma or Ocular Melanoma
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.
|Stage IV Melanoma Recurrent Melanoma||Biological: recombinant interferon beta||Phase 2|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Phase II Trial Of Interferon-B In Patients With Metastatic Cutaneous Melanoma And Metastatic Ocular Melanoma|
- 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
|Study Start Date:||April 2004|
|Study Completion Date:||October 2007|
|Primary Completion Date:||October 2007 (Final data collection date for primary outcome measure)|
|Experimental: Recombinant interferon beta||
Biological: recombinant interferon beta
recombinant interferon beta
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00085306
|United States, Ohio|
|Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center|
|Cleveland, Ohio, United States, 44195|
|Study Chair:||Ernest C. Borden, MD||Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center|