Phase II Trial Of Interferon-B In Patients With Metastatic Cutaneous Melanoma And Metastatic Ocular Melanoma
- 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
- 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
PROJECTED ACCRUAL: A total of 28-56 patients (14-28 per stratum) will be accrued for this
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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
Ernest C. Borden, MD
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
United States: Food and Drug Administration
|Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center||Cleveland, Ohio 44195|