Interleukin-2 in Treating Patients With Metastatic Melanoma
Recruitment status was: Active, not recruiting
RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill melanoma cells.
PURPOSE: Phase II trial to study the effectiveness of interleukin-2 in treating patients who have metastatic melanoma.
|Study Design:||Primary Purpose: Treatment|
|Official Title:||TREATMENT OF METASTATIC MELANOMA WITH RECOMBINANT INTERLEUKIN-2|
|Study Start Date:||September 1995|
OBJECTIVES: I. Evaluate the response and survival rates of patients with metastatic melanoma following induction with high-dose and maintenance with low-dose interleukin-2. II. Assess the toxicity of this regimen.
OUTLINE: All patients receive high-dose interleukin-2 over 24 hours, followed by low-dose interleukin-2 for 4 days in the absence of toxicity. Patients receive a second cycle beginning 9-13 days after completion of the first cycle, with response assessed approximately 2 months after initiating therapy. Patients with stable or responding disease receive a second course as above; those with a continued response may receive additional courses provided toxicity is limited. Patients are followed for survival.
PROJECTED ACCRUAL: 20 patients will be entered.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002845
|United States, North Carolina|
|Carolinas Medical Center|
|Charlotte, North Carolina, United States, 28232-2861|
|Study Chair:||Richard L. White, MD||Blumenthal Cancer Center at Carolinas Medical Center|