Interleukin-2 in Treating Patients With Metastatic Melanoma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00002845|
Recruitment Status : Unknown
Verified May 2000 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : August 24, 2004
Last Update Posted : December 19, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Melanoma (Skin)||Biological: aldesleukin||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Official Title:||TREATMENT OF METASTATIC MELANOMA WITH RECOMBINANT INTERLEUKIN-2|
|Study Start Date :||September 1995|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|