Vaccine Therapy With or Without 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: NCT00019448|
Recruitment Status : Completed
First Posted : March 5, 2007
Last Update Posted : June 20, 2013
RATIONALE: Vaccines made from DNA may make the body build an immune response to kill tumor cells. Interleukin-2 may stimulate a person's white blood cells to kill melanoma cells. Combining vaccine therapy and interleukin-2 may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of vaccine therapy with or without interleukin-2 in treating patients with metastatic melanoma that has not responded to previous treatment.
|Condition or disease||Intervention/treatment||Phase|
|Stage IV Melanoma Recurrent Melanoma||Drug: gp100 antigen Drug: interleukin-2||Phase 2|
OBJECTIVES: I. Determine the clinical response of patients receiving DNA gp100 antigen alone or in combination with interleukin-2 for recurrent metastatic melanoma.
II. Identify the immunologic response in these patients prior to and after these treatments.
III. Determine the toxicity of these treatments in these patients.
PROTOCOL OUTLINE: Patients are accrued for the first three cohorts and the study proceeds to the final two cohorts if responses are observed.
Cohort I: Patients receive gp100 antigen intramuscularly (IM) into each of 2 proximal extremities once every 4 weeks for up to 4 doses. (Closed as of December, 1999) Cohort II: Patients receive gp100 antigen intradermally (ID) at 5 sites on each of 2 proximal extremities once every 4 weeks for up to 4 doses. (Closed as of December, 1999) Cohort III: Patients receive gp100 antigen IM into each of 2 proximal extremities once every 4 weeks for up to 4 doses. If patients do not exhibit immunologic response or dose-limiting toxicity, they may receive a higher dose of gp100 antigen on subsequent courses.
Cohort IV: If cohorts I, II, or III do not produce an immune response and do not experience dose-limiting toxicity, patients receive a higher dose of gp100 antigen IM into each of 2 proximal extremities every 4 weeks for up to 4 doses.
Cohort V: Patients receive gp100 antigen IM or ID at the dose found to produce immunization once every 4 weeks for up to 4 doses. Patients also receive interleukin-2 IV over 15 minutes every 8 hours for 5 days (15 doses), beginning within 24 hours after gp100 antigen.
Patients with minor, mixed, or partial response or stable disease may receive additional courses of treatment following 3-4 weeks of rest. Patients receive a maximum of 12 courses.
Patients are followed at 4-6 weeks.
A maximum of 65 patients will be accrued for this study within 1 year.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||Phase II Study of DNA Encoding the gp100 Antigen Alone or in Combination With Interleukin-2 in Patients With Recurrent Metastatic Melanoma|
|Study Start Date :||September 1998|
|Actual Study Completion Date :||March 2007|
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): NCT00019448
|United States, Maryland|
|Bethesda, Maryland, United States, 20892|
|Study Chair:||Steven A. Rosenberg||National Cancer Institute (NCI)|