Vaccine Therapy With gp100 and/or Sargramostim in Treating Patients With Malignant Melanoma
RATIONALE: Vaccines made from gp100 and sargramostim may make the body build an immune response to kill tumor cells.
PURPOSE: Phase I trial to study the effectiveness of vaccine therapy with gp100 and/or sargramostim in treating patients who have malignant melanoma.
|Melanoma (Skin)||Biological: gp100 antigen Biological: sargramostim||Phase 1|
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Phase I Trial of Immunization Using Particle-Mediated Transfer of Genes for GP-100 and GM-CSF Into Uninvolved Skin of Patients With Melanoma (Summary Last Modified 7/1999)|
|Study Start Date:||May 1999|
|Study Completion Date:||December 2006|
|Primary Completion Date:||March 2001 (Final data collection date for primary outcome measure)|
OBJECTIVES: I. Determine the safety and toxicity of in vivo particle bombardment with DNA coated gold beads carrying cDNA for gp100, with or without gold beads carrying cDNA for sargramostim (GM-CSF), into uninvolved skin of patients with melanoma. II. Estimate the intensity and duration of gp100 transgene expression following these regimens in these patients. III. Assess local lymphocyte phenotype and systemic lymphocyte function following these regimens in these patients. IV. Compare gp100 transgene expression as well as local lymphocyte phenotype and systemic lymphocyte function when the cDNA for GM-CSF is administered 3 days before cDNA for gp100 vs on the same day as gp100 administration in these patients. V. Determine the effect of these regimens on tumor shrinkage, histological evidence of tumor inflammation or necrosis, or in vitro evidence of antitumor immune reactivity in these patients.
OUTLINE: This is a dose escalation study. Patients are assigned to one of three treatment groups. Group I: Patients receive particle mediated gene transfer (PMGT) of gp100 on day 1 to 2 or 4 separate sites. One site is biopsied on day 3. A second course is administered on day 22 and one of the sites is biopsied on day 26. Delayed type hypersensitivity (DTH) is assessed on days 40 and 43. Group II: Patients receive PMGT of sargramostim (GM-CSF) on day 1 to 1-5 separate sites. PMGT of gp100 is administered to 2-4 of these same sites on day 4. One of the gp100 sites is biopsied on day 6. A second course is administered beginning on day 22, with one of the sites biopsied on day 29. DTH is assessed on days 40 and 43. Group III: Patients receive PMGT of GM-CSF in combination with gp100 on day 1 to 2 or 4 separate sites. Courses are administered as in group I. Patients who achieve partial or complete response or maintain stable disease may receive another course of therapy. Cohorts of 3-6 patients are treated at each dose in each group until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity. Patients are followed at 3, 6, and 12 months, and then annually thereafter.
PROJECTED ACCRUAL: A total of 18 patients will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003897
|United States, Wisconsin|
|University of Wisconsin Comprehensive Cancer Center|
|Madison, Wisconsin, United States, 53792|
|Study Chair:||Mark R. Albertini, MD||University of Wisconsin, Madison|