Vaccine Therapy in Treating Patients With Metastatic Melanoma
Recruitment status was: Active, not recruiting
RATIONALE: Vaccines may make the body build an immune response to kill melanoma cells.
PURPOSE: Phase I/II trial to study the effectiveness of vaccine therapy in treating patients with metastatic melanoma.
|Melanoma (Skin)||Biological: sargramostim Biological: vaccinia-GM-CSF vaccine||Phase 1 Phase 2|
|Study Design:||Primary Purpose: Treatment|
|Official Title:||INTRALESIONAL IMMUNOTHERAPY WITH A VACCINIA/GM-CSF RECOMBINANT VIRUS IN PATIENTS WITH METASTATIC MELANOMA|
|Study Start Date:||April 1996|
OBJECTIVES: I. Determine the toxicity of intralesional immunotherapy with a recombinant vaccinia virus encoding the gene for sargramostim (GM-CSF) in patients with metastatic melanoma. II. Determine the efficiency of viral infection and GM-CSF gene insertion and function in these patients. III. Determine the capacity of this regimen to generate antiviral and antitumor immunity in these patients. IV. Determine the frequency of regression of injected and uninjected lesions in these patients.
OUTLINE: This is a dose-escalation study of intralesional recombinant vaccinia virus encoding the gene for sargramostim (GM-CSF) (rV-GM-CSF). Patients are stratified by center. Patients receive small pox (vaccinia) vaccine via multipuncture technique on day 0. On day 4, patients with a progressive major reaction to the initial vaccination receive rV-GM-CSF intralesionally twice weekly for 5 weeks. Only 1 lesion is treated and at least 1 measurable lesion is left untreated in each patient. Patients with responding disease after week 5 are retreated at a clinically appropriate dose and schedule. Cohorts of 5 patients receive escalating doses of intralesional rV-GM-CSF until the maximum tolerated dose (MTD) is determined. Additional patients receive rV-GM-CSF at the MTD.
PROJECTED ACCRUAL: Approximately 30 patients (15 for each phase) will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002817
|United States, Pennsylvania|
|Kimmel Cancer Center of Thomas Jefferson University - Philadelphia|
|Philadelphia, Pennsylvania, United States, 19107-5541|
|Study Chair:||Michael J. Mastrangelo, MD||Sidney Kimmel Cancer Center at Thomas Jefferson University|