Melanoma (Skin) Clinical Trial
Official title:
INTRALESIONAL IMMUNOTHERAPY WITH A VACCINIA/GM-CSF RECOMBINANT VIRUS IN PATIENTS WITH METASTATIC MELANOMA
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.
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.
;
Primary Purpose: Treatment
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