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)
18 Years
N/A
Both
Melanoma (Skin)
Trial Information
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)
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.
Inclusion Criteria
DISEASE CHARACTERISTICS: Histologically proven malignant melanoma that is surgically or
medically incurable Measurable or evaluable metastatic disease OR No evidence of disease
following surgical resection of a distant metastasis OR Surgical resection of at least 2
local or regional recurrences, at least 1 of which had evidence of lymph node involvement
Each recurrence at least 1 month apart
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0 or 1 Life expectancy:
Greater than 3 months Hematopoietic: WBC at least 3500/mm3 Platelet count at least
100,000/mm3 Hemoglobin at least 10.0 g/dL Hepatic: Bilirubin less than 2.0 mg/dL SGOT less
than 3 times normal Renal: Creatinine less than 2.0 mg/dL Other: Not pregnant Fertile
patients must use effective contraception HIV negative No active infections requiring
antibiotic, antiviral, or antifungal therapy No other active malignancy No concurrent
significant illnesses
PRIOR CONCURRENT THERAPY: Biologic therapy: At least 1 month since prior immunotherapy
Chemotherapy: At least 1 month since prior chemotherapy No more than 2 prior chemotherapy
regimens for melanoma Endocrine therapy: At least 1 month since prior steroids (except
intermittent use as antiemetic or as topical agent) No concurrent steroids Radiotherapy:
At least 1 month since prior radiotherapy No prior radiotherapy to vaccine site Surgery:
No prior organ allografts
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Mark R. Albertini, MD
Investigator Role:
Study Chair
Investigator Affiliation:
University of Wisconsin, Madison
Authority:
United States: Federal Government
Study ID:
CDR0000067067
NCT ID:
NCT00003897
Start Date:
May 1999
Completion Date:
Related Keywords:
- Melanoma (Skin)
- stage IV melanoma
- recurrent melanoma
- Melanoma
Name | Location |
|---|---|
| University of Wisconsin Comprehensive Cancer Center | Madison, Wisconsin 53792 |
