Vaccine Therapy With gp100 and/or Sargramostim in Treating Patients With Malignant 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. Identifier: NCT00003897
Recruitment Status : Completed
First Posted : August 18, 2004
Last Update Posted : July 23, 2015
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Wisconsin, Madison

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Melanoma (Skin) Biological: gp100 antigen Biological: sargramostim Phase 1

Detailed Description:

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
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
Actual Primary Completion Date : March 2001
Actual Study Completion Date : December 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00003897

United States, Wisconsin
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
University of Wisconsin, Madison
National Cancer Institute (NCI)
Study Chair: Mark R. Albertini, MD University of Wisconsin, Madison

Responsible Party: University of Wisconsin, Madison Identifier: NCT00003897     History of Changes
Other Study ID Numbers: CO98601
U01CA061498 ( U.S. NIH Grant/Contract )
First Posted: August 18, 2004    Key Record Dates
Last Update Posted: July 23, 2015
Last Verified: July 2015

Keywords provided by University of Wisconsin, Madison:
stage IV melanoma
recurrent melanoma

Additional relevant MeSH terms:
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas