Vaccine Therapy With gp100 and/or Sargramostim in Treating Patients With Malignant Melanoma

NCT00003897 | Completed Phase 1

• 5 other identifiers: CO98601U01CA061498NCI-T98-0045A536755SMPH/PEDIATRICS
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Melanoma (Skin)

Keywords

stage IV melanoma; recurrent melanoma

Interventions

gp100 antigen BIOLOGICAL

sargramostim BIOLOGICAL

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Wisconsin Comprehensive Cancer Center

Madison, Wisconsin, 53792, United States

Location

Related Links

• University of Wisconsin Carbone Cancer Center

MeSH Terms

Conditions

Melanoma

Interventions

sargramostim

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Mark R. Albertini, MD

  University of Wisconsin, Madison

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: August 18, 2004
• Study Start: May 1, 1999
• Primary Completion: March 1, 2001
• Study Completion: December 1, 2006
• Last Updated: November 19, 2019

Record last verified: 2015-07

Locations

US (1)