Vaccine Therapy Plus Immune Adjuvants in Treating Patients With Advanced Melanoma

NCT00003362 | Completed Phase 2

• 3 other identifiers: 98-012CDR0000066345NCI-T97-0110
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Vaccines made from peptides that are found on melanoma cells may make the body build an immune response and kill melanoma cells. Combining vaccine therapy with immune adjuvants, such as GM-CSF, Montanide ISA-51, or QS21, may be a more effective treatment for advanced melanoma. PURPOSE: Randomized phase II trial to study the effectiveness of gp 100-tyrosinase peptide vaccine with one of the immune adjuvants GM-CSF, Montanide ISA-51, or QS21 in treating patients who have stage III or stage IV melanoma.

Conditions

Melanoma (Skin)

Keywords

stage III melanoma; stage IV melanoma; recurrent melanoma

Interventions

QS21 BIOLOGICAL

gp100 antigen BIOLOGICAL

incomplete Freund's adjuvant BIOLOGICAL

sargramostim BIOLOGICAL

tyrosinase peptide BIOLOGICAL

Eligibility Criteria

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

DISEASE CHARACTERISTICS: Histologically confirmed unresectable stage III or stage IV melanoma Patients who are disease free following surgical resection or chemotherapy for stage III or IV disease also eligible HLA-A201 positive PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: At least 5 months Hematopoietic: WBC at least 3,500/mm3 Platelet count at least 75,000/mm3 LDH no greater than 2 times upper limit of normal No active bleeding Hepatic: Albumin at least 3.5 mg/dL Renal: Not specified Other: Not pregnant or less than 3 months postpartum Fertile patients must use effective contraception No serious underlying medical conditions No known immunodeficiency No active infection No retinal or choroidal eye disease PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior immunotherapy and recovered No prior tyrosinase or gp100 peptides No prior Montanide ISA-51 No prior melanoma protein vaccine or melanoma whole cell vaccines No other concurrent immunotherapy Chemotherapy: At least 4 weeks since prior chemotherapy and recovered No concurrent chemotherapy Endocrine therapy: At least 2 weeks since prior systemic steroids and recovered No concurrent systemic steroids Radiotherapy: At least 4 weeks since prior radiotherapy and recovered No prior radiotherapy to the spleen No concurrent radiotherapy Surgery: Recovered from any prior surgery No prior splenectomy Other: At least 1 week since prior antiinflammatory drugs and recovered At least 1 week since prior antihistamines and recovered No concurrent antiinflammatory drugs No concurrent antihistamines No concurrent antimicrobial drugs

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

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Melanoma

Interventions

saponin QA-21V1; incomplete Freund's adjuvant; 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

• Paul B. Chapman, MD

  Memorial Sloan Kettering Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: August 26, 2004
• Study Start: May 1, 1998
• Primary Completion: February 1, 2001
• Study Completion: February 1, 2001
• Last Updated: June 25, 2013

Record last verified: 2013-06

Locations

US (1)