Monoclonal Antibody and Vaccine Therapy in Treating Patients With Stage III or Stage IV Melanoma That Has Been Removed During Surgery

NCT00025181 | Completed Phase 1 DMC

• 4 other identifiers: CDR0000068934 (10M-00-4)LAC-USC-10M004MDX-MDXCTLA4-03NCI-4210
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Vaccines made from a person's cancer cells may make the body build an immune response to kill tumor cells. PURPOSE: Phase I trial to study the effectiveness of combining monoclonal antibody therapy and vaccine therapy in treating patients who have stage III or stage IV melanoma that has been removed during surgery.

Conditions

Intraocular Melanoma; Melanoma (Skin)

Keywords

iris melanoma; ciliary body and choroid melanoma, small size; ciliary body and choroid melanoma, medium/large size; extraocular extension melanoma; recurrent intraocular melanoma; stage III melanoma; stage IV melanoma; recurrent melanoma

Interventions

MART-1 antigen BIOLOGICAL

gp100 antigen BIOLOGICAL

incomplete Freund's adjuvant BIOLOGICAL

ipilimumab BIOLOGICAL

tyrosinase peptide BIOLOGICAL

adjuvant therapy PROCEDURE

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed completely resected stage III or IV melanoma * Mucosal or ocular subtypes allowed * HLA-A2 positive * Positive staining of tumor tissue with antibody HMB-45 for gp100, tyrosinase, and/or MART-1 * Failed (or ineligible for or refusal of) interferon alfa PATIENT CHARACTERISTICS: Age: * Not specified Performance status: * Karnofsky 60-100% Life expectancy: * At least 12 months Hematopoietic: * WBC at least 2,500/mm\^3 * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 * Hemoglobin at least 10 g/dL * Hematocrit at least 30% Hepatic: * Bilirubin no greater than upper limit of normal (ULN) * AST no greater than 1.25 times ULN * Hepatitis B surface antigen negative * Hepatitis C antibody nonreactive Renal: * Creatinine less than 1.25 times ULN Immunologic: * Antinuclear antibody (ANA) negative OR * If ANA positive, must be: * Antithyroglobulin antibody negative * Rheumatoid factor negative * Anti-LKM antibody negative * Anti-phospholipid antibody negative * Anti-islet cell antibody negative * Anti-neutrophil cytoplasmic antibody negative * HIV negative * No autoimmune disease (e.g., uveitis or autoimmune inflammatory eye disease) * No active infection * No hypersensitivity to tyrosinase:368-376, gp100:209-217, MART-1:26-35, or Montanide ISA-51 Other: * No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix * No underlying medical condition that would preclude study * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * See Disease Characteristics * No prior anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody * No prior tyrosinase, gp100, or MART-1 peptide * No prior antitumor vaccination * No prior interleukin-2 * At least 4 weeks since prior immunotherapy for melanoma Chemotherapy: * At least 4 weeks since prior chemotherapy for melanoma Endocrine therapy: * At least 4 weeks since prior hormonal therapy for melanoma * At least 4 weeks since prior corticosteroids * No concurrent systemic or topical corticosteroids Radiotherapy: * At least 4 weeks since prior radiotherapy for melanoma Surgery: * See Disease Characteristics Other: * No prior cytotoxic therapy * At least 4 weeks since any other prior therapy for melanoma * Concurrent analgesics allowed if on stable dose for at least 2 weeks before study

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

Sponsors & Collaborators

• University of Southern California: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

USC/Norris Comprehensive Cancer Center and Hospital

Los Angeles, California, 90089, United States

Location

MeSH Terms

Conditions

Uveal Melanoma; Melanoma

Interventions

MART-1 Antigen; incomplete Freund's adjuvant; Ipilimumab; Chemotherapy, Adjuvant

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Melanoma-Specific Antigens; Neoplasm Proteins; Proteins; Amino Acids, Peptides, and Proteins; Antigens, Neoplasm; Antigens; Biological Factors; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Combined Modality Therapy; Therapeutics; Drug Therapy

Study Officials

• Jeffrey S. Weber, MD, PhD

  University of Southern California

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: October 11, 2001
• First Posted: January 27, 2003
• Study Start: October 1, 2001
• Primary Completion: January 1, 2003
• Study Completion: June 1, 2005
• Last Updated: May 22, 2014

Record last verified: 2014-05

Locations

US (1)