Monoclonal Antibody With or Without gp100 Peptides Plus Montanide ISA-51 in Treating Patients With Stage IV Melanoma

NCT00077532 | Completed Phase 2

• 5 other identifiers: 04008304-C-0083MDX-010-19NCI-6532CDR0000352187
• Study Type: interventional
• Target: 179
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Biological therapies, such as MDX-010, work in different ways to stimulate the immune system and stop tumor cells from growing. Vaccines made from gp100 peptides may make the body build an immune response to kill tumor cells. Combining the vaccines with Montanide ISA-51 may cause a stronger immune response and kill more tumor cells. It is not yet known whether monoclonal antibody therapy is more effective with or without vaccine therapy in treating advanced melanoma. PURPOSE: This randomized phase II trial is studying monoclonal antibody therapy alone to see how well it works compared to monoclonal antibody therapy, gp100 peptides, and Montanide ISA-51 in treating patients with stage IV melanoma.

Conditions

Melanoma (Skin)

Keywords

stage IV melanoma; recurrent melanoma

Outcome Measures

Primary Outcomes (1)

• Objective response (partial and complete)

Secondary Outcomes (2)

• Safety

• Immune response activity

Interventions

gp100 antigen BIOLOGICAL

incomplete Freund's adjuvant BIOLOGICAL

ipilimumab BIOLOGICAL

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed stage IV melanoma * Clinically evaluable or measurable disease * No mucosal or ocular melanoma PATIENT CHARACTERISTICS: Age * 16 and over Performance status * ECOG 0-2 Life expectancy * At least 6 months Hematopoietic * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Hemoglobin ≥ 9 g/dL * Hematocrit ≥ 28% * WBC ≥ 2,500/mm\^3 Hepatic * AST ≤ 3 times upper limit of normal (ULN) * Bilirubin ≤ ULN (\< 3 mg/dL for patients with Gilbert's syndrome) * Hepatitis B surface antigen negative * Hepatitis C virus antibody negative Renal * Creatinine \< 2 mg/dL Immunologic * HIV negative * No history of any of the following: * Inflammatory bowel disease * Regional enteritis * Connective tissue disorders (e.g., systemic lupus erythematosus) * Rheumatoid arthritis * Autoimmune inflammatory eye disease * Sjögren's syndrome * Inflammatory neurologic disorder (e.g., multiple sclerosis) * No active infection * No active autoimmune disease that may cause life-threatening symptoms or severe organ/tissue damage * Vitiligo, autoimmune thyroiditis, or skin rashes associated with prior therapy are allowed if patient has recovered to grade 1 or less toxicity * No systemic hypersensitivity to study agents * Prior local reaction (e.g., delayed hypersensitivity or glaucomatous reactions) to Montanide ISA-51 or gp100 injections allowed * No autoimmune disease requiring active therapy with any form of steroid or immunosuppressant Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No concurrent underlying medical condition that would preclude study participation * 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 PRIOR CONCURRENT THERAPY: Biologic therapy * No prior anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody * Prior therapy with gp100 peptides or any other immunotherapy allowed Chemotherapy * At least 6 weeks since prior nitrosoureas and recovered (toxicity no greater than grade 1) * No concurrent chemotherapy Endocrine therapy * At least 4 weeks since prior steroids * No concurrent systemic, inhaled, optical, or topical corticosteroids Radiotherapy * Not specified Surgery * Not specified Other * At least 3 weeks since prior systemic therapy for melanoma and recovered (toxicity no greater than grade 1) * No concurrent immunosuppressive agents (e.g., cyclosporine)

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

Sponsors & Collaborators

• National Institutes of Health Clinical Center (CC): lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Bethesda, Maryland, 20892-1182, United States

Location

Related Publications (1)

• Schadendorf D, Hodi FS, Robert C, Weber JS, Margolin K, Hamid O, Patt D, Chen TT, Berman DM, Wolchok JD. Pooled Analysis of Long-Term Survival Data From Phase II and Phase III Trials of Ipilimumab in Unresectable or Metastatic Melanoma. J Clin Oncol. 2015 Jun 10;33(17):1889-94. doi: 10.1200/JCO.2014.56.2736. Epub 2015 Feb 9.

  PMID: 25667295 DERIVED

MeSH Terms

Conditions

Melanoma

Interventions

incomplete Freund's adjuvant; Ipilimumab

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

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Steven A. Rosenberg, MD, PhD

  NCI - Surgery Branch

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: February 10, 2004
• First Posted: February 12, 2004
• Study Start: March 1, 2004
• Primary Completion: January 1, 2007
• Study Completion: February 1, 2008
• Last Updated: June 22, 2012

Record last verified: 2012-06

Locations

US (1)