Ipilimumab With or Without Vaccine Therapy in Treating Patients With Previously Treated Stage IV Melanoma

NCT00357461 | Withdrawn Phase 2

• 4 other identifiers: CDR0000486705NCI-06-C-0159NCI-P6951MDX-NCI-06-C-0159
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

RATIONALE: Monoclonal antibodies, such as ipilimumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Vaccines made from gp100 peptides may help the body build an effective immune response to kill tumor cells. Giving ipilimumab together with vaccine therapy may be an effective treatment for melanoma. PURPOSE: This randomized phase II trial is studying ipilimumab and vaccine therapy to see how well they work compared to ipilimumab alone in treating patients with previously treated stage IV melanoma.

Conditions

Melanoma (Skin)

Keywords

stage IV melanoma; recurrent melanoma

Outcome Measures

Primary Outcomes (1)

• Clinical response

Secondary Outcomes (4)

• Safety and toxicity

• Immunologic response

• Response rate

• Overall survival

Interventions

gp100:209-217(210M) peptide vaccine BIOLOGICAL

gp100:280-288(288V) peptide vaccine 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 * HLA-A\*0201 positive disease * Previously treated metastatic disease * Clinically evaluable and measurable disease * No mucosal or ocular melanoma * No evidence of active brain metastases PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * WBC ≥ 2,500/mm³ * Absolute neutrophil count ≥ 1,000/mm³ * Absolute lymphocyte count ≥ 500/mm³ * Platelet count ≥ 75,000/mm³ * Hemoglobin ≥ 9 g/dL * Creatinine \< 2.5 mg/dL * AST ≤ 2 times upper limit of normal (ULN) (5 times ULN if liver metastases are present) * Bilirubin normal (\< 3.0 mg/dL if Gilbert's syndrome is present) * Hepatitis B surface antigen negative * HIV negativity * No hepatitis C virus antibodies * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No other prior malignancy except for any of the following: * Adequately treated basal cell or squamous cell skin cancer * Superficial bladder cancer * Carcinoma in situ of the cervix * Any other cancer from which patient has been disease free for \> 5 years * No active immune-mediated disease requiring active therapy with any form of steroid or immunosuppressive therapy * No documented history of any of the following: * Inflammatory bowel disease * Regional enteritis * Connective tissue disorders, such as systemic lupus erythematosus * Rheumatoid arthritis * Immune-mediated inflammatory eye disease * Sjögren's syndrome * Inflammatory neurologic disorder, such as multiple sclerosis * Any immune-mediated disease that can cause life-threatening symptoms or severe organ/tissue damage, in the opinion of the principal investigator * History of vitiligo or immune-mediated thyroiditis allowed * Skin rashes associated with previous therapy allowed provided patient has recovered from treatment-related toxicity to \< grade 1 * No active infection * No systemic hypersensitivity to any of the study drugs * History of local reactions (e.g., delayed hypersensitivity or glaucomatous reactions) to Montanide ISA-51 allowed * No underlying medical condition that, in the opinion of the investigator, would preclude study treatment PRIOR CONCURRENT THERAPY: * At least 3 weeks since prior systemic treatment (6 weeks for nitrosoureas) and recovered * No prior ipilimumab or gp100 vaccines * More than 4 weeks since prior steroids * No concurrent systemic or topical corticosteroids or immunosuppressive agents (e.g., cyclosporine or chemotherapy agents), including steroid enemas, inhaled steroids, or steroid eye drops * Hormone-replacement therapy allowed

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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead
• National Cancer Institute (NCI): collaborator

Related Publications (1)

• Downey SG, Klapper JA, Smith FO, Yang JC, Sherry RM, Royal RE, Kammula US, Hughes MS, Allen TE, Levy CL, Yellin M, Nichol G, White DE, Steinberg SM, Rosenberg SA. Prognostic factors related to clinical response in patients with metastatic melanoma treated by CTL-associated antigen-4 blockade. Clin Cancer Res. 2007 Nov 15;13(22 Pt 1):6681-8. doi: 10.1158/1078-0432.CCR-07-0187. Epub 2007 Nov 2.

  PMID: 17982122 BACKGROUND

MeSH Terms

Conditions

Melanoma

Interventions

Protein Subunit Vaccines; 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)

Vaccines, Acellular; Vaccines, Subunit; Vaccines; Biological Products; Complex Mixtures; 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
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 26, 2006
• First Posted: July 27, 2006
• Study Start: May 1, 2006
• Last Updated: May 15, 2013

Record last verified: 2013-05