Vaccine Therapy and Monoclonal Antibody Therapy in Treating Patients With Stage IV Melanoma

NCT00032045 | Completed Phase 2

• 3 other identifiers: CDR0000069251NCI-02-C-0106HNCI-5743
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Vaccines made from peptides may make the body build an immune response to kill tumor cells. Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining vaccine therapy with a monoclonal antibody may cause a stronger immune response and kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining vaccine therapy with monoclonal antibody therapy in treating patients who have stage IV melanoma.

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 IV melanoma; recurrent melanoma

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 * Mucosal or ocular melanoma allowed * Clinically evaluable disease * HLA-A\*0201 positive PATIENT CHARACTERISTICS: Age: * 16 and over Performance status: * Karnofsky 60-100% Life expectancy: * At least 6 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: * AST no greater than 3 times upper limit of normal (ULN) * Bilirubin no greater than ULN (less than 3.0 mg/dL in patients with Gilbert's syndrome) * Hepatitis B surface antigen negative * Hepatitis C antibody nonreactive Renal: * Creatinine less than 2.0 mg/dL Immunologic: * Antinuclear antibody negative * Thyroglobulin antibody normal * Rheumatoid factor normal * HIV negative * No prior autoimmune disease (including uveitis and autoimmune inflammatory eye disease) * No active infection * No hypersensitivity to Montanide ISA-51 Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * 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 other underlying medical condition that would preclude study therapy PRIOR CONCURRENT THERAPY: Biologic therapy: * At least 3 weeks since prior immunotherapy for melanoma and recovered * No prior gp100 peptides * No prior anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody Chemotherapy: * At least 3 weeks since prior chemotherapy for melanoma and recovered * No concurrent chemotherapy Endocrine therapy: * At least 3 weeks since prior hormonal therapy for melanoma and recovered * At least 4 weeks since prior systemic or topical corticosteroids * No concurrent topical or systemic corticosteroids Radiotherapy: * At least 3 weeks since prior radiotherapy for melanoma and recovered Surgery: * Not specified Other: * No other concurrent immunosuppressive agents (e.g., cyclosporine and its analog)

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

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Bethesda, Maryland, 20892-1182, United States

Location

Related Publications (5)

• Maker AV, Attia P, Rosenberg SA. Analysis of the cellular mechanism of antitumor responses and autoimmunity in patients treated with CTLA-4 blockade. J Immunol. 2005 Dec 1;175(11):7746-54. doi: 10.4049/jimmunol.175.11.7746.

  PMID: 16301685 BACKGROUND

• Maker AV, Phan GQ, Attia P, Yang JC, Sherry RM, Topalian SL, Kammula US, Royal RE, Haworth LR, Levy C, Kleiner D, Mavroukakis SA, Yellin M, Rosenberg SA. Tumor regression and autoimmunity in patients treated with cytotoxic T lymphocyte-associated antigen 4 blockade and interleukin 2: a phase I/II study. Ann Surg Oncol. 2005 Dec;12(12):1005-16. doi: 10.1245/ASO.2005.03.536. Epub 2005 Oct 21.

  PMID: 16283570 BACKGROUND

• Attia P, Phan GQ, Maker AV, Robinson MR, Quezado MM, Yang JC, Sherry RM, Topalian SL, Kammula US, Royal RE, Restifo NP, Haworth LR, Levy C, Mavroukakis SA, Nichol G, Yellin MJ, Rosenberg SA. Autoimmunity correlates with tumor regression in patients with metastatic melanoma treated with anti-cytotoxic T-lymphocyte antigen-4. J Clin Oncol. 2005 Sep 1;23(25):6043-53. doi: 10.1200/JCO.2005.06.205. Epub 2005 Aug 8.

  PMID: 16087944 RESULT

• Phan GQ, Yang JC, Sherry RM, Hwu P, Topalian SL, Schwartzentruber DJ, Restifo NP, Haworth LR, Seipp CA, Freezer LJ, Morton KE, Mavroukakis SA, Duray PH, Steinberg SM, Allison JP, Davis TA, Rosenberg SA. Cancer regression and autoimmunity induced by cytotoxic T lymphocyte-associated antigen 4 blockade in patients with metastatic melanoma. Proc Natl Acad Sci U S A. 2003 Jul 8;100(14):8372-7. doi: 10.1073/pnas.1533209100. Epub 2003 Jun 25.

  PMID: 12826605 RESULT

• 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

Uveal Melanoma; 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; Uveal Neoplasms; Eye Neoplasms; Neoplasms by Site; Eye Diseases; Uveal Diseases; Skin Neoplasms; 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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: March 8, 2002
• First Posted: January 27, 2003
• Study Start: January 1, 2002
• Study Completion: August 1, 2006
• Last Updated: June 20, 2013

Record last verified: 2003-03

Locations

US (1)