Vaccine Therapy and Monoclonal Antibody Therapy in Treating Patients With Stage IV Melanoma
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ClinicalTrials.gov Identifier: NCT00032045 |
Recruitment Status :
Completed
First Posted : January 27, 2003
Last Update Posted : June 20, 2013
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Intraocular Melanoma Melanoma (Skin) | Biological: gp100 antigen Biological: incomplete Freund's adjuvant Biological: ipilimumab | Phase 2 |
OBJECTIVES:
- Determine the clinical response in patients with stage IV melanoma when treated with anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody combined with gp100:209-217 and gp100:280-288 peptides emulsified in Montanide ISA-51.
- Determine a safety and adverse event profile of this regimen in these patients.
- Determine improved immunologic response in patients treated with this regimen.
OUTLINE: This is an open-label study.
Patients receive anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody IV over 90 minutes immediately followed by gp100:209-217 and gp100:280-288 peptides emulsified in Montanide ISA-51 subcutaneously on days 1, 22, 43, and 64. Treatment repeats every 12 weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed at 3 weeks, every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 68 patients will be accrued for this study within 2 years.
Study Type : | Interventional (Clinical Trial) |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | An Open-label Study Of MDX-010 In Combination With gp100 Peptides Emulsified With Montanide ISA 51 In The Treatment Of Patients With Stage IV Melanoma |
Study Start Date : | January 2002 |
Actual Study Completion Date : | August 2006 |


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Ages Eligible for Study: | 16 Years and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00032045
United States, Maryland | |
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support | |
Bethesda, Maryland, United States, 20892-1182 |
Study Chair: | Steven A. Rosenberg, MD, PhD | NCI - Surgery Branch |
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: | NCT00032045 |
Obsolete Identifiers: | NCT00029549 |
Other Study ID Numbers: |
CDR0000069251 NCI-02-C-0106H NCI-5743 |
First Posted: | January 27, 2003 Key Record Dates |
Last Update Posted: | June 20, 2013 |
Last Verified: | March 2003 |
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 |
Melanoma Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Nerve Tissue Nevi and Melanomas Ipilimumab |
Freund's Adjuvant Antineoplastic Agents, Immunological Antineoplastic Agents Immune Checkpoint Inhibitors Molecular Mechanisms of Pharmacological Action Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs |