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

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00032045
First received: March 8, 2002
Last updated: June 18, 2013
Last verified: March 2003
  Purpose

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 Intervention Phase
Intraocular Melanoma
Melanoma (Skin)
Biological: gp100 antigen
Biological: incomplete Freund's adjuvant
Biological: ipilimumab
Phase 2

Study Type: Interventional
Study Design: Masking: 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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: January 2002
Study Completion Date: August 2006
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00032045

Locations
United States, Maryland
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, United States, 20892-1182
Sponsors and Collaborators
Investigators
Study Chair: Steven A. Rosenberg, MD, PhD NCI - Surgery Branch
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00032045     History of Changes
Obsolete Identifiers: NCT00029549
Other Study ID Numbers: CDR0000069251, NCI-02-C-0106H, NCI-5743
Study First Received: March 8, 2002
Last Updated: June 18, 2013
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
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

Additional relevant MeSH terms:
Melanoma
Uveal Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Eye Neoplasms
Neoplasms by Site
Eye Diseases
Uveal Diseases
Antibodies, Monoclonal
Freund's Adjuvant
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Adjuvants, Immunologic

ClinicalTrials.gov processed this record on August 27, 2014