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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00077532
First received: February 10, 2004
Last updated: June 21, 2012
Last verified: June 2012
  Purpose

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.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: A Study of Intra-Patient Escalating Doses of MDX-010 Given Alone or in Combination With Two 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 Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • Objective response (partial and complete) [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety [ Designated as safety issue: Yes ]
  • Immune response activity [ Designated as safety issue: No ]

Estimated Enrollment: 179
Study Start Date: March 2004
Study Completion Date: February 2008
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
  Show Detailed Description

  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
  • 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)
  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: NCT00077532

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

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00077532     History of Changes
Obsolete Identifiers: NCT00076167
Other Study ID Numbers: 040083, 04-C-0083, MDX-010-19, NCI-6532, CDR0000352187
Study First Received: February 10, 2004
Last Updated: June 21, 2012
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
stage IV melanoma
recurrent melanoma

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

ClinicalTrials.gov processed this record on October 01, 2014