Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Peptide Vaccine, Montanide ISA 51 and ISA 51 VG, and CpG 7909 in Treating Patients With Resected Stage IIC, Stage III, or Stage IV Melanoma
This study has been completed.
Sponsors and Collaborators: Norris Comprehensive Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00085189
  Purpose

RATIONALE: Vaccines made from peptides may make the body build an immune response to kill tumor cells. Combining a vaccine with Montanide ISA-51 and ISA 51 VG and CpG 7909 may cause a stronger immune response and kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving peptide vaccine together with Montanide ISA 51 and ISA 51 VG and CpG 7909 works in treating patients with stage IIC, stage III, or stage IV melanoma that has been completely resected.


Condition Intervention Phase
Intraocular Melanoma
Melanoma (Skin)
Drug: agatolimod sodium
Drug: gp100 antigen
Drug: incomplete Freund's adjuvant
Drug: recombinant MAGE-3.1 antigen
Drug: tyrosinase peptide
Procedure: adjuvant therapy
Phase II

Genetics Home Reference related topics: retinoblastoma
MedlinePlus related topics: Cancer Melanoma
Drug Information available for: Tyrosinase Freund's adjuvant Montanide ISA 51 Agatolimod sodium
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment
Official Title: A Phase II Trial of a Vaccine Combining Multiple Class I Peptides With Montanide ISA 51 and ISA 51 VG and CpG Adjuvant 7909 for Patients With Resected Stages IIC/III and IV Melanoma

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

Primary Outcome Measures:
  • Immunological response as measured by ELISPOT assy, tetramer assay, and chromium release assay [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Toxicity [ Designated as safety issue: Yes ]
  • Time to relapse [ Designated as safety issue: No ]

Study Start Date: May 2004
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • Determine the safety and tolerability of a multipeptide (gp100 antigen, MAGE-3, and tyrosinase peptide) melanoma vaccine, Montanide ISA 51 and ISA 51 VG, and CpG 7909 in patients with resected stage IIC, III, or IV melanoma.
  • Determine the immune reactivity of this regimen in these patients.

OUTLINE: This is a pilot study. Patients are stratified according to class I haplotype (HLA-A1 vs HLA-A3/A11).

Patients receive gp100 antigen, MAGE-3, tyrosinase peptide, Montanide ISA 51 and ISA 51 VG, and CpG 7909 subcutaneously on weeks 0, 2, 4, 6, 8, 10, 14, 18, 22, 26, 38, 50, and then every 6 months for 2 years (for a total of 16 vaccinations) in the absence of unacceptable toxicity.

Patients are followed every 6 months for 3 years and then annually thereafter.

PROJECTED ACCRUAL: A total of 42 patients (21 per stratum) will be accrued for this study within 1-2 years.

  Eligibility

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

DISEASE CHARACTERISTICS:

  • Diagnosis of melanoma

    • Stage IIC, III, or IV cutaneous or mucosal disease
    • Stage III or IV ocular disease
    • Completely resected disease
  • Disease-free within the past year after radiotherapy or systemic chemotherapy and/or immunotherapy
  • Must be HLA-A1 or -A3/A11 positive by standard DNA-polymerase chain reaction assay AND HLA-B44 status known

    • Patients who are B44-positive but do not express A1, A3, or A11 are not eligible
  • Positive for gp100 and/or tyrosinase antigen by immunohistochemistry
  • Meets 1 of the following conditions for interferon alfa (IFN-α) therapy:

    • Failed prior IFN-α therapy
    • IFN-α contraindicated due to pre-existing medical or psychiatric condition
    • Refused IFN-α treatment

PATIENT CHARACTERISTICS:

Age

  • 16 and over

Performance status

  • ECOG 0-1

Life expectancy

  • Not specified

Hematopoietic

  • Granulocyte count ≥ 1,500/mm^3
  • WBC ≥ 3,000/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Hemoglobin ≥ 9.0 g/dL
  • No coagulation or bleeding disorders

Hepatic

  • SGOT and SGPT ≤ 2.5 times normal
  • Bilirubin ≤ 2.0 mg/dL
  • Hepatitis B surface antigen negative
  • Hepatitis C antibody negative

Renal

  • Creatinine ≤ 2.0 mg/dL

Cardiovascular

  • No major medical illness of the cardiovascular system

Pulmonary

  • No pneumonia
  • No other major medical illness of the respiratory system

Immunologic

  • HIV negative
  • No sepsis
  • No history of uveitis
  • No major systemic infection
  • No known allergic reaction to Montanide ISA 51 and ISA 51 VG
  • No autoimmune inflammatory eye disease
  • No other autoimmune disease except vitiligo or controlled thyroiditis

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No major medical illness of the gastrointestinal system
  • No other malignancy within the past 3 years except curatively treated squamous cell or basal cell skin cancer or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • See Disease Characteristics
  • No prior gp100 antigen, MAGE-3, or tyrosinase peptide

Chemotherapy

  • See Disease Characteristics
  • More than 6 weeks since prior nitrosoureas

Endocrine therapy

  • More than 4 weeks since prior steroid therapy
  • No concurrent steroid therapy

Radiotherapy

  • See Disease Characteristics
  • More than 1 month since prior radiotherapy

Surgery

  • See Disease Characteristics

Other

  • More than 1 month since prior anticancer therapy
  • More than 1 month since prior adjuvant therapy
  • No other concurrent anticancer therapy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00085189

Locations
United States, California
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States, 90089
Sponsors and Collaborators
Norris Comprehensive Cancer Center
Investigators
Principal Investigator: Jeffrey S. Weber, MD, PhD Norris Comprehensive Cancer Center
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000367485, LAC-USC-10M033, LAC-USC-IRB-942010, NCI-6451
Study First Received: June 10, 2004
Last Updated: December 6, 2008
ClinicalTrials.gov Identifier: NCT00085189  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage II melanoma
stage III melanoma
stage IV melanoma
iris melanoma
ciliary body and choroid melanoma, medium/large size
extraocular extension melanoma

Study placed in the following topic categories:
Eye Neoplasms
Eye Diseases
Melanoma
Neuroendocrine Tumors
Melanoma of the choroid
Neuroectodermal Tumors
Uveal melanoma
Neoplasms, Germ Cell and Embryonal
Nevus, Pigmented
Intraocular melanoma
Neuroepithelioma
Freund's Adjuvant
Nevus

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Immunologic Factors
Physiological Effects of Drugs
Neoplasms, Nerve Tissue
Adjuvants, Immunologic
Nevi and Melanomas
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009