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Vaccine Therapy With or Without Sargramostim in Treating Patients With High-Risk or Metastatic Melanoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00037037
Recruitment Status : Unknown
Verified May 2004 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : January 27, 2003
Last Update Posted : December 18, 2013
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Vaccines made from peptides may make the body build an immune response to kill tumor cells. Colony-stimulating factors such as sargramostim may increase the number of immune cells found in bone marrow or peripheral blood. Combining vaccine therapy with sargramostim may kill more tumor cells.

PURPOSE: Randomized phase I trial to study the effectiveness of vaccine therapy with or without sargramostim in treating patients who have metastatic melanoma.

Condition or disease Intervention/treatment Phase
Melanoma (Skin) Biological: MAGE-10.A2 Biological: MART-1 antigen Biological: NY-ESO-1 peptide vaccine Biological: sargramostim Biological: tyrosinase peptide Phase 1

Detailed Description:


  • Compare the safety of melanoma peptide vaccine with or without sargramostim (GM-CSF) in patients with high-risk or metastatic melanoma.
  • Compare changes in peptide-specific cellular and humoral immunologic profiles in patients treated with these regimens.
  • Compare tumor response in patients treated with these regimens.

OUTLINE: This is a randomized, open-label study. Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive melanoma peptide vaccine comprising tyrosinase leader injected at 2 separate sites, Melan-A ELA injected at another site, NY-ESO-1a and NY-ESO-1b combined and injected at one site, and MAGE-10.A2 injected at another site, intradermally once weekly on weeks 1-6.
  • Arm II: Patients receive vaccine as in arm I. Patients also receive sargramostim (GM-CSF) subcutaneously daily beginning 2 days before each vaccination and continuing for 5 days.

Treatment in both arms continues through week 6 in the absence of disease progression or unacceptable toxicity.

Patients are followed at 2 weeks.

PROJECTED ACCRUAL: A total of 20 patients (10 per treatment arm) will be accrued for this study within 18 months.

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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Study of Peptide Based Vaccine Therapy in Patients With High-Risk or Metastatic Melanoma
Study Start Date : October 2001

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed high-risk stage III or IV melanoma

    • Stage III disease less than 6 months after surgical resection

      • Completed prior interferon alfa therapy OR
      • Progressive disease or major adverse events during prior interferon alfa therapy
    • Stage III disease at least 6 months after surgical resection

      • Declined, failed, or completed prior standard therapy
    • Stage IV disease

      • Declined, failed, or completed prior standard therapy
  • HLA-A2 positive
  • No CNS metastases unless treated and stable



  • 18 and over

Performance status:

  • Karnofsky 80-100%

Life expectancy:

  • At least 4 months


  • Neutrophil count at least 1,500/mm3
  • Lymphocyte count at least 500/mm3
  • Platelet count at least 100,000/mm3
  • Hemoglobin at least 9.0 g/dL (10.0 g/dL if less than 50 kg)
  • No bleeding disorder


  • Bilirubin no greater than 2.0 mg/dL
  • No hepatitis B or C positivity


  • Creatinine no greater than 1.8 mg/dL


  • No New York Heart Association class III or IV heart disease


  • HIV negative
  • No other serious illness
  • No serious infection requiring antibiotics
  • No history of immunodeficiency disease or autoimmune disease
  • No psychiatric or addictive disorder that would preclude study
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception


Biologic therapy:

  • See Disease Characteristics
  • No prior bone marrow or stem cell transplantation
  • At least 4 weeks since prior immunotherapy or biologic therapy
  • No other concurrent immunotherapy or biologic therapy


  • At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas)
  • No concurrent chemotherapy

Endocrine therapy:

  • No concurrent systemic corticosteroids
  • No concurrent steroids except topical or inhalational steroids
  • Concurrent hormonal therapy allowed


  • At least 4 weeks since prior radiotherapy


  • See Disease Characteristics
  • At least 4 weeks since prior surgery


  • At least 4 weeks since prior investigational agents
  • Concurrent noncytotoxic anticancer therapy allowed
  • No concurrent immunosuppressive therapy
  • No concurrent antihistamines
  • No concurrent non-steroidal anti-inflammatory drugs except in low doses for prevention of an acute cardiovascular event or pain control

Information from the National Library of Medicine

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 identifier (NCT number): NCT00037037

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United States, New York
Herbert Irving Comprehensive Cancer Center at Columbia University
New York, New York, United States, 10032
Sponsors and Collaborators
Herbert Irving Comprehensive Cancer Center
National Cancer Institute (NCI)
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Study Chair: Kyriakos P. Papadopoulos, MD Herbert Irving Comprehensive Cancer Center

Layout table for additonal information Identifier: NCT00037037    
Other Study ID Numbers: CDR0000069357
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: December 18, 2013
Last Verified: May 2004
Keywords provided by National Cancer Institute (NCI):
stage III melanoma
stage IV melanoma
recurrent melanoma
Additional relevant MeSH terms:
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Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Immunologic Factors
Physiological Effects of Drugs