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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2004 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI) Identifier:
First received: May 13, 2002
Last updated: December 17, 2013
Last verified: May 2004

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

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

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

Study Start Date: October 2001
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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
  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 identifier: NCT00037037

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)
Study Chair: Kyriakos P. Papadopoulos, MD Herbert Irving Comprehensive Cancer Center
  More Information Identifier: NCT00037037     History of Changes
Other Study ID Numbers: CDR0000069357
Study First Received: May 13, 2002
Last Updated: December 17, 2013

Keywords provided by National Cancer Institute (NCI):
stage III melanoma
stage IV melanoma
recurrent melanoma

Additional relevant MeSH terms:
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 processed this record on August 21, 2017