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Vaccine Therapy With or Without Sargramostim in Treating Patients With High-Risk or Metastatic Melanoma
This study is ongoing, but not recruiting participants.
Sponsors and Collaborators: Herbert Irving Comprehensive Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00037037
  Purpose

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)
Drug: MAGE-10.A2
Drug: MART-1 antigen
Drug: NY-ESO-1 peptide vaccine
Drug: sargramostim
Drug: tyrosinase peptide
Phase I

MedlinePlus related topics: Cancer Melanoma
Drug Information available for: Sargramostim Granulocyte-macrophage colony-stimulating factor Tyrosinase
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control
Official Title: A Phase I Study of Peptide Based Vaccine Therapy in Patients With High-Risk or Metastatic Melanoma

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

Study Start Date: October 2001
Detailed Description:

OBJECTIVES:

  • 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • Karnofsky 80-100%

Life expectancy:

  • At least 4 months

Hematopoietic:

  • 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

Hepatic:

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

Renal:

  • Creatinine no greater than 1.8 mg/dL

Cardiovascular:

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

Other:

  • 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

PRIOR CONCURRENT THERAPY:

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

Chemotherapy:

  • 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

Radiotherapy:

  • At least 4 weeks since prior radiotherapy

Surgery:

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

Other:

  • 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00037037

Locations
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
Investigators
Study Chair: Kyriakos P. Papadopoulos, MD Herbert Irving 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: CDR0000069357, CPMC-IRB-13824, LUDWIG-LUD00-025, NCI-G02-2068
Study First Received: May 13, 2002
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00037037  
Health Authority: United States: Federal Government

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

Study placed in the following topic categories:
Neuroectodermal Tumors
Nevus, Pigmented
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma
Nevus
Recurrence
Neuroendocrine Tumors
Melanoma

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas

ClinicalTrials.gov processed this record on January 16, 2009