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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2004 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00037037
First received: May 13, 2002
Last updated: December 17, 2013
Last verified: May 2004
  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)
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: 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:

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
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: 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

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00037037     History of Changes
Other Study ID Numbers: CDR0000069357, CPMC-IRB-13824, LUDWIG-LUD00-025, NCI-G02-2068
Study First Received: May 13, 2002
Last Updated: December 17, 2013
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Melanoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Neuroectodermal Tumors
Neuroendocrine Tumors
Nevi and Melanomas

ClinicalTrials.gov processed this record on October 29, 2014