Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase I Treatment Closed 18 and over NCI CPMC-IRB-13824 LUDWIG-LUD00-025, NCI-G02-2068, NCT00037037

Objectives

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

Entry 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

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

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

Expected Enrollment

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

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.

Trial Contact Information

Trial Lead Organizations

Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center

Kyriakos Papadopoulos, MD, Protocol chair(Contact information may not be current)		Ph: 212-305-9327

Registry Information
Official Title		A Phase I Study of Peptide Based Vaccine Therapy in Patients with High-Risk or Metastatic Melanoma
Trial Start Date		2001-10-10
Registered in ClinicalTrials.gov		NCT00037037
Date Submitted to PDQ		2002-04-02
Information Last Verified		2004-05-07
NCI Grant/Contract Number		P30-CA13696