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

NCT ID: NCT00037037

Last Updated: 2013-12-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-10-31

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.

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.

Conditions

Melanoma (Skin)

Keywords

stage III melanoma; stage IV melanoma; recurrent melanoma

Study Design

• Allocation Method: RANDOMIZED
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

MAGE-10.A2

Intervention Type: BIOLOGICAL

MART-1 antigen

Intervention Type: BIOLOGICAL

NY-ESO-1 peptide vaccine

Intervention Type: BIOLOGICAL

sargramostim

Intervention Type: BIOLOGICAL

tyrosinase peptide

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Herbert Irving Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Principal Investigators

Kyriakos P. Papadopoulos, MD

Role: STUDY_CHAIR

Herbert Irving Comprehensive Cancer Center

Locations

Herbert Irving Comprehensive Cancer Center at Columbia University

New York, New York, United States

Countries

United States

Other Identifiers

CPMC-IRB-13824

Identifier Type: -

Identifier Source: secondary_id

LUDWIG-LUD00-025

Identifier Type: -

Identifier Source: secondary_id

NCI-G02-2068

Identifier Type: -

Identifier Source: secondary_id

CDR0000069357

Identifier Type: -

Identifier Source: org_study_id