Vaccine Therapy With or Without Sargramostim in Treating Patients With High-Risk or Metastatic Melanoma
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
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.
Study Design
Outcome Measures
Primary Outcome Measures
Eligibility Criteria
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | 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)
Investigators
- Study Chair: Kyriakos P. Papadopoulos, MD, Herbert Irving Comprehensive Cancer Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CDR0000069357
- CPMC-IRB-13824
- LUDWIG-LUD00-025
- NCI-G02-2068