Vaccine Therapy With or Without Sargramostim in Treating Patients With High-Risk or Metastatic Melanoma
Recruitment status was Active, not recruiting
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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 |
| Study Start Date: | October 2001 |
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 |
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| United States, New York | |
| Herbert Irving Comprehensive Cancer Center at Columbia University | |
| New York, New York, United States, 10032 | |
| 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: | February 6, 2009 |
| 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 Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal |
Neoplasms by Histologic Type Neoplasms Neoplasms, Nerve Tissue Nevi and Melanomas |
ClinicalTrials.gov processed this record on June 17, 2013