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Phase I Pilot Randomized Study of Melanoma Peptide Vaccine With or Without Sargramostim (GM-CSF) in Patients With High-Risk or Metastatic Melanoma
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
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Phase
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Type
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Status
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Age
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Sponsor
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Protocol IDs
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Phase I
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Treatment
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Closed
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18 and over
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NCI
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CPMC-IRB-13824 LUDWIG-LUD00-025, NCI-G02-2068, NCT00037037
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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.
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: Performance status: Life expectancy: 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) | | | |
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 |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol. Back to Top |
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