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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00470379 |
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Date of registration:
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03/05/2007 |
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Primary sponsor: |
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Public title:
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Vaccine Therapy and Resiquimod in Treating Patients With Stage II, Stage III, or Stage IV Melanoma That Has Been Completely Removed by Surgery
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Scientific title:
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Transcutaneous (Topical) Peptide Immunization With NY-ESO-1b (SLLMWITQC) Peptide Using Resiquimod as an Immune Adjuvant: A Pilot Study |
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Date of first enrolment:
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April 2006 |
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Target sample size:
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30 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00470379 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Svetomir Markovic, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Mayo Clinic |
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Key inclusion & exclusion criteria
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DISEASE CHARACTERISTICS:
- Prior diagnosis of melanoma meeting the following criteria:
- Stage II-IV disease
- Complete resection of disease
- No current evidence of disease
- HLA-A2 positive
- No known standard therapy for disease that is potentially curative or proven capable
of extending life expectancy exists
PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Hemoglobin = 9.0 g/dL
- Platelet count = 75,000/mm³
- AST = 3 times upper limit of normal
- No uncontrolled or current infection
- No known allergy to vaccine or adjuvant components
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No known immune deficiency
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- More than 4 weeks since prior chemotherapy and recovered
- More than 4 weeks since prior biologic therapy
- No concurrent immunosuppressive therapy
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Melanoma (Skin)
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Intervention(s)
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Drug: resiquimod
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Primary Outcome(s)
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Number and severity of hematologic and non-hematologic toxicities
[Time Frame: 4 weeks]
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Percent of patients who mount an immune response
[Time Frame: 4 weeks]
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Toxicity profile of each dose level
[Time Frame: 4 weeks]
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Secondary ID(s)
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169-06
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MC0578
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P30CA015083
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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