Vaccine Therapy in Treating Patients With Stage III or Stage IV Melanoma That Cannot Be Removed By Surgery
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|ClinicalTrials.gov Identifier: NCT00089206|
Recruitment Status : Completed
First Posted : August 5, 2004
Last Update Posted : December 19, 2014
RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.
PURPOSE: This phase II trial is studying how well vaccine therapy works in treating patients with stage III or stage IV melanoma that cannot be removed by surgery.
|Condition or disease||Intervention/treatment||Phase|
|Intraocular Melanoma Melanoma (Skin)||Biological: incomplete Freund's adjuvant Biological: multi-epitope melanoma peptide vaccine Biological: sargramostim||Phase 2|
- Determine the antitumor immune response in patients with unresectable stage III or IV melanoma treated with vaccine comprising multiple synthetic melanoma peptides, sargramostim (GM-CSF), and Montanide ISA-51.
OUTLINE: Patients receive vaccine comprising multiple synthetic melanoma peptides, sargramostim (GM-CSF), and Montanide ISA-51 on days 1, 8, 15, 29, 36, and 43. Patients undergo removal of the lymph node draining the vaccination site on day 22 to assess immune response.
PROJECTED ACCRUAL: A maximum of 29 patients will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||7 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Vaccination With Synthetic Melanoma Peptides Administered With GM-CSF-in-Adjuvant in Patients With Advanced Melanoma|
|Study Start Date :||August 2002|
|Actual Primary Completion Date :||November 2005|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00089206
|United States, Virginia|
|Cancer Center at the University of Virginia|
|Charlottesville, Virginia, United States, 22908|
|Study Chair:||Craig L. Slingluff, MD||University of Virginia|