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Sponsors and Collaborators: |
Memorial Sloan-Kettering Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00398073 |
RATIONALE: Vaccines made from DNA may help the body build an effective immune response to kill tumor cells.
Giving the vaccine in different ways may make a stronger immune response and kill more tumor cells.
PURPOSE: This randomized clinical trial is studying two different ways of giving vaccine therapy to compare how well they work in treating patients with stage IIB, stage IIC, stage III, or stage IV melanoma.
Condition | Intervention |
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Intraocular Melanoma Melanoma (Skin) |
Biological: mouse gp100 plasmid DNA vaccine Procedure: adjuvant therapy |
Study Type: | Interventional |
Study Design: | Treatment, Randomized |
Official Title: | Injection of AJCC Stage IIB, IIC, III and IV Melanoma Patients With Mouse gp100 DNA: A Pilot Study to Compare Intramuscular Jet Injection With Particle Mediated Delivery |
Estimated Enrollment: | 30 |
Study Start Date: | October 2006 |
Estimated Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a randomized, pilot study. Patients are randomized to 1 of 2 treatment arms.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
Ages Eligible for Study: | 1 Year and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed malignant melanoma
Stage IIB, IIC, III, or IV disease
Patients free of disease after surgical resection must meet 1 of the following criteria:
Choroidal (uveal) melanoma allowed provided 1 of the following criteria is met:
PATIENT CHARACTERISTICS:
No evidence of any condition at the proposed site(s) of vaccine administration that might interfere with the interpretation of local skin reactions, including any of the following:
No history or evidence (within the past 5 years) of a physician-diagnosed chronic or recurrent inflammatory skin disease at the proposed site of vaccine administration, including any of the following:
PRIOR CONCURRENT THERAPY:
United States, New York | |
Memorial Sloan-Kettering Cancer Center | |
New York, New York, United States, 10021 |
Principal Investigator: | Jedd D. Wolchok, MD | Memorial Sloan-Kettering Cancer Center |
Study ID Numbers: | CDR0000513257, MSKCC-06113 |
Study First Received: | November 9, 2006 |
Last Updated: | April 3, 2009 |
ClinicalTrials.gov Identifier: | NCT00398073 History of Changes |
Health Authority: | United States: Federal Government |
stage II melanoma stage III melanoma stage IV melanoma recurrent melanoma |
ciliary body and choroid melanoma, medium/large size ciliary body and choroid melanoma, small size recurrent intraocular melanoma metastatic intraocular melanoma |
Eye Neoplasms Uveal Melanoma Eye Diseases Adjuvants, Immunologic Melanoma of the Choroid Recurrence Melanoma |
Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Nevus, Pigmented Intraocular Melanoma Neuroepithelioma Nevus |
Neuroectodermal Tumors Neoplasms Neoplasms by Site Neoplasms by Histologic Type Eye Neoplasms Eye Diseases |
Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Nevi and Melanomas Neuroendocrine Tumors Melanoma |