A Phase 1 interventional study of human gp100 plasmid DNA vaccine and mouse gp100 plasmid DNA vaccine in Melanoma (Skin), sponsored by Memorial Sloan Kettering Cancer Center. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2013-03-12.
Sponsored by Memorial Sloan Kettering Cancer Center · Phase 1, Interventional, and Treatment
RATIONALE: Vaccines made from DNA may make the body build an effective immune response to kill tumor cells.
PURPOSE: This randomized phase I trial is studying the side effects and best dose of vaccine therapy in treating patients with stage IIB, stage IIC, stage III, or stage IV melanoma.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a randomized, crossover, dose-escalation study. Patients are randomized to 1 of 2 treatment arms.
In both arms, treatment continues in the absence of disease progression or unacceptable toxicity.
Cohorts of 6-9 patients (at least 3 per treatment arm) receive escalating doses of human and mouse gp100 DNA vaccines until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 9 patients experience dose-limiting toxicity.
After completion of study treatment, patients are followed at 3 weeks and then annually for 15 years.
PROJECTED ACCRUAL: Approximately 18-27 patients will be accrued for this study within 6-9 months.
3,005 studies on the registry are indexed under Melanoma; 519 are open to participants now.
This study's enrollment of 19 is below the median of 38 across 2,350 interventional studies indexed under Melanoma.
Browse Melanoma studies →Memorial Sloan Kettering Cancer Center is the lead sponsor of 1,930 studies on the registry; 328 are open to participants now.
Of its 128 completed or terminated interventional studies of FDA-regulated products, 66 (52%) have results posted.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
Histologically confirmed malignant melanoma
Stage IIB, IIC, III, or IV disease
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Immunologic
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Patients receive human gp100 DNA vaccine intramuscularly (IM) once in weeks 1, 4, and 7. Patients then receive mouse gp100 DNA vaccine IM once in weeks 10, 13, and 16.
Biological: human gp100 plasmid DNA vaccine · Biological: mouse gp100 plasmid DNA vaccine
Patients receive mouse gp100 DNA vaccine IM once in weeks 1, 4, and 7. Patients then receive human gp100 DNA vaccine IM once in weeks 10, 13, and 16
Biological: human gp100 plasmid DNA vaccine · Biological: mouse gp100 plasmid DNA vaccine
safety and feasibility
Time frame: 2 years
maximum tolerated dose
Time frame: 2 years
antibody and T-cell response
Time frame: 2 years
This study is completed, as verified in Mar 2013. You cannot join it, but the record below documents what was studied.
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Memorial Sloan Kettering Cancer Center