A Phase 1/2 interventional study of dendritic cell-MART-1 peptide vaccine in Melanoma (Skin), sponsored by Jonsson Comprehensive Cancer Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-08-03.
Sponsored by Jonsson Comprehensive Cancer Center · Phase 1/2, Interventional, and Treatment
RATIONALE: Vaccines made by inserting a laboratory-treated gene into a person's white blood cells may make the body build an immune response to kill tumor cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of vaccine therapy and to see how well it works in treating patients with stage IV or recurrent malignant melanoma.
3,006 studies on the registry are indexed under Melanoma; 520 are open to participants now.
This study's enrollment of 28 is below the median of 38 across 2,351 interventional studies indexed under Melanoma.
Browse Melanoma studies →Jonsson Comprehensive Cancer Center is the lead sponsor of 396 studies on the registry; 67 are open to participants now.
Of its 37 completed or terminated interventional studies of FDA-regulated products, 2 (5%) have results posted.
Counted across the registry records on this site, refreshed daily.
Adequate baseline hematological function as assessed by the following laboratory values within 30 days prior to study entry:
Exclusion Criteria
Patients who meet any one of the following criteria will be excluded from study entry:
All allowed medications or treatments should be kept to a minimum and recorded. All questions regarding concomitant medications should be referred to the study chair or investigator.
Medications and Treatments Not Allowed
A\*0201 positive subjects will receive MART-1 adenovirus-transduced dendritic cells (DC)at dose of 10\^6. Subjects will receive a total of three biweekly vaccinations given intradermally. If significant clinical or immunological response (to be defined later) is noted, subjects will be eligible for up to 6 additional monthly vaccine administrations.
Biological: dendritic cell-MART-1 peptide vaccine
A\*0201 positive subjects will receive MART-1 adenovirus-transduced dendritic cells (DC)at dose of 10\^7. Subjects will receive a total of three biweekly vaccinations given intradermally. If significant clinical or immunological response (to be defined later) is noted, subjects will be eligible for up to 6 additional monthly vaccine administrations.
Biological: dendritic cell-MART-1 peptide vaccine
Subjects will receive MART-1 adenovirus-transduced dendritic cells (DC)at dose of 10\^7. Subjects will receive a total of three biweekly vaccinations given intradermally. If significant clinical or immunological response (to be defined later) is noted, subjects will be eligible for up to 6 additional monthly vaccine administrations.
Biological: dendritic cell-MART-1 peptide vaccine
Subjects will receive MART-1 adenovirus-transduced dendritic cells (DC)at dose of 10\^7. Subjects will receive a total of three biweekly vaccinations given intradermally. If significant clinical or immunological response (to be defined later) is noted, subjects will be eligible for up to 6 additional monthly vaccine administrations.
Biological: dendritic cell-MART-1 peptide vaccine
Subjects will receive MART-1 adenovirus-transduced dendritic cells (DC)at dose of 10\^7. Subjects will receive a total of three biweekly vaccinations given intradermally. If significant clinical or immunological response (to be defined later) is noted, subjects will be eligible for up to 6 additional monthly vaccine administrations.
Biological: dendritic cell-MART-1 peptide vaccine
Subjects will receive MART-1 adenovirus-transduced dendritic cells (DC)at dose of 10\^6 (for arm A) or 10\^7 (for arms B-E). Subjects will receive a total of three biweekly vaccinations given intradermally. If significant clinical or immunological response (to be defined later) is noted, subjects will be eligible for up to 6 additional monthly vaccine administrations.
Optimal dose
Time frame: 7 months
Safety of administering MART-1 adenovirus transduced dendritic cells
Time frame: 7 months
Immunological response (peptide-specific T cell generation, skin test immunohistology)
Time frame: 7 months
Clinical response (disease improvement or disease progression)
Time frame: 7 months
This study is completed, as verified in Jul 2012. You cannot join it, but the record below documents what was studied.
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Jonsson Comprehensive Cancer Center