A Phase 1 interventional study of Autologous Dendritic Cells (DC) and Fludarabine in Intraocular Melanoma and Melanoma (Skin), sponsored by H. Lee Moffitt Cancer Center and Research Institute. Completed at 1 site in United States. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2014-02-21.
Sponsored by H. Lee Moffitt Cancer Center and Research Institute · Phase 1, Interventional, and Treatment
This is a randomized, controlled, multicenter, dose-escalation study of fludarabine. Patients are randomized to 1 of 2 treatment arms.
The purpose of this study is to find out what side effects are caused in this study and whether Fludarabine with the dendritic cell vaccine (DC vaccine) can increase the ability of the immune system to recognize melanoma.
This is a dose ranging study of intranodal administration of autologous dendritic cells (DC) pulsed with tumor antigen class I peptides derived from MART-1 (26-35) (27L), gp100 (209-217 (210M), gp100 280-288 (288V), NY-ESO-1 157-165 (165V) and tyrosinase 207-215 as well as class II MART-1 (51-73), NY-ESO-1 (119-143), MAGE-3 (243-258) and tyrosinase (450-462) peptides preceded by Autologous Lymphocyte Infusion (ALI) and one of two doses of Fludarabine. The nine or ten amino acid peptides representing HLA-A2 restricted T cell epitopes of MART-1, gp100, NY-ESO-1 and tyrosinase will be pulsed onto autologous dendritic cells produced by incubation of peripheral blood mononuclear cells obtained by apheresis with interleukin-4 (IL-4) and GM-CSF and pulsed with four helper peptides then matured with a cytokine cocktail including TNF-a, IL-6, IL-1b and PGE2. Melanoma antigen peptide-pulsed dendritic cells will be administered at a total dose of 10 million cells each for four intranodal injections to patients with chemotherapy-naïve metastatic melanoma.
DC matured with a cytokine cocktail and pulsed with class I and II peptides will be injected intranodally, weekly for two doses, then every two weeks for two doses, for a total of four injections to each cohort.
3,006 studies on the registry are indexed under Melanoma; 520 are open to participants now.
This study's enrollment of 18 is below the median of 38 across 2,351 interventional studies indexed under Melanoma.
Browse Melanoma studies →H. Lee Moffitt Cancer Center and Research Institute is the lead sponsor of 533 studies on the registry; 74 are open to participants now.
Of its 99 completed or terminated interventional studies of FDA-regulated products, 57 (58%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Have had another malignancy other than cervical carcinoma-in-situ or basal cell
/squamous cancer of the skin, unless they have undergone curative therapy more than 5 years ago and are still free of detectable disease.
Fludarabine: 5 mg/m\^2/day, Auto Lymphocyte Infusion, DC Infusion
Biological: Autologous Dendritic Cells (DC) · Drug: Fludarabine · Biological: Autologous Lymphocyte Infusion (ALI)
Fludarabine: 25 mg/m\^2/day, Auto Lymphocyte Infusion, DC Infusion
Biological: Autologous Dendritic Cells (DC) · Drug: Fludarabine · Biological: Autologous Lymphocyte Infusion (ALI)
Given intranodally
Also known as: Autologous Dendritic Cells (DC) pulsed with tumor antigen class I peptides derived from MART-1 (26-35) (27L), gp100, (209-217 (210M), gp100 280-288 (288V), NY-ESO-1 157-165 (165V) and tyrosinase 207-215, as well as class II MART-1 (51-73), NY-ESO-1 (119-143), MAGE-3 (243-258) and tyrosinase, (450-462) peptides preceded by Autologous Lymphocyte Infusion (ALI) and one of two doses of, Fludarabine.
Fludarabine will be administered intravenously (IV) over 30 minutes, daily for 5 consecutive days.
Also known as: fludarabine phosphate, FLUDARA
Infusion
Also known as: ALI
Overall Survival (OS)
Overall Survival is defined as the time from first day of treatment to time of death due to any cause. If a patient is still alive, survival time is censored at the time of last follow-up.
Time frame: 3 years, 6 months
Progression-Free Survival (PFS)
Progression-Free Survival is defined as the time from first day of treatment to the first observation of disease progression or death due to any cause. If a patient has not progressed or died, progression-free survival is censored at the time of last follow-up. Evaluation of target lesions: Progressive Disease (PD)- At least a 20% increase in the sum of longest diameter (LD) of target lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
Time frame: 3 years, 6 months
Time to Progression (TTP)
Time to Progression is defined as the time from first day of treatment to the first observation of disease progression or death due to disease. If failure has not occurred, failure time is censored at the time of last follow-up. Evaluation of target lesions: Progressive Disease (PD)- At least a 20% increase in the sum of longest diameter (LD) of target lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
Time frame: 3 years, 6 months
This study is completed, as verified in Dec 2012. You cannot join it, but the record below documents what was studied.
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H. Lee Moffitt Cancer Center and Research Institute