Dendritic Cell Vaccination During Lymphoid Reconstruction
A Dose Ranging Trial of MART-1/gp100/Tyrosinase/NY-ESO-1 Peptide-Pulsed Dendritic Cells Matured Using Cytokines With Autologous Lymphocyte Infusion With or Without Escalating Doses of Fludarabine for Patients With Chemotherapy-naive Metastatic Melanoma
2 other identifiers
interventional
18
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Feb 2006
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2006
CompletedFirst Submitted
Initial submission to the registry
April 11, 2006
CompletedFirst Posted
Study publicly available on registry
April 12, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2012
CompletedFebruary 21, 2014
December 1, 2012
6.1 years
April 11, 2006
February 20, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
3 years, 6 months
Secondary Outcomes (2)
Progression-Free Survival (PFS)
3 years, 6 months
Time to Progression (TTP)
3 years, 6 months
Study Arms (2)
A: Peptide-pulsed DC, ALI and Low Dose Fludarabine
EXPERIMENTALFludarabine: 5 mg/m\^2/day, Auto Lymphocyte Infusion, DC Infusion
B: Peptide-pulsed DC, ALI and High Dose Fludarabine
EXPERIMENTALFludarabine: 25 mg/m\^2/day, Auto Lymphocyte Infusion, DC Infusion
Interventions
Given intranodally
Fludarabine will be administered intravenously (IV) over 30 minutes, daily for 5 consecutive days.
Infusion
Eligibility Criteria
You may qualify if:
- Metastatic melanoma with measurable disease after attempted curative surgical therapy and without prior chemotherapy; adjuvant interferon or isolated limb perfusion is allowed.
- Tumor tissue must be available for immunohistochemical analysis, and specimens will stained for MART-1/tyrosinase/NY-ESO-1 by immunohistochemical staining and will also be stained for HMB-45 by immunohistochemistry, and positivity for at least one will be an entry requirement.
- Patients must be HLA-A \*0201 positive by a DNA polymerase chain reaction (PCR) analysis.
- Serum creatinine of 2.0 mg/dl or less, total bilirubin of 2.0 mg/dl or less, and alanine transaminase/aspartic transaminase (ALT/AST) of less than 3X institutional upper limit of normal (ULN).
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Patients must be able to understand and sign an Institutional Review Board (IRB) approved informed consent form.
- Patients must have whit blood count (WBC) of 3000 or greater, platelets of 100,000 or greater, and hemoglobin of 9.0 gm/dl or more.
- Patients must be seropositive for Epstein-Barr virus (EBV).
- Patients with unresectable stages III/IV uveal melanoma and metastatic mucosal melanoma will be eligible for this trial.
You may not qualify if:
- Patients who are undergoing or have undergone in the past month any other therapy for their melanoma, including radiation therapy, chemotherapy and adjuvant therapy.
- Have major systemic infections, coagulation disorders, or other major medical illnesses (MI) of the cardiovascular or respiratory systems, or have had a documented MI in the last 6 months.
- Require steroid therapy.
- Are pregnant or lactating.
- Are known to be positive for hepatitis BsAg, Hepatitis C or human immunodeficiency virus (HIV) antibody, since cells for DC cannot be grown in the laboratory when virus contaminated.
- Have a prior history of uveitis or autoimmune inflammatory eye disease.
- Have previously received the gp100 209-217 (210M), MART-1 26-35 (27L), gp100 280-288 (288V), tyrosinase 207-215 or NY-ESO-1 157-165 (165V) peptides.
- 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.
- Since this trial increase the risk of immunological impairment, patients with the following will be excluded from this trial: Hypogammaglobulinemia, Lymphocytopenia, History of impaired immune response, tuberculosis (TB) or positive purified protein derivative (PPD) unless they have received BCG vaccine.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612-9497, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jeffrey S. Weber, M.D., Ph.D.
H. Lee Moffitt Cancer Center and Research Institute
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 11, 2006
First Posted
April 12, 2006
Study Start
February 1, 2006
Primary Completion
March 1, 2012
Study Completion
March 1, 2012
Last Updated
February 21, 2014
Record last verified: 2012-12