Dendritic Cell Vaccination During Lymphoid Reconstruction
NCT ID: NCT00313508
Last Updated: 2014-02-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
18 participants
INTERVENTIONAL
2006-02-28
2012-03-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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A: Peptide-pulsed DC, ALI and Low Dose Fludarabine
Fludarabine: 5 mg/m\^2/day, Auto Lymphocyte Infusion, DC Infusion
Autologous Dendritic Cells (DC)
Given intranodally
Fludarabine
Fludarabine will be administered intravenously (IV) over 30 minutes, daily for 5 consecutive days.
Autologous Lymphocyte Infusion (ALI)
Infusion
B: Peptide-pulsed DC, ALI and High Dose Fludarabine
Fludarabine: 25 mg/m\^2/day, Auto Lymphocyte Infusion, DC Infusion
Autologous Dendritic Cells (DC)
Given intranodally
Fludarabine
Fludarabine will be administered intravenously (IV) over 30 minutes, daily for 5 consecutive days.
Autologous Lymphocyte Infusion (ALI)
Infusion
Interventions
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Autologous Dendritic Cells (DC)
Given intranodally
Fludarabine
Fludarabine will be administered intravenously (IV) over 30 minutes, daily for 5 consecutive days.
Autologous Lymphocyte Infusion (ALI)
Infusion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
16 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
H. Lee Moffitt Cancer Center and Research Institute
OTHER
Responsible Party
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Principal Investigators
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Jeffrey S. Weber, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
H. Lee Moffitt Cancer Center and Research Institute
Locations
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H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States
Countries
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Other Identifiers
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NCI-6241
Identifier Type: OTHER
Identifier Source: secondary_id
MCC-13649
Identifier Type: -
Identifier Source: org_study_id
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