Status:
COMPLETED
Dendritic Cell Vaccination During Lymphoid Reconstruction
Lead Sponsor:
H. Lee Moffitt Cancer Center and Research Institute
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Intraocular Melanoma
Melanoma (Skin)
Eligibility:
All Genders
16+ years
Phase:
PHASE1
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 c...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2012
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00313508
Start Date
February 1 2006
End Date
March 1 2012
Last Update
February 21 2014
Active Locations (1)
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1
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612-9497