Dendritic Cell Vaccination During Lymphoid Reconstruction

Completed · Phase 1

Conditions studied: Intraocular Melanoma, Melanoma (Skin)

In brief

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.

Key facts

Study ID: NCT00313508
Run by: H. Lee Moffitt Cancer Center and Research Institute
People needed: 18
Starts: 2006-02-01
Expected to finish: 2012-03-01
Last updated by the study team: 2014-02-21

Who can join

Age: 16 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

H. Lee Moffitt Cancer Center and Research Institute — Tampa, Florida, United States

Full record on ClinicalTrials.gov

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