Universal Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF)-Producing and CD40L Expressing Bystander Cell Line for Tumor Vaccine in Melanoma
Melanoma (Skin)
About this trial
This is an interventional treatment trial for Melanoma (Skin) focused on measuring recurrent melanoma, stage III melanoma, stage IV melanoma
Eligibility Criteria
Inclusion Criteria: Histologically confirmed stage IIIC or stage IV melanoma Measurable disease Age 18 or older Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 No radiation therapy within 2 weeks prior to first vaccine administration No chemotherapy within 4 weeks prior to first vaccine administration No steroid therapy within 4 weeks prior to first vaccine administration No surgery within 10 days prior to first vaccine administration Patient's written informed consent Patient's ability to comply with the visit schedule and assessments required by the protocol Adequate organ function (measured within a week of beginning treatment): White blood count (WBC) > 3,000/mm^3 and absolute neutrophil count (ANC) >1500/mm^3 Platelets > 100,000/mm^3 Hematocrit > 25% and Hgb > 8 g/dL Bilirubin < 2.0 mg/dL Creatinine < 2.0 mg/dL, or creatinine clearance > 60 mL/min Exclusion Criteria: Symptomatic or untreated brain metastasis Any serious ongoing infection Current corticosteroid or other immunosuppressive therapy Any other pre-existing immunodeficiency condition (including known HIV infection) Pregnant or lactating women -- Patients in reproductive age must agree to use contraceptive methods for the duration of the study (*A pregnancy test will be obtained before treatment) ECOG performance status of 2, 3, or 4 Any second active primary cancer
Sites / Locations
- H. Lee Moffitt Cancer Center and Research Institute
Arms of the Study
Arm 1
Experimental
Vaccine Therapy
Treatment consisted of intradermal vaccine injections at 28-day intervals for a total of 3 immunizations. Injections were performed on Days 1, 29, and 57.