NYUCI Clinical Trials Supported
To date, the laboratory has supported seven immunotherapy trials for cancer at NYU and two HIV vaccine trials at Massachusetts General Hospital:
- NYU 02-010. Nina Bhardwaj, principal investigator. Anna Pavlick, DO and Sylvia Adams, MD, co-investigators. Autologous dendritic cells vs. Montanide ISA-51 adjuvant as vehicles for a 6-peptide / KLH vaccine in HLA-A2+ patients with resected stage IIb-III melanoma.
- ACTG-5130 (MGH). Nina Bhardwaj, vice-chair. NIAID, sponsor. A phase I/II study to evaluate the safety and immunogenicity of the subcutaneous administration of ALVAC-HIV vcp1452 infected autologous dendritic cells vs. the subcutaneous administration of ALVAC-HIV vcp1452 to HIV-infected subjects. Jeffrey M. Jacobson, protocol chair.
- BB-IND 9446 (MGH). Nina Bhardwaj, principal investigator. Rajesh T. Gandhi, MD and Bruce D. Walker, MD, co-investigators. Immune Responses to antigen-bearing dendritic cells in HIV-1-infected Individuals.
- NYU 04-053. Nina Bhardwaj, principal investigator. Sylvia Adams and Anna Pavlick, co-investigators. Ludwig Institute for Cancer Research, sponsor. Topical Imiquimod cream as adjuvant for NY-ESO-1 protein vaccine in patients with resected stage IIb-III melanoma.
- NYU 05-120. Nina Bhardwaj, principal investigator. Sylvia Adams and Anna Pavlick, co-investigators. Ludwig Institute for Cancer Research, sponsor. Unmethylated CpG DNA plus Montanide ISA-51 as adjuvants for NY-ESO-1 protein vaccine in patients with a variety of cancers.
- NYU 06-179. Anna Ferrari, MD, principal investigator. Sponsored By ECOG (ECOG-E9802). A phase II study of PROSTVAC-V (Vaccinia)/TRICOM and PROSTVAC-F (Fowlpox)/TRICOM with GM-CSF in patients with PSA progression after local therapy for prostate cancer.
- NYU 07-062. Michael Gruber, MD, principal investigator. Northwest Biotherapeutics, sponsor. A Phase II Clinical Trial Evaluating DCVax® - Brain, Autologous Dendritic Cells Pulsed with Tumor Lysate Antigen for the Treatment of Glioblastoma Multiforme.
- NYU 07-251. Anna Ferrari, principal investigator. Cell Genesys, sponsor. A Phase 3 Randomized, Open-Label Study of Docetaxel in Combination with GVAX CG1940 and CG8711 versus Docetaxel and Prednisone in Taxane-Naïve Patients with Metastatic Hormone-Refractory Prostate Cancer With Pain.
- NYU 07-306. Sylvia Adams and Harvey Pass, MD., co-principal investigators. GlaxoSmithKline, sponsor. A double-blind, randomized, placebo-controlled Phase III study to assess the efficacy of recMAGE-A3 + AS15 Antigen Specific Cancer Immunotherapeutic as adjuvant therapy in patients with resectable MAGE-A3-positive Non-Small Cell Lung cancer.
The laboratory is scheduled to support at least three additional immunotherapy trials in 2008.

