Clinical Trials: Vaccine/Immunotherapy

The CVC is conducting the following clinical trials involving vaccines. Additional information about individual trials may be obtained by contacting christine_canning@dfci.harvard.edu.

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GVAX (Adenoviral) Clinical Trials

Title: DF/HCC 03-218/ A Phase IB Study of Vaccination with Autologous, Lethally Irradiated Melanoma Cells Engineered by Adenoviral Mediated Gene Transfer to Secrete Human Granulocyte-Macrophage Stimulating Factor
PI:  F. Stephen Hodi, MD
Institution/s:  DFCI/BWH/MGH
Status: Open to accrual

Title: DF/HCC 04-023/ GM-CSF Secreting Leukemia Cell Vaccinations after Allogeneic Non-Myeloablative Peripheral Blood Stem Cell Transplantation in Patients with Advanced Myelodysplastic Syndrome or Refractory Acute or Advanced Chronic Myeloid Leukemia
PI:  Vincent Ho, MD
Institution/s:  DFCI
Status: Accrual is complete

Title: DF/HCC 05-111/ A Phase I Trial of Vaccination with Autologous, Lethally Irradiated Breast Cancer Cells Engineered by Adenoviral Mediated Gene Transfer to Secrete Human Granulocyte-Macrophage Stimulating Factor in Metastatic Breast Cancer Patients
PI:  Karen S. Anderson, MD
Institution/s:  DFCI/BWH
Status: Closed to accrual

Title: DF/HCC 05-115/ A Phase I Trial of Vaccination with Autologous, Lethally Irradiated Tumor Cells Engineered by Adenoviral Mediated Gene Transfer to Secrete Human Granulocyte-Macrophage Stimulating Factor in Pediatric and Adult Patients: GVAX for Advanced Clear Cell Sarcoma, Translocation Associated Renal Cell Carcinoma, Alveolar Soft Part Sarcoma and for Children with Stage IV Melanoma
PI:  F. Stephen Hodi, MD
Institution/s:  DFCI/BWH/CHMC
Status: Accrual is complete

Title: DF/HCC 07-058/ A Phase Ib Trial of Vaccination with Lethally Irradiated Non-Small Cell Lung Cancer Cells Engineered by Adenoviral Mediated Gene Transfer to Secrete Granulocyte- Macrophage Colony Stimulating Factor in Stage IIIB and IV patients with malignant Pleural Effusions
PI:  Christopher Latham, MD
Institution/s:  DFCI/MGH
Status: Pending

Title: DF/HCC 08-216/ A Phase IB Study of Autologous Vaccination with Lethally Irradiated Autologous Breast Cancer Cells Engineered by Adenoviral Mediated Gene Transfer to Secrete GM-CSF Following Preoperative Chemotherapy in Women with Operable Breast Cancer
PI:  Karen S. Anderson, M.D.
Institution/s:  DFCI/BWH
Status: Pending

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GVAX (GM-K562) Clinical Trials

Title: DF/HCC 06-196/ Reduced Intensity Stem Cell Transplantation for Advanced Chronic Lymphocytic Leukemia Followed by Vaccination with Lethally Irradiated Autologous Tumor Cells Admixed with Granulocyte- Macrophage Colony Stimulating Factor Secreting K562 Cells
PI:  Catherine Wu, MD
Institution/s:  DFCI
Status: Open to accrual

Title: DF/HCC 06-275/ A Phase I Trial of Vaccination with Lethally Irradiated Lymphoma Cells Admixed with Granulocyte- Macrophage Colony Stimulating Factor Secreting K562 Cells for the Treatment of De Novo or Relapsed/Refractory Follicular Lymphoma
PI:  Eric Jacobsen, MD
Institution/s:  DFCI
Status: open to accrual

Title: DF/HCC 06-349/ A Phase I Trial of Vaccination with Lethally Irradiated Glioma Cells Admixed with Granulocyte- Macrophage Colony Stimulating Factor Secreting K562 Cells in Patients Undergoing Craniotomy for Recurrent Tumor
PI: William Curry, MD
Institution/s:  DFCI/BWH/MGH
Status: Open to accrual

Title: DF/HCC 08-160/ Vaccination with lethally irradiated autologous myeloblasts admixed with granulocyte macrophage-colony stimulating factor secreting K562 cells (GM-K562) in patients with myeloid malignancies after allogeneic hematopoietic stem cell transplantation
PI: Vincent Ho, MD
Institution: DFCI
Status: Open to accrual

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Post GVAX Immunotherapy Clinical Trials

Title: DF/HCC 01-228/ Anti-Cytotoxic T-Lymphocyte Associated Antigen-4 (Anti CTLA-4) Humanized Monoclonal Antibody (MDX CTLA-4 NSC # 732442 Previously 720801) in Patients Previously Vaccinated with GM-CSF Based Autologous Tumor Vaccines (CTEP Protocol P-5708) and Patients with Acute Myelogenous Leukemia, Myelodysplasia, and Non-Small Cell Lung Cancer who Have Not Received a Prior Vaccine (CTEP P-5708)
PI:  F. Stephen Hodi, MD
Institution/s:  DFCI/MGH
Status: Closed

Title: DF/HCC 04-042/ A Phase I Trial of Granulocyte-Macrophage Colony Stimulating Factor and Gamma Interferon in Previously Vaccinated Patients
PI:  F. Stephen Hodi, MD
Institution/s:  DFCI/MGH
Status: Open to accrual

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Cellular Immunotherapy Clinical Trials

Title: DF/HCC 06-179/ A Pilot Feasibility Study of Epstein-Barr Virus Specific Therapy for Nasopharyngeal Carcinoma
PI: Lori Wirth, MD
Institution/s:  DFCI/BWH
Status: Closed to accrual

Title: DF/HCC 06-432/ A Phase I Trial of in vitro Expanded Autologous Invariant Natural Killer Cells in Cancer
PI: Steven Balk, MD
Institution/s:  DFCI/BIDMC
Status: Open to accrual

Title: DF/HCC 06-250/ Adoptive Transfer of MART 1/Melan A CTL
PI: Marcus Butler, MD
Institution/s:  DFCI
Status: Open to accrual

Title: DF/HCC 08-292/ A Phase II Study of Epstein-Barr Virus-Specific Immunotherapy for Nasopharyngeal Carcinoma
PI: Marshall Posner, M.D.
Institution/s: DFCI/BWH
Status: Open to accrual

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Information for Patients

The CVC is developing new, disease-specific cancer vaccines by working closely with individual programs at DFCI.

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