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Cancer Immunology

Clinical Trials

Clinical Trials

An important component of the Program in Cancer Immunology is its strong interface and involvement with multiple Disease Programs to promote clinical immunotherapy trials across the Dana-Farber/Harvard Cancer Center affiliated institutions in the areas of bone marrow transplantation, adoptive cellular therapies and cancer vaccines.  As illustrated below, there are clinical collaborations in Leukemia, Lymphoma, Gynecologic Oncology, Cutaneous Oncology, Thoracic Oncology, Breast Cancer, Prostate Cancer, Renal Cancer, Neuro-oncology, and Biostatistics.  Most of these clinical studies represent the scientific input of Cancer Immunology Program Members, either through investigator-initiated trials or contributions to the scientific foundation and analysis of the trials.  These studies (with DF/HCC protocol numbers) currently include: 

Breast Cancer

02-310.  A Phase I Trial of an Admixture of Recombinant Vaccinia Viruses that Express DF3/MUC1 and Tricom (B7.1, ICAM-1, and LFA-3) in Patients with Metastatic Adenocarcinoma of the Breast.

03-221.  Vaccination of Patients with Breast Cancer with Dendritic Cell/Tumor Fusions and IL-12.

GI Malignancies

02-324.  Phase Ia/Ib Trial of 2nd Generation Designer T Cells in Adenocarcinoma.

Gynecological Cancer

99-098.  A Phase I Study of Vaccination with Lethally Irradiated, Autologous Acute Ovarian Carcinoma Cells Engineered by Adenoviral Mediated Gene Transfer to Secrete Granulocyte-Macrophage Colony Stimulating Factor.

01-228.  Anti-Cytotoxic T-Lymphocyte-Associated Antigen-4 (anti-CTLA-4) Humanized Monoclonal Antibody (MDX-CTLA-4) in Patients Previously Vaccinated with GM-CSF-Based Autologous Tumor Vaccines.

03-004.  Allogeneic Stem Cell Transplantation with Non-Myeloablative Conditioning Followed by Intraperitoneal Donor Leukocyte Infusions for Subjects with Advanced Ovarian Cancer. 


99-205.  A Phase I Open-Label Safety Study of Haploidentical Bone Marrow Transplantation (BMT) after Ex Vivo Treatment of Bone Marrow with Anti-B7.1 and Anti-B7.2 Antibodies.

99-249.  A Phase I Study of Vaccination with Lethally Irradiated Autologous Myeloblasts Engineered by Adenoviral Mediated Gene Transfer to Secrete GM-CSF in Patients with Advanced Myelodysplasia or Acute Myelogenous Leukemia.

00-051.  Filgrastim-Mobilized Peripheral Blood Stem Cells for Primary Allogeneic Transplantation with Unrelated Donors. 

 00-142.  Open-Label, Multicenter, Phase II Study of Autologous ISF 154 Expressing Transduced CLL Cells in B Cell Chronic Lymphocytic Leukemia Patients Enrolled in Two Parallel Arms. 

00-153.  A Phase III Study of STI571 versus Interferon-a (IFN-a) combined with Cytarabine (ARA-C) in patients with newly diagnosed untreated Philadelphia chromosome positive (PH+) chronic myelogenous leukemia in chronic phase (CML-CP). 

00-293.  Upregulation Of Cell Adhesion Molecules And Chemokines In Skin Microvasculature As A Predictor Of Acute Graft-Versus-Host Disease Following Bone Marrow Transplantation Or Donor Leukocyte Infusions.

01-290.  Vaccination in Peripheral Stem Cell Transplant Setting for Acute Myelogenous Leukemia: The use of Autologous Tumor Cells with an Allogeneic GM-CSF Producing Bystander Cell Line (K-0009). 

02-003.  Infusion of Donor Dendritic Cells and Donor Lymphocytes in Patients with Relapsed Hematologic Malignancies after Allogeneic Transplant. 

02-052.  A Phase II Multicenter Clinical Trial Evaluating the Use of Humanized Monoclonal Anti-CD3 Antibody Visilizumab (Nuvion) as Second-Line Therapy for Glucocorticoid-Refractory, Acute Graft-Versus-Host-Disease. 

02-057.  Tacrolimus, Sirolimus and Methotrexate as Graft versus Host Disease Prophylaxis after Allogeneic Non-myeloablative Peripheral Blood Stem Cell Transplantation.

02-090.  Open Label Phase II Trial of Sirolimus in Combination With Tacrolimus For Graft-vs-Host Disease Prophylaxis After Matched, Related Allogeneic Hematophoietic Stem Cell Transplantation.

02-236.  A CRC Investigator-Initiated Study of Combined Rituximab And High Dose Methylprednisolone for the Treatment Of Chronic Lymphocytic Leukemia (CLL) or Prolymphocytic Leukemia (PLL). 

04-023.  GM-CSF Secreting Leukemia Cell Vaccinations after Allogeneic Non-myeloablative Peripheral Blood Stem Cell Transplantation in Patients with Myelodysplasia Syndrome or Refractory Acute or Advanced Chronic Myeloid Leukemia.

04-067.  A CRC Phase II Study of Subcutaneous Campath-1H in Patients with B-Cell Chronic Lymphocytic Leukemia and Residual Disease After Chemotherapy. 


00-192.  A Multicenter, Open Label Trial to Evaluate The Efficacy And Safety of Y-ibritumomab tiuxetan (IDEC-Y2B8, Zevalin) Radioimmunotherapy of Relapsed or Refractory Low-Grade or Follicular Transformed B-Cell Non-Hodgkin's Lymphoma. 

00-276.  Randomized Phase III Study in Low Grade Lymphoma Comparing Maintenance Anti-Cd20 Antibody Versus Observation Following Induction Therapy. 

02-077.  A Study Evaluating Safety and Efficacy of the CliniMACS System For Use In Autologous PBPC Transplantation for B Cell Non-Hodgkins Lymphoma and Chronic Lymphocytic Leukemia Patients Receiving High-Dose Chemotherapy.

02-165.  An Open-Label Multi-Center, Phase I/II Study of the Safety and Biological Activity of AlloMune Component II: MEDI-507 as Part of a Non-Myeloablative Conditioning Regimen for Allogeneic Stem Cell Transplantation in the Treatment of Subjects with Refractory Non-Hodgkin's Lymphoma or Hodgkin's Disease. 

02-170.  Active Immunization of Sibling Stem Cell Transplant Donors against Purified Myeloma Protein of the Stem Cell Recipient with Multiple Myeloma in the Setting of Non-Myeloblative, HLA-Matched Allogeneic Peripheral Blood Stem Cell Transplantation. 

02-229.  Randomized Phase II Trial Of EPOCH Given Either Concurrently Or Sequentially With Rituximab In Patients With Intermediate Or High Grade HIV-Associated B-Cell Non-Hodgkin's Lymphoma.

02-263.  Open Label Study of ONTAK (denileukin difitox, DAB IL-2) to Estimate Response In Cutaneous T-Cell Lymphoma (CTCL) according to CD25 Status.

03-036.  Phase I Study of Zevalin in Waldenstrom's Macroglobulinemia and CD20+ Multiple Myeloma.

030-037.  The Use of Dendritic Cell/Tumor Fusions as a Novel Tumor Vaccine in Patients with Multiple Myeloma. 

03-107.  A Phase I/II Trial of IDEC-114 (Anti-CD80 Monoclonal Antibody) in Combination with Rituxan for Patients with Relapsed or Refractory Follicular Lymphoma. 

03-134.  An Open-Label, Randomized Study to Access Two Different Strategies of Combining Dexamethasone with VELCADE in Patients with Relapsed Multiple Myeloma who have Failed Four or More Lines of Therapy.

03-161.  IDEC 106-10 -- A Prospectively Randomized, Phase III, Multicenter, Controlled Trial to Evaluate the Safety and Efficacy of the Zevalin Therapeutic Regimen Plus Rituxan Compared with Rituxan Alone in Patients with Relapsed or Refractory Follicular Non-Hodgkin's Lymphoma.

03-240.  The Use of Dendritic Cell/Tumor Fusions as a Novel Tumor Vaccine in Patients with Multiple Myeloma.

03-248.  Phase II Study of Velcade in Waldenstrom's Macroglobulinemia.

03-294.  A Phase II Study of Fludarabine and Rituximab for the Treatment of Marginal Zone Non-Hodgkin's Lymphoma. 

03-328.  Phase II Trial of VELCADE (bortezomib) in Patients with Previously Untreated Multiple Myeloma.

03-376.  A Phase II Multi-Dose Study of SGN-30 (anti-CD30 mAb) in Patients with Refractory or Recurrent Hodgkin's Disease or Anaplastic Large Cell Lymphoma.

03-413.  A Trial of Tandem Autologous Stem Cell Transplants +/- Post Second Autologous Transplant Therapy versus Single Autologous Stem Cell Transplant Followed by Matched Sibling Non-Myeloablative Allogenic Stem Cell Transplant for Patients with Mulitple Myeloma.

03-415.  A Phase 2 Study to Evaluate Safety and Efficacy of Specific Immunotherapy, Recombinant Idiotype Conjugated to KLH (GTOP-99) and GM-CSF Following the Anti-CD20 Antibody, Rituxan, in Previously Treated Patients with Follicular Non- Hodgkin's Lymphoma. 

04-012.  A Phase II Study of Xcellerated T Cells in Patients with Relapsed or Refractory Indolent Non-Hodgkin's Lymphoma. 

04-167.  A Phase II Multi-Center Study of Gallium Nitrate and Rituximab in Subjects with Relapsed or Refractory Diffuse Large Cell Non-Hodgkin's Lymphoma. 

04-180.  Protocol FavId-06, Phase III, Randomized, Double-Blind Placebo-controlled Trial of FavId and CM-CSF versus Placebo and GM-CSF Following Rituximab in Subjects with Follicular B-Cell Non-Hodgkin's Lymphoma. 

Melanoma and Cutaneous Oncology

97-091.  A Phase I Study of Vaccination with Autologous, Lethally Irradiated Melanoma Cells Engineered by Adenoviral Mediated Gene Transfer to Secrete Human GM-CSF. 

00-069.  A Phase I/II Trial Investigation of the Safety and Immunogenicity of Adenoviruses Encoding Melan-a/MART-1 and gp100 Melanoma Antigens Administered Intradermally to Patients with Stage II-IV Melanoma. 

00-167.  An Open-Label Study of Anti-Cytotoxic T-Lymphocyte-Associated Antigen-4 (anti-CTLA-4) Monoclonal antibody (MDX-CTLA-4) in Patients with Surgically Unresectable Stage III or Stage IV Malignant Melanoma.

01-096.  Phase II Study of Melanoma Vaccine (NSC #683472/675756) and Low-Dose, Subcutaneous Interleukin-2 in Advanced Melanoma. 

01-228.  Anti-Cytotoxic T-Lymphocyte-Associated Antigen-4 (anti-CTLA-4) Humanized Monoclonal Antibody (MDX-CTLA-4) in Patients Previously Vaccinated with GM-CSF-Based Autologous Tumor Vaccines.

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. 

04-042.  A Phase I Trial of Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) and Gamma Interferon in Previously Vaccinated Patients. 


02-100.  A Phase I Study of Vaccination With Telomerase Peptide plus GM-CSF.  

03-365.  A Phase I Trial of Vaccination with Dynavax Technologies 1018 ISS, GM-CSF and Telomerase Peptide Vaccine.

Prostate Cancer

03-291.  A Phase II Randomized, Double-Blind, Controlled Study to Evaluate the Safety and Efficacy of PROSTVAC-VF/TRICOM in Combination with GM-CSF in Patient with Androgen-Independent Adenocarcinoma of the Prostate.