Journal ArticleDOI
Phase I Study of Non-Replicating Autologous Tumor Cell Injections Using Cells Prepared With or Without GM-CSF Gene Transduction in Patients with Metastatic Renal Cell Carcinoma
Investigators: Anton J. M. Berns,Shirley Clift,Lawrence K. Cohen,Ross C. Donehower,Glenn Dranoff,Karen M. Hauda,Elizabeth M. Jaffee,Audrey J. Lazenby,Hyam I. Levitsky,Fray F. Marshall,Richard C. Mulligan,William G. Nelson,Albert H. Owens,Drew M. Pardoll,Gordon Parry,Alan H. Partin,Steven Piantadosi,Jonathan W. Simons,James Zabora,Principal InvestigatorJonathan W. Simons +19 more
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This article is published in Human Gene Therapy.The article was published on 1995-03-01. It has received 85 citations till now. The article focuses on the topics: Autologous tumor cell & Transduction (genetics).read more
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A stable human-derived packaging cell line for production of high titer retrovirus/vesicular stomatitis virus G pseudotypes
TL;DR: A human 293-derived retroviral packaging cell line (293GPG) capable of producing high titers of recombinant Moloney murine leukemia virus particles that have incorporated the vesicular stomatitis virus G (VSV-G) protein is generated.
Journal Article
Induction of immunity to prostate cancer antigens: results of a clinical trial of vaccination with irradiated autologous prostate tumor cells engineered to secrete granulocyte-macrophage colony-stimulating factor using ex vivo gene transfer
Jonathan W. Simons,Bahar Mikhak,Ju-Fay Chang,Angelo M. DeMarzo,Michael A. Carducci,Michael Lim,Christine E. Weber,Angelo A. Baccala Md,Marti Goemann,Shirley M. Clift,Dale G. Ando,Hyam I. Levitsky,Lawrence K. Cohen,Martin G. Sanda,Richard C. Mulligan,Alan W. Partin,H. Ballentine Carter,Steven Piantadosi,Fray F. Marshall,William G. Nelson +19 more
TL;DR: It is suggested that both T-cell and B-cell immune responses to human PCA can be generated by treatment with irradiated, GM-CSF gene-transduced PCA vaccines, and side effects were pruritus, erythema, and swelling at vaccination sites.
Journal Article
Bioactivity of Autologous Irradiated Renal Cell Carcinoma Vaccines Generated by ex Vivo Granulocyte-Macrophage Colony-stimulating Factor Gene Transfer
Jonathan W. Simons,Elizabeth M. Jaffee,Christine E. Weber,Hyam I. Levitsky,William G. Nelson,Michael A. Carducci,Audrey J. Lazenby,Lawrence K. Cohen,Christy C. Finn,Shirley M. Clift,Karen M. Hauda,Lisa A. Beck,Kristin M. Leiferman,Albert H. Owens,Steven Piantadosi,Glenn Dranoff,Richard C. Mulligan,Drew M. Pardoll,Fray F. Marshall +18 more
TL;DR: This Phase I study demonstrated the feasibility, safety, and bioactivity of an autologous GM-CSF gene-transduced tumor vaccine for RCC patients.
Journal ArticleDOI
Demonstration of a Rational Strategy for Human Prostate Cancer Gene Therapy
Martin G. Sanda,Martin G. Sanda,Sujatha R. Ayyagari,Sujatha R. Ayyagari,Elizabeth M. Jaffee,Elizabeth M. Jaffee,Jonathan I. Epstein,Jonathan I. Epstein,Shirley Clift,Shirley Clift,Lawrence K. Cohen,Lawrence K. Cohen,Glenn Dranoff,Glenn Dranoff,Drew M. Pardoll,Drew M. Pardoll,Richard C. Mulligan,Richard C. Mulligan,Jonathan W. Simons,Jonathan W. Simons +19 more
TL;DR: These studies show a preclinical basis for proceeding with clinical trials of gene therapy for human prostate cancer, and demonstrate that increased gene dose can be used to escalate desired gene expression in individual patients.
Journal ArticleDOI
Glioma immunology and immunotherapy.
TL;DR: Key aspects of modern immunology are explored, including immunogene therapy, directed cytokine delivery, and dendritic cell manipulation, which suggest that glioma-derived immunosuppression can be overcome.
References
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Journal ArticleDOI
Continual reassessment method: a practical design for phase 1 clinical trials in cancer.
TL;DR: A new approach to the design and analysis of Phase 1 clinical trials in cancer and a particularly simple model is looked at that enables the use of models whose only requirements are that locally they reasonably well approximate the true probability of toxic response.
Journal ArticleDOI
Design and analysis of phase I clinical trials.
TL;DR: In Monte Carlo simulations, two two-stage designs are found to provide reduced bias in maximum likelihood estimation of the MTD in less than ideal dose-response settings and several designs to be nearly as conservative as the standard design in terms of the proportion of patients entered at higher dose levels.
Journal ArticleDOI
Effect of Recombinant Human Granulocyte-Macrophage Colony-Stimulating Factor on Hematopoietic Reconstitution after High-Dose Chemotherapy and Autologous Bone Marrow Transplantation
Stephen J. Brandt,William P. Peters,Susan K. Atwater,Joanne Kurtzberg,Michael J. Borowitz,Roy B. Jones,Elizabeth J. Shpall,Robert C. Bast,Colleen J. Gilbert,Dagmar Oette +9 more
TL;DR: It is indicated that rHuGM-CSF can accelerate myeloid recovery after high-dose chemotherapy and autologous bone marrow transplantation, over a range of doses that can be tolerated.
Journal ArticleDOI
Recombinant Granulocyte-Macrophage Colony-Stimulating Factor after Autologous Bone Marrow Transplantation for Lymphoid Cancer
John Nemunaitis,John Nemunaitis,John Nemunaitis,SN Rabinowe,Jack W. Singer,Jack W. Singer,Jack W. Singer,Philip J. Bierman,Julie M. Vose,Arnold S. Freedman,Nicole Onetto,S Gillis,Dagmar Oette,Morris S. Gold,C. Dean Buckner,C. Dean Buckner,John A. Hansen,John A. Hansen,Jerome Ritz,Frederick R. Appelbaum,Frederick R. Appelbaum,James O. Armitage,Lee M. Nadler +22 more
TL;DR: The patients given rhGM-CSF had a recovery of the neutrophil count to 500×106 per liter 7 days earlier than the patients who received placebo, suggesting that recombinant human granulocytemacrophage colony-stimulating factor may accelerate neutrophIL recovery and thereby reduce complications in patients after autologous bone marrow transplantation.
Journal ArticleDOI
Methods for dose finding studies in cancer clinical trials: a review and results of a Monte Carlo study.
John O'Quigley,Sylvie Chevret +1 more
TL;DR: It appears that the continual reassessment method is preferable to other contending schemes.