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Sponsors and Collaborators: |
University of Pennsylvania Northwest Biotherapeutics |
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Information provided by: | University of Pennsylvania |
ClinicalTrials.gov Identifier: | NCT00603460 |
Subjects with recurrent epithelial ovarian carcinoma or primary peritoneal cancer, who have previously undergone vaccination in clinical study UPCC-11807 with DCVax-L, an autologous vaccine with DC loaded in vitro with autologous tumor lysate.
Phase I Subjects enrolled in this study will receive leukapheresis; followed by cyclophosphamide/fludarabine-induced lymphodepletion; followed by adoptive transfer of ex vivo CD3/CD28-costimulated vaccine-primed peripheral blood autologous T cells; followed by a single DCVax-L vaccination, to establish feasibility and safety of this approach.
Primary Objectives of Phase I
To determine the feasibility and safety of administering vaccine-primed, ex vivo CD3/CD28-costimulated autologous peripheral blood T cells in combination with DCVax-L vaccination, following lymphodepletion with high dose cyclophosphamide/fludarabine.
Phase II
Twenty-two additional subjects will be randomized to receive either:
Primary Objective of Phase II
To assess the distribution of progression-free survival at 6 months for patients treated with maintenance DCVax-L vaccination plus oral metronomic cyclophosphamide as well as patients treated with ex vivo CD3/CD28-costimulated vaccine-primed peripheral blood autologous T cells after lymphodepletion with high dose cyclophosphamide / fludarabine, followed by DCVax-L boost vaccination and metronomic oral cyclophosphamide.
Condition | Intervention | Phase |
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Ovarian Cancer Primary Peritoneal Cancer |
Biological: DCVax-L and T Cells |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase-I/II Randomized Trial of Maintenance Vaccination Combined With Metronomic Cyclophosphamide w/wo Adoptive Transfer of CD3/CD28-CoStimulated T-Cells for Recurrent Ovarian or Primary Peritoneal Cancer Previously Vaccinated DCVax-L |
Estimated Enrollment: | 13 |
Study Start Date: | May 2008 |
Estimated Study Completion Date: | March 2010 |
Estimated Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Active Comparator |
Biological: DCVax-L and T Cells
Arm A
Arm B
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B: Active Comparator |
Biological: DCVax-L and T Cells
Arm A
Arm B
|
Description of treatment for Phase I:
Description of treatment for Phase II:
In ARM-IIA:
In ARM-IIB:
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Pennsylvania | |
University of Pennsylania | |
Philadelphia, Pennsylvania, United States, 19104 |
Principal Investigator: | George Coukos, M.D., Ph.D. | University of Pennsylvania |
Responsible Party: | University of Philadelphia ( Carl H. June, M.D. / Professor ) |
Study ID Numbers: | UPCC 08108 |
Study First Received: | January 16, 2008 |
Last Updated: | May 7, 2008 |
ClinicalTrials.gov Identifier: | NCT00603460 |
Health Authority: | United States: Food and Drug Administration |
Ovarian Cancer Peritoneal Cancer |
Ovarian cancer Ovarian Neoplasms Digestive System Neoplasms Gonadal Disorders Genital Neoplasms, Female Endocrine System Diseases Urogenital Neoplasms Bevacizumab Fludarabine monophosphate Cyclophosphamide Ovarian Diseases |
Abdominal Neoplasms Recurrence Genital Diseases, Female Digestive System Diseases Peritoneal Diseases Gastrointestinal Neoplasms Fludarabine Endocrinopathy Peritoneal Neoplasms Endocrine Gland Neoplasms |
Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Immunosuppressive Agents Pharmacologic Actions Adnexal Diseases |
Neoplasms Neoplasms by Site Therapeutic Uses Myeloablative Agonists Antineoplastic Agents, Alkylating Antirheumatic Agents Alkylating Agents |