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Sponsors and Collaborators: |
University of Pennsylvania Fox Chase Cancer Center |
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Information provided by: | University of Pennsylvania |
ClinicalTrials.gov Identifier: | NCT00478452 |
This is a randomized Phase I/II study designed to assess the induction of an anti-tumor immune response; the effect of cyclophosphamide on the vaccine; and to assess safety in subjects with advanced ovarian cancer or primary serous peritoneal cancer given a multivalent DC vaccine, with or without a single dose of cyclophosphamide. Potential benefit may range from no direct benefit to the study participants to stimulation of the subject's own immune system to attack ovarian cancer to prevent relapse.
Condition | Intervention | Phase |
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Ovarian Cancer |
Biological: DC-Ova |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Randomized Phase I/II Pilot Study of the Immunogenicity of Cyclophosphamide With Peptide Pulsed Mature Dendritic Cells for Patients With Previously Treated Ovarian Epithelial or Primary Peritoneal Carcinoma |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Disease Criteria. Patients will be eligible:
Patients with adequate organ function as measured by:
Exclusion Criteria:
United States, Pennsylvania | |
University of Pennsylvania | |
Philadelphia, Pennsylvania, United States, 19104 |
Principal Investigator: | Christina Chu, MD | University of Pennsylvania Hospital |
Responsible Party: | University of Pennsylvania ( Christina Chu, MD ) |
Study ID Numbers: | 707800, UPCC 01803 |
Study First Received: | May 22, 2007 |
Last Updated: | January 26, 2009 |
ClinicalTrials.gov Identifier: | NCT00478452 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Genital Diseases, Female Ovarian Neoplasms Gonadal Disorders Genital Neoplasms, Female Ovarian Cancer Endocrine System Diseases |
Urogenital Neoplasms Cyclophosphamide Endocrinopathy Ovarian Diseases Endocrine Gland Neoplasms Carcinoma |
Genital Diseases, Female Neoplasms Neoplasms by Site Ovarian Neoplasms Gonadal Disorders Genital Neoplasms, Female |
Endocrine System Diseases Urogenital Neoplasms Ovarian Diseases Adnexal Diseases Endocrine Gland Neoplasms |