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| Sponsor: | Abramson Cancer Center of the University of Pennsylvania |
|---|---|
| Information provided by (Responsible Party): | Abramson Cancer Center of the University of Pennsylvania |
| ClinicalTrials.gov Identifier: | NCT01132014 |
Purpose
This is a three cohort sequential clinical trial for subjects with recurrent ovarian, fallopian tube or primary peritoneal cancer to determine the feasibility and safety as well as immunogenicity of OC-DC, an autologous vaccine comprised of autologous dendritic cells (DC) loaded in vitro with lysate from autologous oxidized tumor cells, administered intranodally alone or in combination with intravenous Bevacizumab and Cyclophosphamide.
| Condition | Intervention | Phase |
|---|---|---|
|
Chemotherapy Tumor Ovarian Cancer |
Biological: OCDC |
Phase 0 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Primary Purpose: Treatment |
| Official Title: | A Pilot Clinical Trial of Dendritic Cell Vaccine Loaded With Autologous Tumor for Recurrent Ovarian, Primary Peritoneal or Fallopian Tube Cancer |
| Estimated Enrollment: | 15 |
| Study Start Date: | May 2010 |
| Estimated Study Completion Date: | May 2012 |
| Estimated Primary Completion Date: | May 2012 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Exclusion Criteria
Contacts and Locations| Contact: Clinical Team | 215-615-7447 | OCRC.Trials@uphs.upenn.edu |
| United States, Pennsylvania | |
| Abramson Cancer Center of the University of Pennsylvania | Recruiting |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Contact: Clinical Team 215-615-7447 OCRC.Trials@uphs.upenn.edu | |
| Principal Investigator: Janos Tanyi, MD | |
| Principal Investigator: | Janos Tanyi, MD | Abramson Cancer Center of the University of Pennsylvania |
More Information
| Responsible Party: | Abramson Cancer Center of the University of Pennsylvania |
| ClinicalTrials.gov Identifier: | NCT01132014 History of Changes |
| Other Study ID Numbers: | UPCC 19809 |
| Study First Received: | May 26, 2010 |
| Last Updated: | May 17, 2012 |
| Health Authority: | United States: Food and Drug Administration |
|
Subjects with recurrent ovarian, fallopian tube or primary peritoneal cancer, from whom solid tumor or ascites have been harvested and are available and sufficient for tumorlysate preparation;and whose largest tumor nodule is 4.5 cm. Subjects may have undergone chemotherapy or other therapy following tumor harvesting and prior to enrollment. |
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Ovarian Neoplasms Fallopian Tube Neoplasms Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Ovarian Diseases Adnexal Diseases |
Genital Diseases, Female Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders Fallopian Tube Diseases |