Autologous OC-DC Vaccine in Ovarian Cancer
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ClinicalTrials.gov Identifier: NCT01132014 |
Recruitment Status :
Completed
First Posted : May 27, 2010
Last Update Posted : June 11, 2018
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Sponsor:
Abramson Cancer Center at Penn Medicine
Information provided by (Responsible Party):
Abramson Cancer Center at Penn Medicine
Tracking Information | |||
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First Submitted Date ICMJE | May 26, 2010 | ||
First Posted Date ICMJE | May 27, 2010 | ||
Last Update Posted Date | June 11, 2018 | ||
Study Start Date ICMJE | May 2010 | ||
Actual Primary Completion Date | May 30, 2018 (Final data collection date for primary outcome measure) | ||
Current Primary Outcome Measures ICMJE |
Safety [ Time Frame: 30 days of last vaccination ] Safety will be established by grading the observed toxicities using the NCI Common Toxicity Criteria (CTC Version3.0). All toxicities observed within 30 days of last vaccination will be included.
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Original Primary Outcome Measures ICMJE | Same as current | ||
Change History | |||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||
Original Other Pre-specified Outcome Measures | Not Provided | ||
Descriptive Information | |||
Brief Title ICMJE | Autologous OC-DC Vaccine in Ovarian Cancer | ||
Official Title ICMJE | A Pilot Clinical Trial of Dendritic Cell Vaccine Loaded With Autologous Tumor for Recurrent Ovarian, Primary Peritoneal or Fallopian Tube Cancer | ||
Brief Summary | This is a Five 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 or in combination with intravenous Bevacizumab, cyclophosphamide and aspirin. Study duration is 24 months. | ||
Detailed Description | Not Provided | ||
Study Type ICMJE | Interventional | ||
Study Phase ICMJE | Early Phase 1 | ||
Study Design ICMJE | Primary Purpose: Treatment | ||
Condition ICMJE |
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Intervention ICMJE | Biological: OCDC
OCDC,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 either intravenous Daclizumab, or with a combination of Daclizumab and intravenous Bevacizumab.
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Study Arms ICMJE | Not Provided | ||
Publications * | Chiang CL, Maier DA, Kandalaft LE, Brennan AL, Lanitis E, Ye Q, Levine BL, Czerniecki BJ, Powell DJ Jr, Coukos G. Optimizing parameters for clinical-scale production of high IL-12 secreting dendritic cells pulsed with oxidized whole tumor cell lysate. J Transl Med. 2011 Nov 14;9:198. doi: 10.1186/1479-5876-9-198. | ||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||
Recruitment Status ICMJE | Completed | ||
Actual Enrollment ICMJE |
67 | ||
Original Estimated Enrollment ICMJE |
30 | ||
Actual Study Completion Date ICMJE | May 30, 2018 | ||
Actual Primary Completion Date | May 30, 2018 (Final data collection date for primary outcome measure) | ||
Eligibility Criteria ICMJE | Inclusion Criteria Subject has recurrent ovarian (including low malignant potential), fallopian tube, or primary peritoneal cancer.
EXCLUSION CRITERIA
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||
Accepts Healthy Volunteers ICMJE | No | ||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||
Listed Location Countries ICMJE | United States | ||
Removed Location Countries | |||
Administrative Information | |||
NCT Number ICMJE | NCT01132014 | ||
Other Study ID Numbers ICMJE | UPCC 19809 | ||
Has Data Monitoring Committee | Yes | ||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||
Current Responsible Party | Abramson Cancer Center at Penn Medicine | ||
Original Responsible Party | George Coukos, MD, Abramson Cancer Center of the University of Pennsylvania | ||
Current Study Sponsor ICMJE | Abramson Cancer Center at Penn Medicine | ||
Original Study Sponsor ICMJE | Same as current | ||
Collaborators ICMJE | Not Provided | ||
Investigators ICMJE | Not Provided | ||
PRS Account | Abramson Cancer Center at Penn Medicine | ||
Verification Date | April 2018 | ||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |