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NCT01312376 · ClinicalTrials.gov registry record · Phase 1
Autologous T-Cells Combined With Autologous OC-DC Vaccine in Ovarian Cancer
A Phase 1 study, sponsored by Abramson Cancer Center at Penn Medicine.
- Terminated
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
NCT01312376: Clinical Trial Phase 1 study, sponsored by Abramson Cancer Center at Penn Medicine.
NCT01312376 is a Phase 1 study that was terminated before completion, run by Abramson Cancer Center at Penn Medicine. The registered enrollment target is 18 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01312376, a Phase 1 study, was terminated before completion, sponsored by Abramson Cancer Center at Penn Medicine.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
Study Summary
This is a phase-I clinical trial to determine the feasibility and safety of Cyclophosphamide/Fludarabine Lymphodepletion and an immunomodulatory combination of Interferon-alpha Bevacizumab and Aspirin followed by adoptive transfer of vaccine-primed ex vivo CD3/CD28-costimulated peripheral blood autologous T cells and vaccination with whole tumor vaccine administered intradermally in combination with Bevacizumab in patients with recurrent ovarian cancer fallopian tube or primary peritoneal cancer. (Funding Source - FDA OOPD)
Primary Outcome
Dose limiting toxicity is defined as the occurrence of treatment-related adverse events.
Interventions
- DRUG Bevacizumab
- BIOLOGICAL OC-DC vaccine
- DRUG cyclophosphamide 300 mg/m2/d for 3 days
- DRUG fludarabine 30 mg/m2/d for 3 days
- DRUG ex vivo CD3/CD28-costimulated vaccine-primed peripheral blood autologous T cells
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2011-03 |
| Est. Completion | 2019-01 |
| Phase | Phase 1 |
Why NCT01312376 stopped before completion
NCT01312376 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower).
The record links to 0 conditions, and to 5 interventions - of which Bevacizumab is the first listed.
NCT01312376 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01312376 about?
NCT01312376 is a clinical study titled "Autologous T-Cells Combined With Autologous OC-DC Vaccine in Ovarian Cancer". This is a phase-I clinical trial to determine the feasibility and safety of Cyclophosphamide/Fludarabine Lymphodepletion and an immunomodulatory combination of Interferon-alpha Bevacizumab and Aspirin followed by adoptive transfer of vaccine-primed ex vivo CD3/CD28-costimulated peripheral blood auto...
What is the current status of trial NCT01312376?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2011-03. Estimated completion is 2019-01.
What interventions are being tested in trial NCT01312376?
The interventions under investigation include: Bevacizumab (DRUG), OC-DC vaccine (BIOLOGICAL), cyclophosphamide 300 mg/m2/d for 3 days (DRUG), fludarabine 30 mg/m2/d for 3 days (DRUG), ex vivo CD3/CD28-costimulated vaccine-primed peripheral blood autologous T cells (DRUG).
Who is sponsoring clinical trial NCT01312376?
This trial is sponsored by Abramson Cancer Center at Penn Medicine, which has 402 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01312376's enrollment target sits among peer trials
18 1720th of 2000 higher than 216 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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