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NCT01312389 · ClinicalTrials.gov registry record · Phase 1
A Clinical Trial of Autologous Oxidized Tumor Cell Lysate Vaccine For Recurrent Ovarian, Fallopian Tube or Primary Peritoneal Cancer
A Phase 1 study, sponsored by Abramson Cancer Center at Penn Medicine.
- Terminated
- Registry status
- Phase 1
- Development phase
- 3
- Enrollment target
NCT01312389: Clinical Trial Phase 1 study, sponsored by Abramson Cancer Center at Penn Medicine.
NCT01312389 is a Phase 1 study that was terminated before completion, run by Abramson Cancer Center at Penn Medicine. The registered enrollment target is 3 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01312389, a Phase 1 study, was terminated before completion, sponsored by Abramson Cancer Center at Penn Medicine.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 3 participants
- Enrollment target
Study Summary
This is a Phase I/II randomized study for subjects with recurrent ovarian, fallopian tube or primary peritoneal cancer to determine the feasibility and safety as well as immunogenicity of OC-L, an autologous vaccine comprised of autologous Oxidized tumor Cell Lysate (OC-L) administered by intradermal/subcutaneous injection in combination with Ampligen (poly-l:poly-C12U), a Toll-like receptor 3 agonist. Study duration is 24 months.
Primary Outcome
Safety will be established by grading the observed toxicities using the NCI Common Toxicity Criteria (CTC Version 4.0). All toxicities observed within 30 days of last vaccination will be included. All patients that receive at least one vaccination will be included in the toxicity analysis.
Interventions
- BIOLOGICAL Prevnar
- BIOLOGICAL OC-L/Montanide ISA 51 VG
- BIOLOGICAL Ampligen
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2011-04 |
| Est. Completion | 2012-08-17 |
| Phase | Phase 1 |
Why NCT01312389 stopped before completion
NCT01312389 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 3 interventions - of which Prevnar is the first listed.
NCT01312389 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01312389 about?
NCT01312389 is a clinical study titled "A Clinical Trial of Autologous Oxidized Tumor Cell Lysate Vaccine For Recurrent Ovarian, Fallopian Tube or Primary Peritoneal Cancer". This is a Phase I/II randomized study for subjects with recurrent ovarian, fallopian tube or primary peritoneal cancer to determine the feasibility and safety as well as immunogenicity of OC-L, an autologous vaccine comprised of autologous Oxidized tumor Cell Lysate (OC-L) administered by intraderma...
What is the current status of trial NCT01312389?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 3 participants. The study started on 2011-04. Estimated completion is 2012-08-17.
What interventions are being tested in trial NCT01312389?
The interventions under investigation include: Prevnar (BIOLOGICAL), OC-L/Montanide ISA 51 VG (BIOLOGICAL), Ampligen (BIOLOGICAL).
Who is sponsoring clinical trial NCT01312389?
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 NCT01312389's enrollment target sits among peer trials
3 1999th of 2000 higher than 1 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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