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NCT01580696 · ClinicalTrials.gov registry record · Phase 1
Phase I/IIa Trial of Folate Binding Protein Vaccine in Ovarian Cancer
A Phase 1 study, sponsored by COL George Peoples, MD, FACS.
- Completed
- Registry status
- Phase 1
- Development phase
- 51
- Enrollment target
NCT01580696: Completed Phase 1 study, sponsored by COL George Peoples, MD, FACS.
NCT01580696 is a Phase 1 study that has completed, run by COL George Peoples, MD, FACS. The registered enrollment target is 51 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (15% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01580696, a Phase 1 study, has completed, sponsored by COL George Peoples, MD, FACS.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 51 participants
- Enrollment target
Study Summary
Folate binding protein (FBP) is highly over-expressed in breast, ovarian and endometrial cancers and is the source of immunogenic peptides (E39) that can stimulate cytotoxic T lymphocytes (CTL) to recognize and destroy FBP-expressing cancer cells in the laboratory. The purpose of this study is to test whether a peptide-based vaccine consisting of the E39 peptide mixed with the FDA-approved immunoadjuvant granulocyte macrophage colony-stimulating factor (GM-CSF) is safe and effective at inducing an in vivo peptide-specific immune response. Furthermore, the investigators intend to determine the best dose of the vaccine to utilize to produce this immunity most efficiently. The investigators will determine whether immunity to FBP will prevent clinical recurrence. Additionally, the investigators will compare these results with results from a trial utilizing the E75 peptide (from the HER2/neu protein) in ovarian and endometrial cancer patients in preparation for studying a combination vaccine.
Primary Outcome
Standard local and systemic toxicities will be collected and graded per the National Cancer Institute Common Terminology Criteria for Adverse Events, v4.03 toxicity scale. For the vaccine series (one vaccine/month for six months), patients will be monitored closely for one hour after vaccine inoculation with questioning, serial exams and vital signs every 15 minutes to observe for a hypersensitivity reaction. Patients will also return to the clinic 48-72 hours after each inoculation for question
Interventions
- BIOLOGICAL E39 peptide (100mcg)/GM-CSF vaccine plus E39 booster
- OTHER Non-vaccine clinically matched control group
- BIOLOGICAL E39 peptide (500mcg)/GM-CSF vaccine plus E39 booster
- BIOLOGICAL E39 peptide (1000mcg)/GM-CSF vaccine plus E39 booster
- BIOLOGICAL E39 peptide (100mcg)/GM-CSF vaccine plus J65 booster
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 51 participants |
| Start Date | 2012-04 |
| Est. Completion | 2016-07-31 |
| Phase | Phase 1 |
What the finished NCT01580696 record still lists
NCT01580696 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 51 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (15% lower).
The record links to 0 conditions, and to 5 interventions - of which E39 peptide (100mcg)/GM-CSF vaccine plus E39 booster is the first listed.
NCT01580696 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01580696 about?
NCT01580696 is a clinical study titled "Phase I/IIa Trial of Folate Binding Protein Vaccine in Ovarian Cancer". Folate binding protein (FBP) is highly over-expressed in breast, ovarian and endometrial cancers and is the source of immunogenic peptides (E39) that can stimulate cytotoxic T lymphocytes (CTL) to recognize and destroy FBP-expressing cancer cells in the laboratory. The purpose of this study is to te...
What is the current status of trial NCT01580696?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 51 participants. The study started on 2012-04. Estimated completion is 2016-07-31.
What interventions are being tested in trial NCT01580696?
The interventions under investigation include: E39 peptide (100mcg)/GM-CSF vaccine plus E39 booster (BIOLOGICAL), Non-vaccine clinically matched control group (OTHER), E39 peptide (500mcg)/GM-CSF vaccine plus E39 booster (BIOLOGICAL), E39 peptide (1000mcg)/GM-CSF vaccine plus E39 booster (BIOLOGICAL), E39 peptide (100mcg)/GM-CSF vaccine plus J65 booster (BIOLOGICAL).
Who is sponsoring clinical trial NCT01580696?
This trial is sponsored by COL George Peoples, MD, FACS, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01580696's enrollment target sits among peer trials
51 969th of 2000 higher than 1,028 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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