Trial · NCT01580696
Phase I/IIa Trial of Folate Binding Protein Vaccine in Ovarian Cancer
NCT01580696, Phase 1, Phase 2, Completed, COL George Peoples, MD, FACS
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Phase I/IIa Trial of Folate Binding Protein Vaccine in Ovarian Cancer. Trials, record NCT01580696. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01580696
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase I/IIa Trial of Folate Binding Protein Vaccine in Ovarian Cancer
- NCT number
- NCT01580696
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 51 participants, actual
- Lead sponsor
- COL George Peoples, MD, FACS
- Conditions
- Ovarian Cancer, Endometrial Cancer, Fallopian Cancer, Peritoneal Cancer
- Interventions
E39 peptide (100mcg)/GM-CSF vaccine plus E39 booster, Non-vaccine clinically matched control group, E39 peptide (500mcg)/GM-CSF vaccine plus E39 booster, E39 peptide (1000mcg)/GM-CSF vaccine plus E39 booster, E39 peptide (100mcg)/GM-CSF vaccine plus J65 booster, E39 peptide (500mcg)/GM-CSF vaccine plus J65 booster, E39 peptide (1000mcg)/GM-CSF vaccine plus J65 booster
- First posted
- 2012-04-19
- Last updated
- 2020-05-04
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Safety and Local/Systemic Toxicity | Duration of the vaccine series | 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 questioning regarding systemic toxicity and to examine and measure inoculation site local reactions. |
| Secondary | Disease-free survival | Disease-free survival up to 36 months | Disease-free survival (DFS) for all patients regardless of randomization will be determined by the patients' own physicians at the individual study sites during routine follow-up screening. This will occur every three months for the first 24 months after diagnosis and then every six months for an additional 36 months. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01580696
GET https://conductscience.org/api/trials/v1/NCT01580696/registered