Trial · NCT00091273
Vaccine Therapy in Treating Patients With Ovarian Epithelial or Primary Peritoneal Cancer
NCT00091273, Phase 1, Completed, University of Virginia; results first posted 2014-06-20
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Vaccine Therapy in Treating Patients With Ovarian Epithelial or Primary Peritoneal Cancer. Trials, record NCT00091273. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00091273
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Vaccine Therapy in Treating Patients With Ovarian Epithelial or Primary Peritoneal Cancer
- NCT number
- NCT00091273
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 9 participants, actual
- Lead sponsor
- University of Virginia
- Conditions
- Ovarian Cancer, Primary Peritoneal Cavity Cancer
- Interventions
- incomplete Freund's adjuvant, ovarian cancer peptide vaccine, sargramostim, tetanus toxoid helper peptide, adjuvant therapy
- First posted
- 2004-09-09
- Last updated
- 2014-06-20
- Results first posted
- 2014-06-20
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Safety of the Vaccine | Days 1,8,15,22,29,36,43,50 | Participants kept a toxicity diary during the time frame of interest which was reviewed with a study clinician at each visit. |
| Primary | Measure of Tumor-antigen-specific Immunity in SIN by ELIspot Assay | Day 22 | |
| Secondary | Measure of Tumor-antigen-specific Immunity in PBMC by Elispot Assay | Days 1,8,15,22,29,36,43,50 and Month 3 |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Safety of the Vaccine | Days 1,8,15,22,29,36,43,50 | All treated subjects were assessed. | participants | NUMBER |
| PRIMARY | Measure of Tumor-antigen-specific Immunity in SIN by ELIspot Assay | Day 22 | All treated subjects were assessed. | participants | NUMBER |
| SECONDARY | Measure of Tumor-antigen-specific Immunity in PBMC by Elispot Assay | Days 1,8,15,22,29,36,43,50 and Month 3 | All treated subjects were assessed. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Safety of the Vaccine | Single Arm | # of Subjects Experiencing a DLT | 0 | participants | |
| Safety of the Vaccine | Single Arm | # of Subjects Not Experiencing a DLT | 9 | participants | |
| Measure of Tumor-antigen-specific Immunity in SIN by ELIspot Assay | Single Arm | Responders | 8 | participants | |
| Measure of Tumor-antigen-specific Immunity in SIN by ELIspot Assay | Single Arm | Non-responders | 1 | participants | |
| Measure of Tumor-antigen-specific Immunity in PBMC by Elispot Assay | Single Arm | Responders | 8 | participants | |
| Measure of Tumor-antigen-specific Immunity in PBMC by Elispot Assay | Single Arm | Non-responders | 1 | participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Single Arm | 9 | |
| Overall Study | COMPLETED | Single Arm | 9 | |
| Overall Study | NOT COMPLETED | Single Arm | 0 |
Source ClinicalTrials.gov
Adverse events35
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Autoimmune Reaction | Immune system disorders | Single Arm | 2 | 9 | |
| other | Hemoglobin | Blood and lymphatic system disorders | Single Arm | 4 | 9 | |
| other | Leukocytes | Blood and lymphatic system disorders | Single Arm | 1 | 9 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Single Arm | 2 | 9 | |
| other | Fatigue | General disorders | Single Arm | 7 | 9 | |
| other | Fever | General disorders | Single Arm | 1 | 9 | |
| other | Rigors/Chills | General disorders | Single Arm | 2 | 9 | |
| other | Sweating | General disorders | Single Arm | 2 | 9 | |
| other | Bruising | Skin and subcutaneous tissue disorders | Single Arm | 2 | 9 | |
| other | Flushing | Skin and subcutaneous tissue disorders | Single Arm | 2 | 9 |
1 to 10 of 35Source ClinicalTrials.gov
See all 35 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Single Arm | ||
| Total, other adverse events | Single Arm | 9 | 9 |
| Total, serious adverse events | Single Arm | 0 | 9 |
Source ClinicalTrials.gov
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/NCT00091273
GET https://conductscience.org/api/trials/v1/NCT00091273/events?page=2