Trial · NCT00088413
PANVAC-V and PANVAC-F Vaccines Plus Sargramostim to Treat Advanced Cancer
NCT00088413, Phase 1, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2019-04-16
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. PANVAC-V and PANVAC-F Vaccines Plus Sargramostim to Treat Advanced Cancer. Trials, record NCT00088413. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00088413
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- PANVAC-V and PANVAC-F Vaccines Plus Sargramostim to Treat Advanced Cancer
- NCT number
- NCT00088413
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 51 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Adenocarcinoma, Colorectal Cancer, Ovarian Cancer, Breast Cancer
- Interventions
- PANVAC-V, PANVAC-F, Sargramostim (GM-CSF, Leukine)
- First posted
- 2004-07-26
- Last updated
- 2019-04-16
- Results first posted
- 2019-04-16
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Complete Responses (CRs), Partial Responses (PRs,) Stable Disease and Progressive Disease in the Ovarian Cancer and Breast Cancer Cohorts | Approximately 6 months while on trial | Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete Response is disappearance of all clinical and laboratory signs and symptoms of disease for a minimum of 4 weeks during which no new lesions may appear. Partial Response is a minimum of 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter. Stable disease is neither sufficient shrinkage to qualify for partial response nor progressive disease, taking as reference the smallest sum longest diameter since the treatment started. Progressive disease is a minimum of 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new measurable lesions. |
| Primary | Percentage of Vaccines Associated With Grade 1 and Grade 2 Adverse Events Related to Vaccine in the Colorectal Cancer and Non-Colorectal Cancer Arm/Group | Approximately 6 months while on trial | Grade 1 (mild) and Grade 2 (moderate) adverse events were assessed by the Common Terminology Criteria in Adverse Events (CTCAE) v3.0 if reported prior to August 1, 2010 and CTCAE v4.0 if reported after. A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. |
| Secondary | Percentage of Participants With Grade 1 and Grade 2 Adverse Events Possibly, Likely, or Definitely Related to Vaccine in the Breast Cancer and Ovarian Cancer Cohorts | Approximately 2 months while on trial | Vaccines were administered to participants and Grade 1 (mild) and Grade 2 (moderate) adverse events were assessed by the Common Terminology Criteria in Adverse Events (CTCAE) v3.0 if reported prior to August 1, 2010 and CTCAE v4.0 if reported after. Common Terminology Criteria in Adverse Events. A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. |
| Secondary | Number of Participants With Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE) v3.0 and v4.0 | Date consent signed to date off study, approximately 164 months and 10 days | Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE) v3.0 if reported prior to August 1, 2010 and CTCAE v4.0 if reported after. A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. |
| Secondary | Number of Participants With an Positive Immune Response to Carcinoembryonic Antigen (CEA) Peptide and/or Protein in the Colorectal Cancer and Non-colorectal Cancer Cohort Post Vaccination | post vaccination (up to Day 84) | Immune response in human leukocyte antigens (HLA)-A2 positive patients to carcinoembryonic antigen (CEA) was assessed by enzyme-linked immunospot assay (ELISPOT) analysis. A positive immune response was defined as a \>2x fold increase in the number of interferon gamma producing cells. |
| Secondary | Number of Participants With an Positive Immune Response to Carcinoembryonic Antigen (CEA) Peptide and/or Protein in the Breast Cancer and Ovarian Cancer Cohorts Post Vaccination | post vaccination (up to Day 84) | Immune response in human leukocyte antigens (HLA)-A2 positive patients to carcinoembryonic antigen (CEA) was assessed by enzyme-linked immunospot assay (ELISPOT) analysis. A positive immune response was defined as a \>2x fold increase in the number of interferon gamma producing cells. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Complete Responses (CRs), Partial Responses (PRs,) Stable Disease and Progressive Disease in the Ovarian Cancer and Breast Cancer Cohorts | Approximately 6 months while on trial | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Percentage of Vaccines Associated With Grade 1 and Grade 2 Adverse Events Related to Vaccine in the Colorectal Cancer and Non-Colorectal Cancer Arm/Group | Approximately 6 months while on trial | The colorectal and non-colorectal cohorts received the same treatment on the same schedule, had no immune dysfunction at baseline and are biologically equivalent. For rare events in small cohorts, a better estimate of the true event rate is determined by grouping similar patients and is consistent with the peer-reviewed clinical paper. | Percentage of vaccines | NUMBER |
| SECONDARY | Percentage of Participants With Grade 1 and Grade 2 Adverse Events Possibly, Likely, or Definitely Related to Vaccine in the Breast Cancer and Ovarian Cancer Cohorts | Approximately 2 months while on trial | The breast and ovarian cohorts received the same treatment on the same schedule, had no evidence of immune dysfunction at baseline and are biologically equivalent. For rare events that occur in small trial arms, the true event rate is better determined by grouping similar patients and is consistent with the peer-reviewed clinical paper. | percentage of participants | NUMBER |
| SECONDARY | Number of Participants With Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE) v3.0 and v4.0 | Date consent signed to date off study, approximately 164 months and 10 days | Pts in these 2 cohorts rec'd the same treatment, have absence of immune dysfunction at baseline and are biologically equivalent. For rare events that occur in small cohorts, a better est. of the true event rate can be determined by grouping the pts in the absence of a biological rationale and is consistent with the peer-reviewed clinical paper. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With an Positive Immune Response to Carcinoembryonic Antigen (CEA) Peptide and/or Protein in the Colorectal Cancer and Non-colorectal Cancer Cohort Post Vaccination | post vaccination (up to Day 84) | Overall number of participants analyzed reflects participants that are HLA-A2 positive. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With an Positive Immune Response to Carcinoembryonic Antigen (CEA) Peptide and/or Protein in the Breast Cancer and Ovarian Cancer Cohorts Post Vaccination | post vaccination (up to Day 84) | Only 3 Breast Cancer and 2 Ovarian Cancer patients had enough blood collected to perform enzyme-linked immunospot (ELISPOT) analysis. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group27
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Complete Responses (CRs), Partial Responses (PRs,) Stable Disease and Progressive Disease in the Ovarian Cancer and Breast Cancer Cohorts | Breast Cancer Cohort | Complete Response | 1 | Participants | |
| Number of Participants With Complete Responses (CRs), Partial Responses (PRs,) Stable Disease and Progressive Disease in the Ovarian Cancer and Breast Cancer Cohorts | Ovarian Cancer Cohort | Complete Response | 0 | Participants | |
| Number of Participants With Complete Responses (CRs), Partial Responses (PRs,) Stable Disease and Progressive Disease in the Ovarian Cancer and Breast Cancer Cohorts | Breast Cancer Cohort | Partial Response | 0 | Participants | |
| Number of Participants With Complete Responses (CRs), Partial Responses (PRs,) Stable Disease and Progressive Disease in the Ovarian Cancer and Breast Cancer Cohorts | Ovarian Cancer Cohort | Partial Response | 0 | Participants | |
| Number of Participants With Complete Responses (CRs), Partial Responses (PRs,) Stable Disease and Progressive Disease in the Ovarian Cancer and Breast Cancer Cohorts | Breast Cancer Cohort | Stable Disease | 4 | Participants | |
| Number of Participants With Complete Responses (CRs), Partial Responses (PRs,) Stable Disease and Progressive Disease in the Ovarian Cancer and Breast Cancer Cohorts | Ovarian Cancer Cohort | Stable Disease | 3 | Participants | |
| Number of Participants With Complete Responses (CRs), Partial Responses (PRs,) Stable Disease and Progressive Disease in the Ovarian Cancer and Breast Cancer Cohorts | Breast Cancer Cohort | Progressive Disease | 7 | Participants | |
| Number of Participants With Complete Responses (CRs), Partial Responses (PRs,) Stable Disease and Progressive Disease in the Ovarian Cancer and Breast Cancer Cohorts | Ovarian Cancer Cohort | Progressive Disease | 11 | Participants | |
| Percentage of Vaccines Associated With Grade 1 and Grade 2 Adverse Events Related to Vaccine in the Colorectal Cancer and Non-Colorectal Cancer Arm/Group | Colorectal Cancer and Non-Colorectal Cancer Cohort | Injection-site reaction | 88 | Percentage of vaccines | |
| Percentage of Vaccines Associated With Grade 1 and Grade 2 Adverse Events Related to Vaccine in the Colorectal Cancer and Non-Colorectal Cancer Arm/Group | Colorectal Cancer and Non-Colorectal Cancer Cohort | Fatigue | 5 | Percentage of vaccines |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Colorectal Cancer Cohort | 10 | |
| Overall Study | STARTED | Non-Colorectal Cancer Cohort | 15 | |
| Overall Study | STARTED | Breast Cohort | 12 | |
| Overall Study | STARTED | Ovarian Cohort | 14 | |
| Overall Study | COMPLETED | Colorectal Cancer Cohort | 0 | |
| Overall Study | COMPLETED | Non-Colorectal Cancer Cohort | 0 | |
| Overall Study | COMPLETED | Breast Cohort | 0 | |
| Overall Study | COMPLETED | Ovarian Cohort | 0 | |
| Overall Study | NOT COMPLETED | Colorectal Cancer Cohort | 10 | |
| Overall Study | NOT COMPLETED | Non-Colorectal Cancer Cohort | 15 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events718
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 | ALLERGY/IMMUNOLOGY:: Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)*3 | Immune system disorders | Colorectal Cancer vs Non-Colorectal Cancer Cohort | 2 | 25 | 4 |
| other | ALLERGY/IMMUNOLOGY:: Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)*3 | Immune system disorders | Breast and Ovarian Cohorts | 1 | 26 | 2 |
| other | Activated partial thromboplastin time prolonged*4 | Investigations | Colorectal Cancer vs Non-Colorectal Cancer Cohort | 0 | 25 | 0 |
| other | Activated partial thromboplastin time prolonged*4 | Investigations | Breast and Ovarian Cohorts | 4 | 26 | 6 |
| other | Alanine aminotransferase increased*4 | Investigations | Colorectal Cancer vs Non-Colorectal Cancer Cohort | 0 | 25 | 0 |
| other | Alanine aminotransferase increased*4 | Investigations | Breast and Ovarian Cohorts | 1 | 26 | 1 |
| other | Alkaline phosphatase increased*4 | Investigations | Colorectal Cancer vs Non-Colorectal Cancer Cohort | 0 | 25 | 0 |
| other | Alkaline phosphatase increased*4 | Investigations | Breast and Ovarian Cohorts | 1 | 26 | 1 |
| other | Allergic reaction*4 | Immune system disorders | Colorectal Cancer vs Non-Colorectal Cancer Cohort | 0 | 25 | 0 |
| other | Allergic reaction*4 | Immune system disorders | Breast and Ovarian Cohorts | 1 | 26 | 1 |
1 to 10 of 718Source ClinicalTrials.gov
See all 718 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Colorectal Cancer vs Non-Colorectal Cancer Cohort | 1 | 25 |
| Total, all-cause mortality | Breast and Ovarian Cohorts | 0 | 26 |
| Total, other adverse events | Colorectal Cancer vs Non-Colorectal Cancer Cohort | 25 | 25 |
| Total, other adverse events | Breast and Ovarian Cohorts | 26 | 26 |
| Total, serious adverse events | Colorectal Cancer vs Non-Colorectal Cancer Cohort | 25 | 25 |
| Total, serious adverse events | Breast and Ovarian Cohorts | 26 | 26 |
Source ClinicalTrials.gov
Papers5
The papers the trial lists on ClinicalTrials.gov.
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 comparisons5
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
Breast Cancer Cohort vs Ovarian Cancer Cohort: Number of Participants With an Positive Immune Response to Carcinoembryonic Antigen (CEA) Peptide and/or Protein in the Breast Cancer and Ovarian Cancer Cohorts Post Vaccination | Trial comparisons |
Colorectal Cancer Cohort vs Non-Colorectal Cancer Cohort: Number of Participants With an Positive Immune Response to Carcinoembryonic Antigen (CEA) Peptide and/or Protein in the Colorectal Cancer and Non-colorectal Cancer Cohort Post Vaccination | Trial comparisons |
| Colorectal Cancer vs Non-Colorectal Cancer Cohort vs Breast and Ovarian Cohorts: deaths from any cause | Trial comparisons |
Colorectal Cancer and Non-Colorectal Cancer Cohort vs Breast Cancer and Ovarian Cancer Cohort: Number of Participants With Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE) v3.0 and v4.0 | Trial comparisons |
| Colorectal Cancer vs Non-Colorectal Cancer Cohort vs Breast and Ovarian Cohorts: serious adverse events | Trial comparisons |
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.
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GET https://conductscience.org/api/trials/v1/NCT00088413/results?page=2