Trial · NCT01595321
Pancreatic Tumor Cell Vaccine (GVAX), Cyclophosphamide, SBRT, and FOLFIRINOX in Patients With Resected Adenocarcinoma of the Pancreas
NCT01595321, Phase 2, Completed, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins; results first posted 2024-08-14
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Pancreatic Tumor Cell Vaccine (GVAX), Cyclophosphamide, SBRT, and FOLFIRINOX in Patients With Resected Adenocarcinoma of the Pancreas. Trials, record NCT01595321. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01595321
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pancreatic Tumor Cell Vaccine (GVAX), Cyclophosphamide, SBRT, and FOLFIRINOX in Patients With Resected Adenocarcinoma of the Pancreas
- NCT number
- NCT01595321
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 19 participants, actual
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Conditions
- Pancreatic Cancer
- Interventions
- Cyclophosphamide, GVAX Pancreas Vaccine, Stereotactic Body Radiation, FOLFIRINOX
- First posted
- 2012-05-10
- Last updated
- 2024-08-14
- Results first posted
- 2024-08-14
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Dose Limiting Toxicities | 8 weeks | The number of participants experiencing grade 3-4 diarrhea, neutropenia, and thrombocytopenia within the first 2 cycles (8 weeks) of treatment, regardless of attribution. The rates of each of these toxicities were considered unacceptable if they were 40%, 60%, and 40%, respectively. A decision rule similar to the traditional 3+3 design was used to determine whether it was safe to continue on to the next cohort. |
| Primary | Grade 3 or Higher Cy/GVAX-related Adverse Events | 116 months | Number of participants with grade 3 or above adverse event attributed to Cy or the GVAX pancreas vaccine. Each adverse event (as defined by NCI CTCAE v4.0) was counted only once for a given subject. |
| Secondary | Overall Survival (OS) | 96 months | OS was measured as the amount of time from date of surgery until death or end of follow-up. OS was censored on the date the subject was last known to be alive for subjects without documentation of death at the time of analysis. Estimation based on the Kaplan-Meier curve. |
| Secondary | Disease-free Survival (DFS) | 96 months | DFS was measured as the time from date of surgery until pancreatic cancer recurrence or death. Disease status was monitored by radiologic scans done approximately every 12 weeks. DFS was censored on the date of last radiologic scan for subjects without documentation of cancer recurrence or death at the time of analysis. Estimation based on the Kaplan-Meier curve. |
| Secondary | Distant Metastases Free Survival (DMFS) | 96 months | DMFS was measured as the amount of time from date of surgery until metastatic disease progression or death. Metastatic disease progression is the appearance of one or more new lesions outside the primary tumor area (pancreas). Disease status was monitored by radiologic scans done approximately every 12 weeks. DMFS was censored on the date of last radiographic scans for subjects without documentation of metastatic disease progression or death at the time of analysis. Estimation based on the Kaplan-Meier curve. |
| Secondary | Freedom From Local Progression (FFLP) | 96 months | FFLP was measured as the time from date of surgery until disease recurrence in the pancreas or death. Disease status was monitored by radiologic scans done approximately every 12 weeks. FFLP was censored on the date of last radiographic scans for subjects without documentation of local disease recurrence or death at the time of analysis. Estimation based on the Kaplan-Meier curve. |
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 | Dose Limiting Toxicities | 8 weeks | One patient in cohort 2 was not evaluable because they did not complete 2 cycles of FOLFIRINOX. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Grade 3 or Higher Cy/GVAX-related Adverse Events | 116 months | Only Cohort 3 received Cy and GVAX and could be evaluated for this outcome. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Overall Survival (OS) | 96 months | months | MEDIAN | |
| SECONDARY | Disease-free Survival (DFS) | 96 months | months | MEDIAN | |
| SECONDARY | Distant Metastases Free Survival (DMFS) | 96 months | months | MEDIAN | |
| SECONDARY | Freedom From Local Progression (FFLP) | 96 months | months | MEDIAN |
Source ClinicalTrials.gov
Results by group22
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Dose Limiting Toxicities | Cohort 1: SBRT and FOLFIRINOX | Diarrhea | 0 | Participants | |
| Dose Limiting Toxicities | Cohort 2: SBRT and Modified FOLFIRINOX | Diarrhea | 0 | Participants | |
| Dose Limiting Toxicities | Cohort 3: CY, GVAX, SBRT, and Modified FOLFIRINOX | Diarrhea | 1 | Participants | |
| Dose Limiting Toxicities | Cohort 1: SBRT and FOLFIRINOX | Neutropenia | 3 | Participants | |
| Dose Limiting Toxicities | Cohort 2: SBRT and Modified FOLFIRINOX | Neutropenia | 0 | Participants | |
| Dose Limiting Toxicities | Cohort 3: CY, GVAX, SBRT, and Modified FOLFIRINOX | Neutropenia | 1 | Participants | |
| Dose Limiting Toxicities | Cohort 1: SBRT and FOLFIRINOX | Thrombocytopenia | 2 | Participants | |
| Dose Limiting Toxicities | Cohort 2: SBRT and Modified FOLFIRINOX | Thrombocytopenia | 0 | Participants | |
| Dose Limiting Toxicities | Cohort 3: CY, GVAX, SBRT, and Modified FOLFIRINOX | Thrombocytopenia | 0 | Participants | |
| Grade 3 or Higher Cy/GVAX-related Adverse Events | Cohort 3: CY, GVAX, SBRT, and Modified FOLFIRINOX | 2 | Participants |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort 1: SBRT and FOLFIRINOX | 3 | |
| Overall Study | STARTED | Cohort 2: SBRT and Modified FOLFIRINOX | 4 | |
| Overall Study | STARTED | Cohort 3: CY, GVAX, SBRT, and Modified FOLFIRINOX | 12 | |
| Overall Study | COMPLETED | Cohort 1: SBRT and FOLFIRINOX | 2 | |
| Overall Study | COMPLETED | Cohort 2: SBRT and Modified FOLFIRINOX | 3 | |
| Overall Study | COMPLETED | Cohort 3: CY, GVAX, SBRT, and Modified FOLFIRINOX | 7 | |
| Overall Study | NOT COMPLETED | Cohort 1: SBRT and FOLFIRINOX | 1 | |
| Overall Study | NOT COMPLETED | Cohort 2: SBRT and Modified FOLFIRINOX | 1 | |
| Overall Study | NOT COMPLETED | Cohort 3: CY, GVAX, SBRT, and Modified FOLFIRINOX | 5 |
Source ClinicalTrials.gov
Adverse events525
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 | Abdominal pain | Gastrointestinal disorders | Cohort 1: SBRT and FOLFIRINOX | 2 | 3 | 3 |
| other | Abdominal pain | Gastrointestinal disorders | Cohort 2: SBRT and Modified FOLFIRINOX | 3 | 4 | 5 |
| other | Abdominal pain | Gastrointestinal disorders | Cohort 3: CY, GVAX, SBRT, and Modified FOLFIRINOX | 8 | 12 | 9 |
| other | Agitation | Psychiatric disorders | Cohort 1: SBRT and FOLFIRINOX | 1 | 3 | 2 |
| other | Agitation | Psychiatric disorders | Cohort 2: SBRT and Modified FOLFIRINOX | 0 | 4 | 0 |
| other | Agitation | Psychiatric disorders | Cohort 3: CY, GVAX, SBRT, and Modified FOLFIRINOX | 2 | 12 | 2 |
| other | Alkaline phosphatase increased | Investigations | Cohort 1: SBRT and FOLFIRINOX | 0 | 3 | 0 |
| other | Alkaline phosphatase increased | Investigations | Cohort 2: SBRT and Modified FOLFIRINOX | 0 | 4 | 0 |
| other | Alkaline phosphatase increased | Investigations | Cohort 3: CY, GVAX, SBRT, and Modified FOLFIRINOX | 1 | 12 | 1 |
| other | Allergic rhinitis | Respiratory, thoracic and mediastinal disorders | Cohort 1: SBRT and FOLFIRINOX | 0 | 3 | 0 |
1 to 10 of 525Source ClinicalTrials.gov
See all 525 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort 1: SBRT and FOLFIRINOX | 3 | 3 |
| Total, all-cause mortality | Cohort 2: SBRT and Modified FOLFIRINOX | 3 | 4 |
| Total, all-cause mortality | Cohort 3: CY, GVAX, SBRT, and Modified FOLFIRINOX | 8 | 12 |
| Total, other adverse events | Cohort 1: SBRT and FOLFIRINOX | 3 | 3 |
| Total, other adverse events | Cohort 2: SBRT and Modified FOLFIRINOX | 4 | 4 |
| Total, other adverse events | Cohort 3: CY, GVAX, SBRT, and Modified FOLFIRINOX | 12 | 12 |
| Total, serious adverse events | Cohort 1: SBRT and FOLFIRINOX | 3 | 3 |
| Total, serious adverse events | Cohort 2: SBRT and Modified FOLFIRINOX | 1 | 4 |
| Total, serious adverse events | Cohort 3: CY, GVAX, SBRT, and Modified FOLFIRINOX | 6 | 12 |
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/NCT01595321
GET https://conductscience.org/api/trials/v1/NCT01595321/results?page=2