Trial · NCT01329809
Neoadjuvant Recombinant Vaccinia Virus for Metastatic Colorectal Cancer With Liver Resection
NCT01329809, Phase 2, Terminated, Jennerex Biotherapeutics
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Neoadjuvant Recombinant Vaccinia Virus for Metastatic Colorectal Cancer With Liver Resection. Trials, record NCT01329809. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01329809
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Neoadjuvant Recombinant Vaccinia Virus for Metastatic Colorectal Cancer With Liver Resection
- NCT number
- NCT01329809
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 2 participants, actual
- Lead sponsor
- Jennerex Biotherapeutics
- Conditions
- Colorectal Carcinoma
- Interventions
- Recombinant Vaccinia GM-CSF; RAC VAC GM-CSF (JX-594)
- First posted
- 2011-04-06
- Last updated
- 2026-10-02
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Delivery to and Replication Within Tumors | Day 1, 3, 5, 8, 11, and 15 | IT injection: replication and dissemination of JX-594 following injection of a single colorectal metastasis within the liver. A positive replication response is defined as a \> 2-fold increase in viral genome concentration in the blood(as measured in the first 12 hours following injection) within the first 14 days following treatment. Note: Viral genomes will be measured in the blood by Q-PCR at baseline, on Day 1 (15 minutes, 3 hours \& 8 hours) post-treatment and on Days 3, 5, 8, 11 and 15. IV infusion: assessment of viral gene \& protein expression in histologic samples of tumor tissue |
| Secondary | JX-594 Spread to, and Replication Within, Non-injected Tumors After IT JX-594 Injection | Day 1 | JX-594 spread to, and replication within, non-injected tumors after IT JX-594 injection as measured by the presence of viral protein expression and/or LacZ expression in non-injected tumor sections from at least 1) two different non-consecutive cuts, both of which contain viable tumor tissue in at least 10 high power fields; and 2) at least 5 cells in one high power field show positive staining for viral protein and/ or LacZ expression |
| Secondary | Modified Choi Response Assessment | Day 8-14 | Modified Choi response assessment based on DCE-MRI at baseline and between Days 8 14 (within 7 days prior to surgical resection) |
| Secondary | Toxicity: Grade I-IV Adverse Events (According to CTCAE) | Day 1- Day 43 | Toxicity: Grade I-IV Adverse Events (according to CTCAE); including surgical complications such as delay of surgery, prolonged hospitalization, bleeding (monitor transfusion requirements), postoperative infections, bile leak, hepatic failure sepsis and death |
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/NCT01329809
GET https://conductscience.org/api/trials/v1/NCT01329809/registered