Can a Cancer-Fighting virus shrink tumors when chemo fails?
NCT ID NCT01394939
First seen Aug 05, 2026 · Last updated Aug 06, 2026 · Updated 1 time
Summary
This trial tests an experimental virus-based therapy called JX-594 (Pexa-Vec) in people with advanced colorectal cancer that has not responded to standard treatments. The virus is designed to infect and kill cancer cells while also stimulating the immune system. It is given alone or combined with the chemotherapy drug irinotecan. The study aims to see if this approach can shrink tumors and help patients live longer.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- JX-594 (Pexa-Vec), a modified vaccinia virus, given alone or with the chemotherapy drug irinotecan
- What this could lead to
- If successful, this could offer a new treatment option for people with advanced colorectal cancer who have run out of standard therapies, potentially slowing tumor growth and extending survival.
- What could go wrong
- This is an early-phase trial, so the treatment may not work or may cause significant side effects. The virus-based approach is experimental, and results may not apply to all patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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52 people
The number who actually took part.
- Start date
-
Jan 2012
- Finished
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Oct 2015
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Histologically-confirmed, advanced metastatic colorectal cancer failed treatment with fluoropyrimidine (fluoruracil or capecitabine) and oxaliplatin based therapies or had contradictions to treatment with these drugs as determined by the investigator * Failed treatment with irinotecan * Kras mutant tumor or Kras wild-type having failed cetuximab (Erbitux) or panitumumab (Vectibix) or had contradictions to treatment * Regorafenib-naïve (have not received regorafenib) * Eastern Cooperative Oncology Group (ECOG) Performance Status 0, 1 or 2 * Measurable tumor (≥1 cm longest diameter) * Acceptable health status as determined by the investigator and blood work (Chemistry, Complete Blood Count, Coagulation) Exclusion Criteria: * Intolerant to Irinotecan (if assigned to the combination arm: Cohort 3, Cohort 4 or Combination Expansion Arm) * Treatment with ketoconazole, enzyme-inducing anticonvulsants and St. John's Wort (if assigned to combination arm) * Significant immunodeficiency due to underlying illness and/or medication * History of severe exfoliative skin condition requiring systemic therapy within the past 2 years * Clinically significant and/or rapidly accumulating ascites, pericardial and/or pleural effusions * Active cardiovascular disease, including but not limited to significant coronary artery disease (e.g., requiring angioplasty or stenting) or congestive heart failure within the preceding 12 months * Viable Centrual Nervous System (CNS) malignancy associated with clinical symptoms * Received anti-cancer therapy within 4 weeks prior to first treatment (6 weeks for mitomycin c or nitrosoureas) * Prior participation in any other research protocol involving an investigational medicinal product within 4 weeks prior to first treatment * Use of prohibited anti-viral medication, interferon/pegylated interferon (PEG-IFN) or ribavirin that cannot be discontinued within 14 days prior to any JX 594 dose * Inability to suspend treatment with anti-hypertensive medication for 48 hours prior to and 48 hours after all JX-594 treatments. * Pregnant or nursing an infant * Diagnosis of chronic inflammatory bowel disease and/or bowel obstruction.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Billings Clinic Cancer Center
Billings, Montana, 59101, United States
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Gabrail Cancer Center
Canton, Ohio, 44718, United States
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Hôpital Hautepierre
Strasbourg, 67200, France
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Hôpital Saint Antoine
Paris, 75012, France
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Institut Claudius Regaud
Toulouse, 31052, France
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Juravinski Cancer Centre
Hamilton, Ontario, L8V 5C2, Canada
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Mayo Clinic
Scottsdale, Arizona, 85259-5499, United States
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Ottawa Hospital and Research Institute (OHRI)
Ottawa, Ontario, K1H 8L6, Canada
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The Ohio State University
Columbus, Ohio, 43210, United States
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UCSD Moores Cancer Center
La Jolla, California, 92093, United States
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University of North Carolina
Chapel Hill, North Carolina, 27599-1651, United States
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