Virus therapy takes on Drug-Resistant colorectal cancer
NCT ID NCT01380600
First seen Jul 08, 2026 · Last updated Jul 09, 2026 · Updated 1 time
Summary
This early-phase trial tests a modified virus 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. The main goal is to check the safety of giving this virus by intravenous infusion every two weeks, and to find the highest dose that can be given safely.
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 (a modified vaccinia virus with GM-CSF)
- What this could lead to
- If it works, this could point toward a new treatment option for advanced colorectal cancer that has stopped responding to standard therapies.
- What could go wrong
- This is an early-phase safety study with only 15 participants, so it is too small to prove effectiveness. The virus therapy may cause serious side effects, including flu-like symptoms and other toxicities.
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
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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15 people
The number who actually took part.
- Start date
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Sep 2010
- Finished
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Oct 2012
- Lead sponsor
-
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
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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 carcinoma * Failed both oxaliplatin and irinotecan based regimens for advanced/metastatic disease (if tumor advanced either immediately or within 3 months of the end of treatment) * Resistance to Erbitux: patients with Ras mutations, or for whom Erbitux has failed (if tumor advanced either immediately or within 3 months of the end of treatment, or there is no response to Erbitux therapy due to a lack of expression of EGFR (epidermal growth factor)) * Karnofsky Performance Score (KPS) ≥ 70 * Age ≥18 years * Laboratory Safety: WBC ≥ 3,500 cells/mm3 and ≤ 50,000 cells/mm3, ANC ≥ 1,500 cells/mm3, Hemoglobin ≥ 10 g/dL (transfusion allowed), Platelet count ≥ 100,000 plts/mm3,Total bilirubin ≤ 1.5 X ULN, INR ≤ 1.5, AST, ALT ≤ 2.5x ULN (in case of liver metastasis: AST,ALT ≤5.0 x ULN) * Serum chemistries within normal limits (WNL) or Grade 1 (excluding alkaline phosphatase) - If patients are diabetic, a fasting glucose must be done and patients must be \> 160 mg/dL. * Patients who, if they are sexually active, are willing and able to refrain from sexual activity for 3 weeks following JX-594 administration. Patients who are willing and able to use a permitted contraceptive for 3 months after the final administration of JX-594. Exclusion Criteria: * Significant immunodeficiency due to underlying illness (e.g. HIV/AIDS) and/or medication (e.g. systemic corticosteroids) * Known myeloproliferative disorders requiring systemic therapy * History of exfoliative skin condition (e.g. eczema or ectopic dermatitis) requiring systemic therapy * History of acquiring opportunistic infections. * Tumor(s) invading a major vascular structure (e.g. carotid artery) * Tumor(s) in location that would potentially result in significant clinical adverse effects if post-treatment tumor swelling were to occur * Clinically uncontrolled and/or rapidly accumulating ascites, pericardial and/or pleural effusions * History of severe or unstable cardiac disease * Current, known CNS malignancy (history of completely resected or irradiated brain metastases by WBRT or stereotactic radiosurgery allowed) * Administered anti-cancer therapy within 4 weeks prior to first treatment (6 weeks in case of mitomycin C or nitrosoureas) * Use of anti-viral, anti-platelet, or anti-coagulation medication \[Patients who discontinue such medications within 7 days prior to first treatment may be eligible for this study.\] Low dose aspirin (approximately 81 mg) allowed. * Pulse oximetry O2 saturation \<90% Pulse oximetry O2 saturation \<90% at rest * Experienced a severe systemic reaction or side-effect as a result of a previous smallpox vaccination * Pregnant or nursing * Household contact exclusions: * Women who are pregnant or nursing an infant * Children \< 5 years old * People with skin disease (e.g. eczema, atopic dermatitis, and related diseases * Immunocompromised hosts (severe deficiencies in cell-mediated immunity, including AIDS, organ transplant recipients, hematologic malignancies)
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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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Samsung Medical Center
Seoul, South Korea
More trials for these conditions
Other studies related to the condition(s) this trial covers.