Virus therapy takes on Drug-Resistant colorectal cancer

NCT ID NCT01380600

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

15 people

The number who actually took part.

Start date

Sep 2010

Finished

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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

  • Samsung Medical Center

    Seoul, South Korea

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