Can a Virus-Based vaccine teach the immune system to hunt p53 in tumors?

NCT ID NCT01191684

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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 Results may not be published yet.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
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Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Oct 19, 2026 · Last updated Oct 20, 2026 · Updated 1 time

Summary

Researchers are testing a vaccine made from a modified vaccinia virus that carries the p53 protein, a target found in many tumors. The trial enrolls adults with advanced or recurrent colon, rectal, stomach, or pancreatic cancer that has not responded to chemotherapy. Participants receive the vaccine by injection, and the study measures side effects, finds the best dose, and checks whether the immune system mounts a response against p53.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
a modified vaccinia virus Ankara vaccine engineered to express the p53 protein
What this could lead to
If it works, this could point toward a vaccine that trains the immune system to attack p53-bearing tumors in several hard-to-treat digestive cancers.
What could go wrong
This is a very small phase I study, so its main job is to check safety and dosing, not to prove the vaccine shrinks tumors. Many experimental vaccines fail to trigger a strong enough immune response or help 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

Phase 1

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

Participants

12 people

The number who actually took part.

Started

Dec 2011

Finished

Aug 2013

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

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: * Patients with unresectable and chemotherapy resistant primary or recurrent carcinoma of colorectal, gastric or pancreatic origin * There must be pathologic evidence for malignancy with a soft tissue component of tumor evident on CT scan imaging or physical examination * Patient must be able to give informed consent * There must be an anticipated survival of at least 3 months * Performance status of 80-100 (Karnofsky performance status) * WBC count \>= 3,000uL * Platelet count \>= 100,000uL * Prothrombin time and partial thromboplastin time of \<= 1.5 times the upper limit of normal * Women of childbearing potential must have a negative pregnancy test; women and men of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for six months following duration of study participation; should a woman become pregnant during or suspect that she is pregnant while participating on the trial, she should inform her treating physician immediately * Patients with asymptomatic small volume bone disease not likely to require radiation therapy during the period of the vaccine trial will be eligible * Hemoglobin level \> 9g/dL * There must be evidence of p53 over expression by immunohistochemistry with \> 10% of cells within the tumor strongly positive * Patients with colorectal cancer will need to have failed to respond to 5-FU based therapy with oxaliplatin, irinotecan as well as epidermal growth factor receptor (EGFR) directed therapies (if appropriate); patients with gastric cancer will need to have progressed on standard first line chemotherapy or chemoradiotherapy and Herceptin based therapy (if appropriate); patients with pancreatic cancer who have failed to respond to at least 1 chemotherapy regimen Exclusion Criteria: * Diagnosis which has been associated with immunodeficiency, including HIV * Prior radiation to more than 50% of all nodal groups * Concurrent use of corticosteroids * History of another malignancy, other than nonmelanoma skin cancer in the past 2 years * Recent major surgery * Serious intercurrent illness * Temperature \>= 101F within 3 days prior to the initial injection * Pregnancy or lactation * Clinically evident brain metastasis * Autoimmune disease * HIV seropositivity or refusal to hear the results of the HIV test * Receipt of organ grafts * History of severe environmental allergies * History of severe neurological, cardiovascular, renal, hepatic, endocrine, respiratory, or bone marrow dysfunction requiring frequent re-evaluation, and management by a physician * Patients with a history of congestive heart failure or coronary artery disease which has not been resolved by bypass or stent * History of myopericarditis * Known family history of Li-Fraumeni syndrome * Allergy to egg proteins * Chemotherapy or radiation within the 4 weeks preceding enrollment

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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

  • City of Hope Medical Center

    Duarte, California, 91010, United States

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