Recurrent Colon CancerPhase 1NCT01191684
Vaccine Therapy in Treating Patients With Colorectal, Stomach, or Pancreatic Cancer
A Phase 1 study testing laboratory biomarker analysis, enzyme-linked immunosorbent assay and flow cytometry in people with Recurrent Colon Cancer and Recurrent Gastric Cancer, run by City of Hope Medical Center at 1 site in United States.
Trial summary
RATIONALE: Vaccines made from a gene-modified virus may help the body build an effective immune response to kill tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of vaccine therapy in treating patients with colorectal, stomach, or pancreatic cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent Colon Cancer, Recurrent Gastric Cancer, Recurrent Pancreatic Cancer
- What is being tested?
- laboratory biomarker analysis, enzyme-linked immunosorbent assay and flow cytometry
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Dec 2011to 19 Aug 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
City of Hope Medical Center
Duarte, California, 91010
About this study
Official title: A Phase I Study of an MVA Vaccine Targeting P53 in Cancer
RATIONALE: Vaccines made from a gene-modified virus may help the body build an effective immune response to kill tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of vaccine therapy in treating patients with colorectal, stomach, or pancreatic cancer.
Read the detailed description
PRIMARY OBJECTIVES:I. To establish whether 2 vaccine dose levels of modified vaccinia virus ankara vaccine expressing p53 (MVAp53) vaccines are safe and well tolerated in patients with p53 over-expressing solid tumor malignancy.
SECONDARY OBJECTIVES:I. To provide preliminary evidence of enhanced cellular and humoral immunity to p53.
OUTLINE:This is a phase I, dose-escalation trial of modified vaccinia virus ankara vaccine expressing p53 (MVAp53).Patients receive MVAp53 subcutaneously (SC) on days 0, 21, and 42 in the absence of unacceptable toxicity.
After completion of study treatment, patients are followed up annually for 5 years.
- Conditions
- Recurrent Colon Cancer, Recurrent Gastric Cancer, Recurrent Pancreatic Cancer, Recurrent Rectal Cancer, Stage III Colon Cancer, Stage III Gastric Cancer
- Being tested
- laboratory biomarker analysis, enzyme-linked immunosorbent assay, flow cytometry, immunoenzyme technique, modified vaccinia virus ankara vaccine expressing p53
- Medical subject headings
- Colonic Neoplasms, Stomach Neoplasms, Pancreatic Neoplasms, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laboratory biomarker analysisOther
Correlative studies
enzyme-linked immunosorbent assayOther
Also called ELISA
Correlative studies
flow cytometryOther
Correlative studies
immunoenzyme techniqueOther
Also called immunoenzyme techniques
Correlative studies
modified vaccinia virus ankara vaccine expressing p53Biological
Also called MVA-p53 vaccine, MVAp53 vaccine
Given SC
| Study group | Role | What they receive |
|---|---|---|
| Treatment (vaccine therapy) | Experimental | Patients receive MVAp53 subcutaneously on days 0, 21, and 42 in the absence of unacceptable toxicity. Receives: Other: laboratory biomarker analysis; Other: enzyme-linked immunosorbent assay; Other: flow cytometry; Other: immunoenzyme technique; Biological: modified vaccinia virus ankara vaccine expressing p53 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerance of modified vaccinia virus ankara vaccine expressing p53 assessed by the Common Terminology Criteria for Adverse Events (CTCAE) version 4 toxicity scale
Safety data for each administered dose will be summarized using descriptive numbers and 95% confidence intervals from the exact binomial distributions
Measured: Assessed up to 12 months
Secondary outcomes (1)
Immunogenicity
Assessed using enzyme-linked immunosorbent assay (ELISA) for humoral response, lymphoproliferation for cluster of differentiation (CD)4+ T cell response, and intracytoplasmic cytokine assays, and interferon (IFN)-gamma and interleukin (IL)-4 by enzyme-linked immunosorbent spot (ELISPOT) for the assessment of cellular immune response. For each assay, the pre-vaccine values will be compared to the highest post-vaccine values. Immunogenicity changes and the maximum change will be quantified by mean, standard deviation, median, and range and tested by paired t-test at the 0.05 significance level.
Measured: Assesse up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2010 (estimated)
- Study start22 Dec 2011
- Primary completion19 Aug 2013
- Study completion19 Aug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Recurrent Colon CancerStudies of the same condition, open and under way.
- More trials run by City of Hope Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Vincent Chung, MD, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01191684
- Sponsor's protocol ID
- 10105
- Other IDs
- NCI-2010-01859
- Status last verified
- Oct 2026
- First submitted
- 27 Aug 2010
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hardwick NR, Carroll M, Kaltcheva T, Qian D, Lim D, Leong L, Chu P, Kim J, Chao J, Fakih M, Yen Y, Espenschied J, Ellenhorn JD, Diamond DJ, Chung V. p53MVA therapy in patients with refractory gastrointestinal malignancies elevates p53-specific CD8+ T-cell responses. Clin Cancer Res. 2014 Sep 1;20(17):4459-70. doi: 10.1158/1078-0432.CCR-13-3361. Epub 2014 Jul 1.
PubMed 24987057
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of an MVA Vaccine Targeting P53 in Cancer
- ClinicalTrials.gov ID
- NCT01191684
- Acronym / sponsor ID
- 10105
- Conditions
- Recurrent Colon Cancer, Recurrent Gastric Cancer, Recurrent Pancreatic Cancer, Recurrent Rectal Cancer, Stage III Colon Cancer, Stage III Gastric Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 22 Dec 2011 (actual)
- Primary completion
- 19 Aug 2013 (actual)
- Study completion
- 19 Aug 2013 (actual)
- First posted
- 31 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Vaccines made from a gene-modified virus may help the body build an effective immune response to kill tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of vaccine therapy in treating patients with colorectal, stomach, or pancreatic cancer.
Detailed description
PRIMARY OBJECTIVES:I. To establish whether 2 vaccine dose levels of modified vaccinia virus ankara vaccine expressing p53 (MVAp53) vaccines are safe and well tolerated in patients with p53 over-expressing solid tumor malignancy.
SECONDARY OBJECTIVES:I. To provide preliminary evidence of enhanced cellular and humoral immunity to p53.
OUTLINE:This is a phase I, dose-escalation trial of modified vaccinia virus ankara vaccine expressing p53 (MVAp53).Patients receive MVAp53 subcutaneously (SC) on days 0, 21, and 42 in the absence of unacceptable toxicity.
After completion of study treatment, patients are followed up annually for 5 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (vaccine therapy) | Experimental | Other: laboratory biomarker analysis, Other: enzyme-linked immunosorbent assay, Other: flow cytometry, Other: immunoenzyme technique, Biological: modified vaccinia virus ankara vaccine expressing p53Patients receive MVAp53 subcutaneously on days 0, 21, and 42 in the absence of unacceptable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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)
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| laboratory biomarker analysisCorrelative studies | Other | Treatment (vaccine therapy) |
| enzyme-linked immunosorbent assayAlso: ELISACorrelative studies | Other | Treatment (vaccine therapy) |
| flow cytometryCorrelative studies | Other | Treatment (vaccine therapy) |
| immunoenzyme techniqueAlso: immunoenzyme techniquesCorrelative studies | Other | Treatment (vaccine therapy) |
| modified vaccinia virus ankara vaccine expressing p53Also: MVA-p53 vaccine, MVAp53 vaccineGiven SC | Biological | Treatment (vaccine therapy) |
Primary outcome
Safety and tolerance of modified vaccinia virus ankara vaccine expressing p53 assessed by the Common Terminology Criteria for Adverse Events (CTCAE) version 4 toxicity scale
Time frame: Assessed up to 12 months
Safety data for each administered dose will be summarized using descriptive numbers and 95% confidence intervals from the exact binomial distributions
1 secondary outcome
Immunogenicity
Time frame: Assesse up to 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
- Results publication: PubMed 24987057Hardwick NR, Carroll M, Kaltcheva T, Qian D, Lim D, Leong L, Chu P, Kim J, Chao J, Fakih M, Yen Y, Espenschied J, Ellenhorn JD, Diamond DJ, Chung V. p53MVA therapy in patients with refractory gastrointestinal malignancies elevates p53-specific CD8+ T-cell responses. Clin Cancer Res. 2014 Sep 1;20(17):4459-70. doi: 10.1158/1078-0432.CCR-13-3361. Epub 2014 Jul 1.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vincent Chung, MD principal investigator
City of Hope Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing laboratory biomarker analysis, enzyme-linked immunosorbent assay and flow cytometry in people with Recurrent Colon Cancer and Recurrent Gastric Cancer, run by City of Hope Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerance of modified vaccinia virus ankara vaccine expressing p53 assessed by the Common Terminology Criteria for Adverse Events (CTCAE) version 4 toxicity scale (time frame: Assessed up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01191684, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026.