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A Phase I Study of an MVA Vaccine Targeting P53 in Cancer

Phase 1
18 Years
Open (Enrolling)
Recurrent Colon Cancer, Recurrent Gastric Cancer, Recurrent Pancreatic Cancer, Recurrent Rectal Cancer, Stage III Colon Cancer, Stage III Gastric Cancer, Stage III Pancreatic Cancer, Stage III Rectal Cancer, Stage IV Colon Cancer, Stage IV Gastric Cancer, Stage IV Pancreatic Cancer, Stage IV Rectal Cancer

Thank you

Trial Information

A Phase I Study of an MVA Vaccine Targeting P53 in Cancer

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.

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

- 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

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety as assessed by CTCAE V.4 toxicity scale

Outcome Description:

Safety data for each administered dose will be summarized using descriptive numbers and 95% confidence intervals from the exact binomial distributions

Outcome Time Frame:

1 week after the third dose of vaccine

Safety Issue:


Principal Investigator

Vincent Chung, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

City of Hope Medical Center


United States: Institutional Review Board

Study ID:




Start Date:

October 2011

Completion Date:

Related Keywords:

  • Recurrent Colon Cancer
  • Recurrent Gastric Cancer
  • Recurrent Pancreatic Cancer
  • Recurrent Rectal Cancer
  • Stage III Colon Cancer
  • Stage III Gastric Cancer
  • Stage III Pancreatic Cancer
  • Stage III Rectal Cancer
  • Stage IV Colon Cancer
  • Stage IV Gastric Cancer
  • Stage IV Pancreatic Cancer
  • Stage IV Rectal Cancer
  • Colonic Neoplasms
  • Rectal Neoplasms
  • Stomach Neoplasms
  • Pancreatic Neoplasms



City of Hope Medical Center Duarte, California  91010