Vaccine Therapy in Treating Patients With Colorectal, Stomach, or Pancreatic Cancer

NCT01191684 | Completed Phase 1 DMC

• 2 other identifiers: 10105NCI-2010-01859
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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

  Assessed up to 12 months

Secondary Outcomes (1)

• Immunogenicity

  Assesse up to 12 months

Study Arms (1)

Treatment (vaccine therapy)

EXPERIMENTAL

Patients receive MVAp53 subcutaneously on days 0, 21, and 42 in the absence of unacceptable toxicity.

Other: laboratory biomarker analysis; Other: enzyme-linked immunosorbent assay; Other: flow cytometry; Other: immunoenzyme technique; Biological: modified vaccinia virus ankara vaccine expressing p53

Interventions

laboratory biomarker analysis OTHER

Correlative studies

Treatment (vaccine therapy)

enzyme-linked immunosorbent assay OTHER

Correlative studies

Also known as: ELISA

Treatment (vaccine therapy)

flow cytometry OTHER

Correlative studies

Treatment (vaccine therapy)

immunoenzyme technique OTHER

Correlative studies

Also known as: immunoenzyme techniques

Treatment (vaccine therapy)

modified vaccinia virus ankara vaccine expressing p53 BIOLOGICAL

Given SC

Also known as: MVA-p53 vaccine, MVAp53 vaccine

Treatment (vaccine therapy)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• City of Hope Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

City of Hope Medical Center

Duarte, California, 91010, United States

Location

Related Publications (1)

• 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.

  PMID: 24987057 RESULT

MeSH Terms

Conditions

Colonic Neoplasms; Stomach Neoplasms; Pancreatic Neoplasms; Rectal Neoplasms

Interventions

Enzyme-Linked Immunosorbent Assay; Flow Cytometry; Immunoenzyme Techniques; MVAp53 vaccine

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Stomach Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Immunoassay; Immunologic Techniques; Investigative Techniques; Immunosorbent Techniques; Immunohistochemistry; Molecular Probe Techniques; Cell Separation; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Cytophotometry; Fluorometry; Luminescent Measurements; Photometry; Chemistry Techniques, Analytical

Study Officials

• Vincent Chung, MD

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2010
• First Posted: August 31, 2010
• Study Start: October 1, 2011
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: August 1, 2017

Record last verified: 2017-07

Locations

US (1)