Immunotherapy With CEA(6D) VRP Vaccine (AVX701) in Patients With Stage III Colorectal Cancer

NCT01890213 | Completed Phase 1

• 2 other identifiers: Pro00045976IND13372
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

This is a pilot study to evaluate the safety of a vaccine that consists of an alphavirus replicon (VRP) encoding the protein (CEA) that has been found to be associated with cancers such as colon cancer in patients that have stage III colon cancer. We will also evaluate the patient immune response to the vaccine.

Conditions

Stage III Colon Cancer

Keywords

alphavirus; colon cancer; immune response; CEA

Outcome Measures

Primary Outcomes (1)

• Number of participants with adverse events

  12 weeks

Study Arms (1)

Vaccine

EXPERIMENTAL

AVX701 Vaccine:4 x 10EE8 IU intramuscularly every 3 weeks for 4 total immunizations

Biological: AVX701

Interventions

AVX701 BIOLOGICAL

Also known as: VRP-CEA(6D)

Vaccine

Eligibility Criteria

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

You may qualify if:

• Histologically confirmed stage III colorectal cancer as determined by AJCC 7th edition.
• Subjects must have received adjuvant post-operative chemotherapy meeting the following requirements:
• Chemotherapy must have consisted of a 5-fluorouracil-based regimen with or without oxaliplatin for at least 6 cycles or capecitabine with or without oxaliplatin for 4 cycles.
• Chemotherapy must have been completed within 1-6 months of starting study treatment.
• Subjects with rectal cancer must have received chemotherapy meeting the following requirements:
• Neoadjuvant chemotherapy, if utilized, must have consisted of a 5-fluorouracil-based regimen (or capecitabine) with radiation
• Adjuvant chemotherapy must have consisted of a 5-fluorouracil-based regimen with or without oxaliplatin for at least 6 cycles or capecitabine with or without oxaliplatin for 4 cycles
• Chemotherapy must have been completed within 1-6 months of starting study treatment.
• Karnofsky performance status greater than or equal to 70%
• Estimated life expectancy \> 6 months and not expected to require further systemic chemotherapy for at least 3 months.
• Age ≥ 18 years
• Adequate hematologic function: WBC ≥ 3000/microliter, Hgb ≥ 9 g/dL (may transfuse or use erythropoietin to achieve this level), platelets ≥ 100,000/microliter
• Adequate renal and hepatic function, with serum creatinine \< 1.5 mg/dL, bilirubin \< 1.5 mg/dL (except for Gilbert's syndrome which will allow bilirubin ≤ 2.0 mg/dL), ALT and AST ≤ 2.5 x upper limit of normal.
• Ability to understand and provide signed informed consent that fulfills Institutional Review Board's guidelines.
• Ability to return to Duke University Medical Center for adequate follow-up, as required by this protocol

You may not qualify if:

• Evidence of metastatic disease.
• Patients with a history of autoimmune disease, such as but not restricted to, inflammatory bowel disease, systemic lupus erythematosus, ankylosing spondylitis, scleroderma, or multiple sclerosis.
• Patients with serious intercurrent chronic or acute illness, such as cardiac disease (NYHA class III or IV), hepatic disease, or other illness considered by the Principal Investigator as unwarranted high risk for investigational drug treatment.
• Patients with a medical or psychological impediment to probable compliance with the protocol should be excluded.
• Concurrent (or within the last 5 years) second malignancy other than non melanoma skin cancer, cervical carcinoma in situ, or controlled superficial bladder cancer.
• Presence of an active acute or chronic infection including: a urinary tract infection , HIV (as determined by ELISA and confirmed by Western Blot) or viral hepatitis (as determined by HBsAg and Hepatitis C serology). Patients with HIV are excluded based on immuno-suppression, which may render them unable to respond to the vaccine; patients with chronic hepatitis are excluded because of concern that hepatitis could be exacerbated by the injections.
• Patients on steroid therapy (or other immuno-suppressives, such as azathioprine or cyclosporin A) are excluded on the basis of potential immune suppression. Patients must have had 6 weeks of discontinuation of any steroid therapy (except that used as pre-medication for chemotherapy or contrast-enhanced studies) prior to enrollment.
• Patients with allergies to any component of the vaccine will be excluded from the protocol.
• Pregnant and nursing women should be excluded from the protocol since this research may have unknown and harmful effects on an unborn child or on young children. If the patient is sexually active, the patient must agree to use a medically acceptable form of birth control while receiving treatment and for a period of 4 months following the last vaccination therapy. It is not known whether the treatment used in this study could affect the sperm and could potentially harm a child that may be fathered while on this study.
• Patients with acute or chronic skin disorders that will interfere with injection into the skin of the extremities or subsequent assessment of potential skin reactions will be excluded.

Sponsors & Collaborators

• Duke University: lead
• AlphaVax, Inc.: collaborator

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Colonic Neoplasms

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

Study Officials

• Michael Morse, MD

  Duke University

  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: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 26, 2013
• First Posted: July 1, 2013
• Study Start: November 1, 2013
• Primary Completion: June 1, 2017
• Study Completion: July 1, 2019
• Last Updated: July 18, 2019

Record last verified: 2019-07

Locations

US (1)