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

A Pilot Study of Active Immunotherapy With CEA(6D) VRP Vaccine (AVX701) in Patients With Stage III Colorectal Cancer

NCT01890213•Duke University

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Histologically confirmed stage III colorectal cancer as determined by AJCC 7th edition.
•Subjects must have received adjuvant post-operative chemotherapy meeting the following requirements:
•1. 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.
•2. 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:
•1. Neoadjuvant chemotherapy, if utilized, must have consisted of a 5-fluorouracil-based regimen (or capecitabine) with radiation
•2. 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
•3. 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.
+5 more criteria

Exclusion Criteria

•Patients with active cytotoxic chemotherapy or radiation therapy should be excluded. There are no exclusions based on the number of prior chemotherapy, biologic, hormonal, or experimental regimens. There must be at least 3 months between any prior CEA-targeted immunotherapy and study treatment and at least 4 weeks between any other prior therapy and study treatment.
•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.
+1 more criteria

Locations (1)

Duke University Medical Center

Durham, North Carolina, United States

Key Dates

Start Date

November 1, 2013

Primary Completion Date

June 1, 2017

Completion Date

July 1, 2019

Last Updated

July 18, 2019

Enrollment

ESTIMATED participants

Conditions

Stage III Colon Cancer

Interventions

AVX701

BIOLOGICAL

Testing the Combination of Two Anti-cancer Drugs, DS-8201a and AZD6738, for The Treatment of Advanced Solid Tumors Expressing the HER2 Protein or Gene, The DASH Trial

NCT04704661

Advanced Breast CarcinomaAdvanced Colon Carcinoma+38 more

View study

ACTIVE_NOT_RECRUITINGPHASE2

Panitumumab, Regorafenib, or TAS-102, in Treating Patients With Metastatic and/or Unresectable RAS Wild-Type Colorectal Cancer

NCT03992456

Metastatic Colon AdenocarcinomaMetastatic Colorectal Carcinoma+28 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 18, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Testing the Combination of Two Anti-cancer Drugs, DS-8201a and AZD6738, for The Treatment of Advanced Solid Tumors Expressing the HER2 Protein or Gene, The DASH Trial

Panitumumab, Regorafenib, or TAS-102, in Treating Patients With Metastatic and/or Unresectable RAS Wild-Type Colorectal Cancer

TAS-102, Irinotecan, and Bevacizumab for the Treatment of Pre-treated Metastatic or Unresectable Colorectal Cancer, the TABAsCO Study

Exploiting Circulating Tumour DNA to Intensify the Postoperative Treatment Resected Colon Cancer Patients

Health Care Coach Support in Reducing Acute Care Use and Cost in Patients With Cancer

Exercise and Colon Cancer