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Cancer Vaccine Targeting Brachyury Protein in Tumors

NCT01519817 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2018-01-29

Study results available
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Summary

Background:

\- Cancer vaccines are being developed to help teach the body's immune system to attack and destroy cancer cells. A new vaccine being tested targets Brachyury protein. This protein is present in some tumor cells, and it can help tumor cells spread to other parts of the body. Researchers want to see whether the new Brachyury protein vaccine can help treat people with advanced carcinomas.

Objectives:

\- To test the safety and effectiveness of a cancer vaccine that targets Brachyury protein in tumor cells.

Eligibility:

* Individuals at least 18 years of age who have advanced cancers that have not responded or are no longer responding to standard treatments.
* Because the vaccine is made with yeast, people with yeast allergies will not be eligible.

Design:

* Participants will be screened with a medical history and physical exam. Imaging studies will be used to examine the cancer. Heart and thyroid function tests will be conducted. Blood and urine samples will also be collected.
* Participants will receive vaccine injections every 2 weeks, for a total of seven visits. After seven visits, if the cancer has shrunk or stopped growing, participants will continue to have the vaccine about once a month.
* Treatment will be monitored with frequent blood tests and imaging studies. Other tests will be given as directed by the study doctors. Some participants will have apheresis to collect additional blood cells for study.
* Participants will continue to receive the vaccine as long the tumor does not start growing again and there are no serious side effects....

Conditions

  • Neoplasms
  • Malignant Solid Tumors
  • Colon Neoplasms
  • Adenocarcinoma

Interventions

BIOLOGICAL

GI-6301 (Yeast Brachyury Vaccine)

GI-6301 is a heat-killed, recombinant yeast-based vaccine engineered to express the transcription factor, Brachyury. The Brachyury gene is used to transfect the parental yeast strain (S. cerevisiae W303 - a haploid strain with known mutations from wildtype yeast) to produce the final recombinant vaccine product.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • James L Gulley, M.D. · National Cancer Institute (NCI)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-05
Primary Completion
2016-03-03
Completion
2016-09-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01519817 on ClinicalTrials.gov