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A Pilot Trial of GI-4000 Plus Bevacizumab and Either FOLFOX or FOLFIRI

NCT01322815 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2016-08-15

Study results available
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Summary

The purpose of this study is to test the safety of GI-4000 and see what effects (good and bad) it has against cancer over time. This study is also being done to measure the immune response to GI-4000. Study drug will be given in addition to a standard of care which is a standard therapy given to patients with your type of cancer (colon).

Conditions

Interventions

DRUG

chemotherapy and GI-4000

Standard chemotherapy and bevacizumab 40YU GI-4000 prior to initiation of chemotherapy and then intercycle 7 days after each chemotherapy cycle for up to 8 cycles. maintenance of GI-4000 injection and bevacizumab every 2 weeks

DRUG

GI-4000

40 YU GI-4000 every 2 weeks Bevacizumab every 2 weeks

Sponsors & Collaborators

  • GlobeImmune

    collaborator INDUSTRY

  • Georgetown University

    lead OTHER

Principal Investigators

  • John L Marshall, MD · Georgetown University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-10-31
Primary Completion
2014-09-30
Completion
2015-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT01322815 on ClinicalTrials.gov