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

Stopped early · Phase 2

Conditions studied: Colon Cancer

In brief

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).

Key facts

Study ID

NCT01322815

Run by

Georgetown University

People needed

11

Starts

2010-10-01

Expected to finish

2015-12-01

Last updated by the study team

2016-08-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically or cytologically confirmed diagnosis of metastatic colorectal cancer with a Ras mutation
• Measurable or evaluable disease
• No prior therapy fore metastatic disease except for group A: > 6 months since completion of adjuvant therapy and Group B: those patients who enroll just after completing bevacizumab plus FOLFOX or FOLFIRI
• Anticipated survival of at least 6 months
• Ambulatory with Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Ability to maintain weight
• Normal organ and marrow function
• Women of child-bearing potential and men must agree to avoid pregnancy or fathering a child for the duration of study participation and for 6 months after the final scheduled study visit.
• Ability to understand and willingness to sign a written informed consent document

You may not qualify if…

• Prior chemotherapy other than that listed in inclusion criteria
• Receiving any other investigational agent
• Known brain metastases, uncontrolled seizure disorders, encephalitis, or multiple sclerosis
• History of known hypersensitivity to S. cerevisiae, bevacizumab or any component of FOLFOX or FOLFIRI
• Concurrent and chronic therapy with corticosteroids or any other immunosuppressive drugs
• Uncontrolled hypertension, unstable angina, congestive heart failure, peripheral vascular disease, serious cardiac arrythmias requiring medication
• History of heart attack or stroke within 6 months before enrollment
• History of intra-abdominal abscess, abdominal fistula, gastrointestinal perforation, or active peptic ulcer disease
• Bleeding disorder or coagulopathy
• Serious non-healing wound, ulcer or bone fracture
• Major surgical procedure, open biopsy, or traumatic injury within 4 weeks prior to enrollment or anticipation of need for surgery during the study
• Known active infection with HIV, hepatitis B or C
• History of splenectomy
• History of Crohn's disease or ulcerative colitis
• History of organ transplantation
• Evidence of immunodeficiency or immune suppression
• Any Autoimmune disease
• Active infection
• Concurrent malignancy
• Pregnant or nursing

Where it is running

• Georgetown University — Washington D.C., District of Columbia, United States

Full record on ClinicalTrials.gov

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