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

• Status: Terminated
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Georgetown University
• Collaborator: GlobeImmune
• Treatments: Bevacizumab; Fluorouracil; Irinotecan; Leucovorin; Levoleucovorin; Oxaliplatin

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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