A Pilot Trial of GI-4000 Plus Bevacizumab and Either FOLFOX or FOLFIRI
Condition: Colon Cancer
MeSH terms: Colonic Neoplasms
Intervention: chemotherapy and GI-4000; GI-4000
Intervention description: 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; 40 YU GI-4000 every 2 weeks Bevacizumab every 2 weeks
Intervention MeSH terms: Leucovorin; Fluorouracil; Oxaliplatin; Irinotecan; Bevacizumab; Levoleucovorin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 11.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: colon cancer; metastatic; vaccine

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).
    

Eligibility 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