Expired Study
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Washington, District of Columbia 20007


Purpose:

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).


Study summary:

Subject visits will occur 1-4 weeks prior to initiation of GI-4000, then - In newly diagnosed (Group A) patients, at every FOLFOX/FOLFIRI plus bevacizumab visit, bevacizumab and GI-4000 dosing visit, GI-4000 dosing visit and then quarterly after completion of therapy - In patients with stable disease who have completed a first line therapy with an oxaliplatin or irinotecan plus fluoropyrimidine and bevacizumab containing regimen (Group B), at every bevacizumab and GI-4000 dosing visit, GI-4000 dosing visit and then quarterly after completion of therapy Group A patients (N=26) will be enrolled into the study prior to the initiation of first line therapy with bevacizumab plus either FOLFOX (N=13) or FOLFIRI (N=13) - Subjects will receive 1 40YU dose of GI-4000 prior to initiation of FOLFOX or FOLFIRI plus bevacizumab, then intercycle doses of GI-4000 will be given 7 days after each cycle while first line therapy is given (up to 8 cycles) - After completion of first line therapy, subjects will enter the maintenance phase in which bevacizumab and GI-4000 will be given concurrently every 2 weeks for as long as therapy can be tolerated or until progression - If a subject discontinues bevacizumab therapy due to intolerance, the subject will continue GI-4000 every 2 weeks until progression, intolerance or withdrawal from the study Group B patients (N=26) with stable disease who have completed a first line therapy with an oxaliplatin or irinotecan plus fluoropyrimidine and bevacizumab containing regimen ) will enter the trial prior to receiving therapy with bevacizumab - Subjects will receive 40 YU GI-4000 concurrently with each bevacizumab dose for as long as therapy can be tolerated or until progression - If a subject discontinues bevacizumab therapy due to intolerance, the subject will continue GI-4000 every 2 weeks until progression, intolerance or withdrawal from the study


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 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


NCT ID:

NCT01322815


Primary Contact:

Principal Investigator
John L Marshall, MD
Georgetown University


Backup Contact:

N/A


Location Contact:

Washington, District of Columbia 20007
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: August 31, 2019

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