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

Phase 2TerminatedNCT01322815

Georgetown University11 enrolled

Overview

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).

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 40 yeast units (YU) 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 yeast unit (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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Colon Cancer

Interventions

chemotherapy and GI-4000DRUG

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

GI-4000DRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Georgetown University

Washington D.C., District of Columbia, United States

Outcomes

Primary Outcomes

Number of Participants Alive and Free of Progression at 4 Months (Patients Who Have Undergone Prior Therapy) and 10 Months (Untreated Patients)

Clinical benefit rate is defined as the proportion of patients alive and free of progression at 4 Months (Patients Who Have Undergone Prior Therapy) and 10 Months (Untreated Patients), assessed from first treatment with GI-4000. Progression is defined as CR (complete response) = disappearance of all target lesions; PR (partial response) = 30% decrease in the sum of the longest diameter of the target lesions; PD (progressive disease) = 20% increase in the sum of the longest diameter of the target lesions; or SD (stable disease) = small changes that do not meet the above criteria.

Time frame: 4 Months for patients who had undergone prior 1st-line therapy, and 10 months for previously untreated patients

Data from ClinicalTrials.gov

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