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

NCT ID: NCT01322815

Last Updated: 2016-08-15

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-10-31
• Study Completion Date: 2015-12-31

Brief 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).

Detailed Description

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

Conditions

Colon Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Chemotherapy and GI-4000

Standard chemotherapy and bevacizumab 40 yeast units (YU) 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

Group Type: EXPERIMENTAL

chemotherapy and GI-4000

Intervention Type: DRUG

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-4000 and bevacizumab

maintenance with GI-4000 and bevacizumab for patients who have completed first-line chemotherapy

Group Type: EXPERIMENTAL

GI-4000

Intervention Type: DRUG

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

Interventions

chemotherapy and GI-4000

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

Intervention Type: DRUG

GI-4000

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

Intervention Type: DRUG

Other Intervention Names

5-fluorouracil (5-FU), leucovorin. oxaliplatin; 5-fluorouracil (5-FU), leucovorin, irinotecan; avastin; Avastin

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

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlobeImmune

INDUSTRY

Sponsor Role: collaborator

Georgetown University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John L Marshall, MD

Role: PRINCIPAL_INVESTIGATOR

Georgetown University

Locations

Georgetown University

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

Countries

United States

Other Identifiers

GI-4000-05

Identifier Type: -

Identifier Source: org_study_id