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

Primary Purpose

Colon Cancer

Status

Terminated

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

chemotherapy and GI-4000

GI-4000

About this trial

This is an interventional treatment trial for Colon Cancer focused on measuring colon cancer, metastatic, vaccine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Georgetown University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Chemotherapy and GI-4000

GI-4000 and bevacizumab

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT01322815

First Posted

March 23, 2011

Last Updated

July 6, 2016

Sponsor

Georgetown University

Collaborators

GlobeImmune

1. Study Identification

Unique Protocol Identification Number

NCT01322815

Brief Title

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

Official Title

A Pilot Trial of GI-4000 Plus Bevacizumab and Either FOLFOX or FOLFIRI in Patients With Ras Mutant Positive Metastatic Colorectal Cancer, Either Newly Diagnosed or Previously Treated.

Study Type

Interventional

2. Study Status

Record Verification Date

February 2016

Overall Recruitment Status

Terminated

Why Stopped

Poor accrual rate

Study Start Date

October 2010 (undefined)

Primary Completion Date

September 2014 (Actual)

Study Completion Date

December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Georgetown University

Collaborators

GlobeImmune

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Colon Cancer

Keywords

colon cancer, metastatic, vaccine

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

11 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Chemotherapy and GI-4000

Arm Type

Experimental

Arm Description

Arm Title

GI-4000 and bevacizumab

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

chemotherapy and GI-4000

Other Intervention Name(s)

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

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

Intervention Type

Drug

Intervention Name(s)

GI-4000

Other Intervention Name(s)

Avastin

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

John L Marshall, MD

Organizational Affiliation

Georgetown University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Georgetown University

City

Washington

State/Province

District of Columbia

ZIP/Postal Code

20007

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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