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

NCT01322815 | Terminated Phase 2 Results DMC

• 1 other identifier: GI-4000-05
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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).

Conditions

Colon Cancer

Keywords

colon cancer; metastatic; vaccine

Outcome Measures

Primary Outcomes (1)

• 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.

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

Study Arms (2)

Chemotherapy and GI-4000

EXPERIMENTAL

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

Drug: chemotherapy and GI-4000

GI-4000 and bevacizumab

EXPERIMENTAL

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

Drug: GI-4000

Interventions

chemotherapy and GI-4000 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

Also known as: 5-fluorouracil (5-FU), leucovorin. oxaliplatin, 5-fluorouracil (5-FU), leucovorin, irinotecan, avastin

Chemotherapy and GI-4000

GI-4000 DRUG

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

Also known as: Avastin

GI-4000 and bevacizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Georgetown University: lead
• GlobeImmune: collaborator

Study Sites (1)

Georgetown University

Washington D.C., District of Columbia, 20007, United States

Location

MeSH Terms

Conditions

Colonic Neoplasms; Neoplasm Metastasis

Interventions

Drug Therapy; Fluorouracil; Leucovorin; Irinotecan; Bevacizumab

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes; Camptothecin; Alkaloids; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: John L Marshall
• Organization: Ruesch Center at Georgetown Lombardi

marshalj@georgetown.edu

202.444.7064

Study Officials

• John L Marshall, MD

  Georgetown University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2011
• First Posted: March 25, 2011
• Study Start: October 1, 2010
• Primary Completion: September 1, 2014
• Study Completion: December 1, 2015
• Last Updated: August 15, 2016
• Results First Posted: August 15, 2016

Record last verified: 2016-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)