TerminatedNCT01322815Updated Aug 15, 2016Results posted

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

A Phase 2 interventional study of chemotherapy and GI-4000 and GI-4000 in Colon Cancer, sponsored by Georgetown University. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-08-15.

Sponsored by Georgetown University · Phase 2, Interventional, and Treatment

Why this study was terminated

Poor accrual rate

Phase: Phase 2
Study type: Interventional
Enrollment: 11
Allocation: Non-randomized
Ages: 18 Years and older
Sex: All

Study 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).

Read the 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 studied

Colon Cancer

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Keywords

colon cancer
metastatic
vaccine

In context

Colonic Neoplasms

1,485 studies on the registry are indexed under Colonic Neoplasms; 362 are open to participants now.

This study's enrollment of 11 is below the median of 89 across 1,067 interventional studies indexed under Colonic Neoplasms.

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Lead sponsor

Georgetown University is the lead sponsor of 291 studies on the registry; 41 are open to participants now.

Of its 28 completed or terminated interventional studies of FDA-regulated products, 20 (71%) have results posted.

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Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Non-randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 11 participants (actual)

Study arms

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

Interventions

Drugchemotherapy and GI-4000
Drug page: Bevacizumab
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
DrugGI-4000
40 YU GI-4000 every 2 weeks Bevacizumab every 2 weeks
Also known as: Avastin

What researchers measure

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

Results

Posted Aug 15, 2016

Participant flow

Participant flow — Overall Study
Milestone	Chemotherapy and GI-4000	GI-4000 and Bevacizumab
Started	7	4
Completed	7	4
Not completed	0	0

Outcome measures

PrimaryNumber 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
Reported as:: Number · participants

Number of Participants Alive and Free of Progression at 4 Months (Patients Who Have Undergone Prior Therapy) and 10 Months (Untreated Patients)
participants	Chemotherapy and GI-4000	GI-4000 and Bevacizumab
Number of Participants Alive and Free of Progression at 4 Months (Patients Who Have Undergone Prior Therapy) and 10 Months (Untreated Patients)	4	2

Adverse events

Collected over From 48 to 739 days: as long as each individual patient was on study (from Nov 2010 until Sep 2013). Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Chemotherapy and GI-4000	—	2/7 (28.6%)	7/7 (100%)
GI-4000 and Bevacizumab	—	0/4 (0%)	4/4 (100%)

Most frequent serious events

Most frequent serious events
Event	Chemotherapy and GI-4000	GI-4000 and Bevacizumab
thrombosisCardiac disorders	1/7	0/4
low neutrophil countBlood and lymphatic system disorders	1/7	0/4

Most frequent other events

Showing 10 of 12

Most frequent other events
Event	Chemotherapy and GI-4000	GI-4000 and Bevacizumab
Injection site reactionSkin and subcutaneous tissue disorders	1/7	3/4
diarrheaGastrointestinal disorders	4/7	0/4
EpitaxisRespiratory, thoracic and mediastinal disorders	4/7	1/4
FatigueGeneral disorders	4/7	1/4
Abdominal painGastrointestinal disorders	3/7	0/4
nauseaGastrointestinal disorders	3/7	1/4
rashSkin and subcutaneous tissue disorders	3/7	0/4
headacheNervous system disorders	1/7	1/4
VaginismusGeneral disorders	0/7	1/4
AlopeciaSkin and subcutaneous tissue disorders	1/7	0/4

Baseline characteristics

Patients with RAS mutant positive metastatic colorectal cancer (CRC), either having received prior 1st-line therapy with an oxaliplatin or irinotecan plus fluoropyrimidine and bevacizumab containing regimen, or no prior therapy.

Age, Categorical
Age, Categorical(Participants)	Chemotherapy and GI-4000	GI-4000 and Bevacizumab	Total
<=18 years	0	0	0
Between 18 and 65 years	5	4	9
>=65 years	2	0	2

Age, Continuous
Age, Continuous(years)	Chemotherapy and GI-4000	GI-4000 and Bevacizumab	Total
Median	48 (35 to 71)	45 (42 to 51)	45 (35 to 71)

Sex: Female, Male
Sex: Female, Male(Participants)	Chemotherapy and GI-4000	GI-4000 and Bevacizumab	Total
Female	2	3	5
Male	5	1	6

Region of Enrollment
Region of Enrollment(participants)	Chemotherapy and GI-4000	GI-4000 and Bevacizumab	Total
United States	7	4	11

Prior treatment status
Prior treatment status(participants)	Chemotherapy and GI-4000	GI-4000 and Bevacizumab	Total
Prior 1st-line therapy	0	4	4
No prior therapy	7	0	7

Study locations

1 site

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

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Timeline

Tracking since Sep 25, 2026

Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Oct 2010, a primary completion of Sep 2014 and a completion of Dec 2015. It does not say whether these dates are actual or estimated.

Results were first posted in Aug 2016, 1 year 11 months after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered: Mar 23, 2011
First posted: Mar 25, 2011
Start: Oct 2010
Primary completionActual: Sep 2014
CompletionActual: Dec 2015
Results first posted: Aug 15, 2016
Last update: Aug 15, 2016

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Aug 15, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01322815
Lead sponsor: Georgetown University
Collaborators: GlobeImmune
Responsible party: Sponsor
First posted: Mar 25, 2011
Start date: Oct 2010
Primary completion: Sep 2014
Completion: Dec 2015
Results posted: Aug 15, 2016
Last update: Aug 15, 2016

Study contacts

John L Marshall, MD

principal investigator · Georgetown University

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.

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Studies of the drugs tested here: Bevacizumab · GI-4000

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