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Monoclonal Antibodies

Riluzole + Chemotherapy for Colorectal Cancer

Phase 1
Waitlist Available
Led By Ning Jin, MD
Research Sponsored by Ning Jin
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 12 weeks after the last dose of study drug to minimize the risk of pregnancy. WOCBP must have a negative serum or urine pregnancy test within 72 hours before the start of the investigational product
Age >= 18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 of cycle 1,3,5,7 (each cycle is 14 days)
Awards & highlights

Study Summary

This trial is to find the best dose of riluzole to combine with standard chemotherapy (mFOLFOX6 and bevacizumab) for treating colorectal cancer that has spread to other places in the body. Riluzole may make chemotherapy work better. Bevacizumab is an antibody that targets the blood vessel by blocking the activity of a protein called vascular endothelial growth factor alpha (VEGF-A). It helps to make the mFOLFOX6 more effective. Giving riluzole, mFOLFOX6, and bevacizumab may kill more tumor cells

Who is the study for?
This trial is for adults with metastatic colorectal cancer who can receive mFOLFOX6/bevacizumab and have adequate organ function. They must understand the study, agree to use contraception, and be willing to undergo tumor biopsies. Excluded are those with hepatitis B/C, severe kidney issues, certain heart conditions, uncontrolled blood pressure or illness that affects compliance.Check my eligibility
What is being tested?
The trial tests riluzole combined with standard chemotherapy (mFOLFOX6) and bevacizumab against metastatic colorectal cancer. It aims to determine the best dose of riluzole and its effectiveness in enhancing chemotherapy's impact on tumor cells.See study design
What are the potential side effects?
Possible side effects include reactions related to immune system suppression such as increased risk of infection, liver toxicity indicated by elevated bilirubin levels, nerve damage presenting as peripheral neuropathy, fatigue from anemia due to low hemoglobin levels, and bleeding risks associated with low platelet counts.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am using birth control and have a negative pregnancy test.
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I am 18 years old or older.
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I am fully active or can carry out light work.
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I agree to have tissue samples taken before and after treatment to confirm my colorectal cancer.
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My liver enzymes are within the normal range for my condition.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 of cycle 1,3,5,7 (each cycle is 14 days)
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 of cycle 1,3,5,7 (each cycle is 14 days) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Dose limiting toxicities (DLTs)
Secondary outcome measures
Pharmacokinetic (PK) profile of riluzole (AUC)
Pharmacokinetic (PK) profile of riluzole (Cmax)
Other outcome measures
C-reactive protein
Change in FCGRT/FcRn expression
Change in bevacizumab clearance (AUC)
+13 more

Side effects data

From 2008 Phase 4 trial • 26 Patients • NCT00419003
38%
Fatigue
38%
Headache
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Placebo Pre-Treatment
Lamotrigine Pre-Treatment
Riluzole Group
Ketamine

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (riluzole, mFOLFOX6, bevacizumab)Experimental Treatment5 Interventions
Patients receive riluzole PO BID on days 1-14. Patients also receive oxaliplatin via IVPB over 2 hours, leucovorin calcium IVPB over 2 hours, and bevacizumab IVPB over 30 minutes on day 1 and fluorouracil via IV push over 5 minutes and then IV continuously over 46 hours on days 1-2. Treatment repeats every 2 weeks for up to 8 cycles in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bevacizumab
2013
Completed Phase 4
~5280
Leucovorin Calcium
2011
Completed Phase 3
~12290
Oxaliplatin
2011
Completed Phase 4
~2560
Fluorouracil
2014
Completed Phase 3
~11540
Riluzole
2006
Completed Phase 4
~2780

Find a Location

Who is running the clinical trial?

Ning JinLead Sponsor
Ning Jin, MDPrincipal InvestigatorOhio State University Comprehensive Cancer Center

Media Library

Bevacizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04761614 — Phase 1
Colorectal Cancer Research Study Groups: Treatment (riluzole, mFOLFOX6, bevacizumab)
Colorectal Cancer Clinical Trial 2023: Bevacizumab Highlights & Side Effects. Trial Name: NCT04761614 — Phase 1
Bevacizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04761614 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what applications is Riluzole usually applied?

"Riluzole is often utilized to treat renal impairment, but it has also been demonstrated effective in treating a variety of other diseases such as joint issues, rectal cancer, and advanced stages of non-squamous non-small cell lung cancer."

Answered by AI

Is this research endeavor currently recruiting participants?

"Affirmative. Clinicaltrials.gov shows that this medical study is currently enrolling participants, with an original posting date of April 2nd 2021 and a most recent update on December 14th 2021. A total of 15 people are needed across one clinical site."

Answered by AI

What is the current population size of participants in this clinical investigation?

"Affirmative, the information available on clinicaltrials.gov suggests this medical trial is actively soliciting volunteers. It was first made available to view on April 2nd 2021 and most recently updated December 14th 2021. A total of 15 individuals are needed across a single research centre."

Answered by AI

Has Riluzole been sanctioned by the FDA?

"Riluzole has only undergone Phase 1 trials, so its safety is rated at a conservative level of one. There are few studies supporting the efficacy and safety of this drug."

Answered by AI

Are there any precedent research projects concerning Riluzole?

"Currently, 843 clinical trials are researching the efficacy of Riluzole. 260 of these active studies have moved to Phase 3 testing and 37472 medical centres around the world are participating in this research endeavour. Guangzhou, Guangdong is particularly involved with many different trial sites located there."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Riluzole in Combination With mFOLFOX6 and Bevacizumab in Treating Patients With Metastatic Colorectal Cancer
Ning Jin 2021. "Riluzole in Combination With mFOLFOX6 and Bevacizumab in Treating Patients With Metastatic Colorectal Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04761614.
~3 spots leftby Apr 2025
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