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Amino Acid Supplement

Arginine + Radiotherapy for Cancer Spread to the Brain

Phase < 1

Recruiting

Led By Lisa Sudmeier, MD, PhD

Research Sponsored by Emory University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to find the best way to give arginine to patients with cancer that has spread to the brain. Arginine is a type of amino acid that can help improve how brain metastases respond

Who is the study for?

This trial is for patients with cancer that has spread to the brain. Participants must be able to undergo procedures like CT scans, MRI, and radiation therapy. The study will test if arginine, an essential amino acid, can improve how brain metastases respond to radiation.

What is being tested?

The trial is evaluating oral or intravenous administration of arginine combined with whole-brain radiotherapy in treating brain metastases from primary cancers. It aims to find the best dosing strategy by measuring blood levels of arginine before and after administration.

What are the potential side effects?

Potential side effects may include reactions related to arginine supplementation such as gastrointestinal discomfort or changes in blood pressure, as well as typical risks associated with radiation therapy like fatigue, hair loss at treatment sites, and skin irritation.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Peak plasma L-arginine (arginine) and arginine metabolite concentration

Secondary study objectives

Describe The Immunological Effects of Oral versus IV Arginine

Describe The Metabolic Effects of Oral versus IV Arginine

Frontal cortex blood volume/flow changes with L-arginine administration

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm B (oral L-arginine, WBRT)Experimental Treatment6 Interventions

Patients receive L-arginine PO followed by WBRT approximately 1 hour later for up to 10 days of treatment over 2 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo CT at screening, undergo collection of blood samples and spectroscopy on study, and undergo MRI at screening and follow up.

Group II: Arm A (IV L-arginine, WBRT)Experimental Treatment6 Interventions

Patients receive L-arginine IV over 10-20 minutes followed by WBRT approximately 1 hour later for up to 10 days of treatment over 2 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo CT at screening, undergo collection of blood samples and spectroscopy on study, and undergo MRI at screening and follow up.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Magnetic Resonance Imaging

2017

Completed Phase 3

~1180

Biospecimen Collection

2004

Completed Phase 3

~2030