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Ropidoxuridine + Whole Brain Radiation Therapy for Brain Metastasis

Phase 1

Waitlist Available

Led By Pranshu Mohindra

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

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

Must have

Calculated creatinine clearance >= 45 mL/min/1.73 m^2

HIV positive (+) patients with CD4 counts >= 250 cells/mm^3 on anti-viral therapy are eligible for the study

Must not have

Patients needing more than 8 mg dexamethasone per day at the time of start of WBRT

Presence of diffuse lepto or pachy meningeal carcinomatosis, greater than 1 cm mid-line shift, uncal herniation, or severe hemorrhage/hydrocephalous

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial studies the side effects and best dose of ropidoxuridine when given with whole brain radiation therapy for brain metastases.

Who is the study for?

This trial is for patients with cancer that has spread to the brain. They must be in a stable condition, have good organ function, and not have had whole brain radiation before. People with primary germ cell tumors or leukemia/lymphoma, pregnant women, those on high-dose steroids or recent chemotherapy are excluded.

What is being tested?

The study is testing ropidoxuridine combined with whole brain radiation therapy (WBRT) to see if it improves treatment outcomes for brain metastases. It aims to find the safest dose of ropidoxuridine that works best alongside WBRT.

What are the potential side effects?

Potential side effects include increased sensitivity of cancer cells to radiation which may lead to enhanced damage both in tumor and possibly some healthy tissues; specific side effects will be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My kidneys are functioning well enough (creatinine clearance rate is good).

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I am HIV positive with a CD4 count of 250 or higher and on anti-viral therapy.

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I am mostly self-sufficient and can carry out daily activities.

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My cancer has spread to my brain, and I am advised to undergo whole brain radiation therapy.

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My bilirubin levels are within the normal range for my condition.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I need more than 8 mg of dexamethasone daily before starting whole brain radiation therapy.

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I have severe brain complications due to cancer spread.

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I have had whole brain radiation therapy before.

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My cancer is a type of germ cell tumor, lymphoma, or leukemia.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Number of Participants Experiencing a Dose Limiting Toxicity

Secondary study objectives

Intracranial Disease Status

Number of Participants Experience Grade 3, 4, or 5 Adverse Events

Number of Participants With Complete Response, Partial Response, Stable Disease or Progressive Disease.

+2 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (ropidoxuridine, WBRT)Experimental Treatment5 Interventions

Patients receive ropidoxuridine PO QD on days 1-28 and undergo WBRT daily for not more than 5 days per week beginning on day 8 for a total of 15 fractions in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Whole-Brain Radiotherapy

2012

Completed Phase 2

~150

0 / 9Eligibility criteria met