Ropidoxuridine + Whole Brain Radiation Therapy for Brain Metastasis

Recruiting in Palo Alto (17 mi)

+13 other locations

Overseen byPranshu Mohindra

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Approved in 6 Jurisdictions

Trial Summary

What is the purpose of this trial?

This phase I trial studies the side effects and best dose of ropidoxuridine when given together with whole brain radiation therapy in treating patients with cancer that has spread to the brain (brain metastases). Ropidoxuridine may help whole brain radiation therapy work better by making cancer cells more sensitive to the radiation therapy.

Eligibility Criteria

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.

Inclusion Criteria

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

Ability to understand and the willingness to sign a written informed consent document

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

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Exclusion Criteria

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

I do not have any severe illnesses that could worsen due to the study or prevent me from following the study requirements.

I have severe brain complications due to cancer spread.

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Treatment Details

Interventions

Ropidoxuridine (Radiosensitizer)
Whole-Brain Radiotherapy (Radiation)

Trial OverviewThe 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.

Participant Groups

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.

Whole-Brain Radiotherapy is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

🇪🇺 Approved in European Union as Whole-Brain Radiation Therapy for: