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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of Participants Experiencing a Dose Limiting Toxicity

Secondary outcome measures

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

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 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,658 Previous Clinical Trials

40,924,478 Total Patients Enrolled

Pranshu MohindraPrincipal InvestigatorMayo Clinic Cancer Center LAO

1 Previous Clinical Trials

15 Total Patients Enrolled

Media Library

Whole-Brain Radiotherapy Clinical Trial Eligibility Overview. Trial Name: NCT02993146 — Phase 1

Brain Metastasis Research Study Groups: Treatment (ropidoxuridine, WBRT)

Brain Metastasis Clinical Trial 2023: Whole-Brain Radiotherapy Highlights & Side Effects. Trial Name: NCT02993146 — Phase 1

Whole-Brain Radiotherapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT02993146 — Phase 1

Frequently Asked Questions

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

What is the participant count in this clinical experiment?

"This research project is not currently recruiting volunteers, as the last data update was on August 24th 2022. If you are searching for alternate studies, there are 2735 clinical trials actively seeking participants with brain cancer and 3 trials involving Ropidoxuridine that need patients to enrol."

Answered by AI

Has Ropidoxuridine been accorded authorization by the FDA?

"Taking into account the limited evidence for efficacy and safety of Ropidoxuridine, our team has awarded it a score of 1 on a scale from 1 to 3."

Answered by AI

Is this experiment currently accessible to participants?

"At this time, the information on clinicaltrials.gov states that no new patients are being recruited for this trial, which was initially posted in December of 2016 and last updated in August 2022. However, there is still an abundance of other studies actively seeking participants - 2738 to be exact."

Answered by AI

What precedent does Ropidoxuridine have in terms of clinical experiments?

"Presently, there are 3 studies concerning Ropidoxuridine underway. None of these analyses have progressed to Phase 3 yet. While the majority of research into this drug is based in Providence, Rhode island, it has been tested at 24 separate sites across the country."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Ropidoxuridine and Whole Brain Radiation Therapy in Treating Patients With Brain Metastases

2017. "Ropidoxuridine and Whole Brain Radiation Therapy in Treating Patients With Brain Metastases". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02993146.

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