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Ropidoxuridine for Gastrointestinal Cancer

Phase 1

Waitlist Available

Led By Timothy J Kinsella

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

Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)

Human immunodeficiency virus (HIV) positive (+) patients with cluster of differentiation 4 (CD4) counts >= 250 cells/mm^3 on anti-viral therapy

Must not have

Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

Patients with known brain metastases should be excluded from this clinical trial

Timeline

Screening 3 weeks

Treatment Varies

Follow Up days 1, 15 and 22 before drug administration, 30, 60, 120, and 240 minutes (and 24 hours on day 1 only) following drug administration

Awards & highlights

No Placebo-Only Group

Summary

This trial looks at the side effects and best dosage of a drug that may make radiation therapy more effective for patients with gastrointestinal cancer.

Who is the study for?

This trial is for adults with advanced, incurable gastrointestinal cancers such as esophageal, liver, stomach, small bowel, pancreas, bile duct, colon or rectum cancer. They must not have had chemotherapy or radiation at the tumor site within 4 weeks and should have a life expectancy over 12 weeks. Participants need normal blood counts and organ function tests and agree to use contraception.

What is being tested?

The study is testing ropidoxuridine's safety and optimal dosage in combination with radiation therapy to see if it makes cancer cells more sensitive to treatment. It's a phase I trial which means it's early in the testing process focusing on finding the right dose that’s safe.

What are the potential side effects?

Potential side effects of ropidoxuridine are not detailed but may include typical reactions related to enhancing radiation therapy sensitivity like increased skin irritation or fatigue. Side effects will be closely monitored given this is a dose-finding study.

Eligibility Criteria

Inclusion Criteria

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

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I can take care of myself but might not be able to do heavy physical work.

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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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My kidney function, measured by creatinine or its clearance, is within the normal range.

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I am a woman who can have children and my pregnancy test is negative.

Exclusion Criteria

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

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I do not have any severe illnesses or social situations that would stop me from following the study's requirements.

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I do not have brain metastases.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ days 1, 15 and 22 before drug administration, 30, 60, 120, and 240 minutes (and 24 hours on day 1 only) following drug administration

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~days 1, 15 and 22 before drug administration, 30, 60, 120, and 240 minutes (and 24 hours on day 1 only) following drug administration

This trial's timeline: 3 weeks for screening, Varies for treatment, and days 1, 15 and 22 before drug administration, 30, 60, 120, and 240 minutes (and 24 hours on day 1 only) following drug administration for reporting.

Treatment Details

Study Objectives

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

Secondary study objectives

%iododeoxyuridine (IUdR)-deoxyribonucleic acid (DNA) incorporation in peripheral (circulating) granulocytes

%iododeoxyuridine (IUdR)-deoxyribonucleic acid (DNA) incorporation in tumor biopsies

Pharmacokinetic (PK) incorporation in peripheral (circulating) granulocytes

+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, IMRT)Experimental Treatment4 Interventions

Beginning 30 minutes to 2 hours before radiation therapy, patients receive ropidoxuridine PO QD on days 1-28 in the absence of disease progression or unacceptable toxicity. Beginning on day 8, patients undergo IMRT 5 days a week for 3 weeks in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Intensity-Modulated Radiation Therapy

2010

Completed Phase 3

~2160

0 / 6Eligibility criteria met