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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
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

Study 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.Check my eligibility
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.See study design
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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I have advanced cancer in the digestive system and am eligible for radiation therapy for symptom relief without other simultaneous treatments.
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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.
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I haven't had chemotherapy in the last 4 weeks and no prior radiation at the tumor site for this study.

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
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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Maximum tolerated dose (MTD) defined as the dose below which 2 or more of 6 patients experience dose-limiting toxicity
Secondary outcome measures
%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

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

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,609 Previous Clinical Trials
40,915,627 Total Patients Enrolled
Timothy J KinsellaPrincipal InvestigatorRhode Island Hospital
1 Previous Clinical Trials
1 Total Patients Enrolled

Media Library

Pharmacological Study Clinical Trial Eligibility Overview. Trial Name: NCT02381561 — Phase 1
Pancreatic Cancer Research Study Groups: Treatment (ropidoxuridine, IMRT)
Pancreatic Cancer Clinical Trial 2023: Pharmacological Study Highlights & Side Effects. Trial Name: NCT02381561 — Phase 1
Pharmacological Study 2023 Treatment Timeline for Medical Study. Trial Name: NCT02381561 — Phase 1

Frequently Asked Questions

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

Has the Pharmacological Study been certified by the FDA?

"There is limited evidence of safety and efficacy for this pharmacological study, thus receiving a score of 1 on our scale."

Answered by AI

What is the current enrolment size of this clinical experiment?

"This trial is no longer enrolling patients - the initial posting was in February 2016, and it has not been updated since September 2022. However, 2017 studies with stage IV small intestinal cancer AJCC V7 are currently recruiting participants as well as 3 trials seeking those interested to partake in Pharmacological Studies."

Answered by AI

Is this research endeavor open to new participants?

"At this point, no further participants are being sought for the clinical trial. It was initially posted on February 1st 2016 and last updated September 20th 2022. However, if you're in search of other studies, 2017 medical trials are actively recruiting patients diagnosed with stage iv small intestinal cancer ajcc v7 while 3 pharmacological studies remain open to new admissions."

Answered by AI

What other research has been conducted regarding the pharmacological impact of this substance?

"Presently, 3 clinical trials are underway assessing Pharmacological Study. None have progressed to Phase 3 yet. Of the 24 locations conducting research on this drug, most are located in Providence, Rhode island."

Answered by AI
~2 spots leftby Mar 2025