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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
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 belowSelect...
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.
Select...
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:Select...
I do not have any severe illnesses or social situations that would stop me from following the study's requirements.
Select...
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
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 moreTrial 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
13,842 Previous Clinical Trials
41,002,981 Total Patients Enrolled
Timothy J KinsellaPrincipal InvestigatorRhode Island Hospital
1 Previous Clinical Trials
1 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your bilirubin levels are within the normal range for the hospital or clinic where you are being treated.I do not have any severe illnesses or social situations that would stop me from following the study's requirements.I can take care of myself but might not be able to do heavy physical work.Your white blood cell count is at least 3,000 per microliter.I am HIV positive with a CD4 count of 250 or higher and on anti-viral therapy.I have advanced cancer in the digestive system and am eligible for radiation therapy for symptom relief without other simultaneous treatments.My kidney function, measured by creatinine or its clearance, is within the normal range.I am a woman who can have children and my pregnancy test is negative.I haven't had chemotherapy in the last 4 weeks and no prior radiation at the tumor site for this study.You are expected to live for more than 12 weeks.I do not have brain metastases.You are currently taking any experimental drugs.You have enough white blood cells called neutrophils in your body.I haven't had chemotherapy or radiotherapy in the last 4 weeks, or I've recovered from its side effects.Your platelet count is at least 100,000 per microliter.Your liver enzyme levels are not more than 2.5 times the normal range.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (ropidoxuridine, IMRT)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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