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Radioactive Drug
Triapine + Radiation Therapy for Neuroendocrine Cancer
Phase 1
Waitlist Available
Led By Aman Chauhan
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up time from registration to time of progressive disease as defined by response evaluation criteria in solid tumors 1.1 criteria or death from any cause, whichever occurs first, assessed up to 24 months
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing the side effects and best dose of triapine when given with lutetium Lu 177 dotatate for neuroendocrine tumors. Triapine may stop tumor growth by blocking enzymes needed for cell growth. Lutetium Lu 177 dotatate is a radioactive drug that carries radiation directly to tumor cells. Giving triapine and lutetium Lu 177 dotatate together may be a good way to treat neuroendocrine tumors.
Who is the study for?
Adults with well-differentiated neuroendocrine tumors and positive dotatate scans who have failed at least one cancer treatment. They must show disease progression, have measurable disease, be in good physical condition (ECOG 0-2), and meet specific blood criteria. Excluded are those under 18, pregnant or breastfeeding women, recent major surgery patients, individuals unable to absorb oral meds properly, anyone with uncontrolled heart failure or other serious illnesses.
What is being tested?
The trial is testing the combination of Triapine and Lutetium Lu 177 Dotatate for treating neuroendocrine tumors. Triapine blocks enzymes needed for tumor growth while Lutetium Lu 177 Dotatate delivers radiation directly to tumor cells. The study aims to find the best dose and assess side effects.
What are the potential side effects?
Potential side effects include reactions related to blocking cell growth enzymes by Triapine and radiation exposure from Lutetium Lu 177 Dotatate which may affect normal cells despite its targeted approach. Specific side effects will be monitored as part of determining the safest effective dose.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ time from registration to time of progressive disease as defined by response evaluation criteria in solid tumors 1.1 criteria or death from any cause, whichever occurs first, assessed up to 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~time from registration to time of progressive disease as defined by response evaluation criteria in solid tumors 1.1 criteria or death from any cause, whichever occurs first, assessed up to 24 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Dose limiting toxicity (DLT)
Maximum tolerated dose (MTD) of triapine and recommended phase 2 dose (RP2D)
Secondary study objectives
Overall response rate (ORR)
Overall survival
Progression free survival (PFS)
Other study objectives
Change in deoxyribonucleoside concentrations
Expression of somatostatin receptors
Krenning score from the gallium 68 dotatate
+2 moreAwards & 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 (lutetium Lu 177 dotatate, triapine)Experimental Treatment5 Interventions
Patients receive lutetium Lu 177 dotatate IV for 30 to 40 minutes on day 1 of each cycle and triapine PO on days 1 throughout 14 of each cycle. Cycles repeat every 56 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan or MRI scan throughout the trial. Patients undergo blood specimen collection on study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biospecimen Collection
2004
Completed Phase 3
~2020
Magnetic Resonance Imaging
2017
Completed Phase 3
~1160
Computed Tomography
2017
Completed Phase 2
~2740
Triapine
2006
Completed Phase 1
~30
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,925 Previous Clinical Trials
41,017,972 Total Patients Enrolled
81 Trials studying Neuroendocrine Tumors
43,744 Patients Enrolled for Neuroendocrine Tumors
Aman ChauhanPrincipal InvestigatorOhio State University Comprehensive Cancer Center LAO
2 Previous Clinical Trials
123 Total Patients Enrolled
2 Trials studying Neuroendocrine Tumors
123 Patients Enrolled for Neuroendocrine Tumors
Susanne M ArnoldPrincipal InvestigatorOhio State University Comprehensive Cancer Center LAO
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer has spread, is well-differentiated, and had a positive dotatate scan recently.I am HIV positive, on treatment, and my viral load has been undetectable for the last 6 months.I cannot swallow pills or have a gut condition affecting medication absorption.I do not have any uncontrolled illnesses like severe infections or heart problems.My cancer has worsened according to recent scans.I am not pregnant or breastfeeding.I can take care of myself but may not be able to do heavy physical work.I have recovered from side effects of previous cancer treatments, except for hair loss.I have not had major surgery in the last 6 weeks.I haven't had chemotherapy or radiotherapy in the last 4 weeks.Less than half of my bone marrow has been exposed to radiation.I am allergic to medications similar to triapine or lutetium Lu 177 dotatate.I have a recent tissue sample or am willing to provide one for study.I have never had peptide receptor radionuclide therapy.I am 18 years old or older.My kidney function, measured by GFR, is good.I had hepatitis C but have been treated and cured.I can understand and am willing to sign the consent form, or I have someone who can do it for me.I do not have severe heart failure.My brain scans show no worsening after treatment for brain metastases.My hepatitis B virus load is undetectable with treatment.I will avoid pregnancy or causing pregnancy for 7 months after my last lutetium Lu 177 dotatate treatment.I have recovered from side effects of previous treatments to mild levels.I haven't taken long-acting somatostatin analogs for 4 weeks, unless needed for carcinoid syndrome.I have tried at least one cancer treatment without success.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (lutetium Lu 177 dotatate, triapine)
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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