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Radioconjugate
Triapine + Targeted Radiation for Neuroendocrine Cancer
Phase 2
Recruiting
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 up to 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial compares the effect of adding a drug to a radioactive medication to shrink or slow tumor growth in metastatic neuroendocrine tumors.
Who is the study for?
Adults with well-differentiated, metastatic neuroendocrine tumors that have progressed despite previous treatments can join. They must not have lung NETs, prior peptide receptor radionuclide therapy, or significant uncontrolled conditions. Eligible participants need functioning major organs and controlled hepatitis if present. Pregnant or breastfeeding women are excluded.
What is being tested?
The trial is testing the addition of Triapine to Lutetium Lu 177 Dotatate treatment for shrinking or slowing tumor growth in metastatic neuroendocrine tumors compared to using Lutetium Lu 177 Dotatate alone.
What are the potential side effects?
Possible side effects include reactions related to blocking enzymes needed for DNA synthesis and cell growth due to Triapine, as well as radiation effects from Lutetium Lu 177 Dotatate which may cause damage to cells where it accumulates.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Overall response rate
Secondary study objectives
Progression free survival (PFS)
Other study objectives
Circulating deoxyribonucleic acid (ctDNA)
Plasma deoxyribonucleosides
Plasma hPG80
+5 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm 1 (triapine, lutetium Lu 177 dotatate)Experimental Treatment5 Interventions
Patients receive triapine PO on days 1-14 of each cycle and lutetium Lu 177 dotatate IV over 30 minutes on day 1 of each cycle. Cycles repeat every 8 weeks for 4 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and/or MRI and collection of blood samples throughout the trial.
Group II: Arm 2 (lutetium Lu 177 dotatate)Active Control4 Interventions
Patients receive lutetium Lu 177 dotatate IV over 30 minutes on day 1 of each cycle. Cycles repeat every 8 weeks for 4 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and/or MRI and collection of blood samples throughout the trial.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Computed Tomography
2017
Completed Phase 2
~2740
Biospecimen Collection
2004
Completed Phase 3
~2020
Magnetic Resonance Imaging
2017
Completed Phase 3
~1160
Triapine
2006
Completed Phase 1
~30
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,917 Previous Clinical Trials
41,014,359 Total Patients Enrolled
81 Trials studying Neuroendocrine Tumors
43,679 Patients Enrolled for Neuroendocrine Tumors
Aman ChauhanPrincipal InvestigatorOhio State University Comprehensive Cancer Center LAO
2 Previous Clinical Trials
58 Total Patients Enrolled
2 Trials studying Neuroendocrine Tumors
58 Patients Enrolled for Neuroendocrine Tumors
Lowell B AnthonyPrincipal InvestigatorOhio State University Comprehensive Cancer Center LAO
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am allergic to medications similar to triapine or lutetium Lu 177 dotatate.I have recovered from side effects of my previous treatments.I have recovered from side effects of past treatments, except for hair loss.I can take care of myself but may not be able to do heavy physical work.I have tried a somatostatin analog treatment for my cancer without success.I am not pregnant or breastfeeding.I will avoid pregnancy or fathering a child for 7 months after my last treatment.My cancer has grown despite treatment, confirmed by scans in the last 24 months.My heart condition is not under control and severely limits my daily activities.I have never had peptide receptor radionuclide therapy.My brain scans show no cancer growth 4 weeks after treatment, and I'm not on steroids.I have another cancer, but it won't affect this trial's treatment.My heart function is classified as class 2B or better according to the NYHA.My hepatitis B virus load is undetectable with treatment.I had hepatitis C but am cured, or I'm being treated with no detectable virus.I am 18 years old or older.I have a specific type of cancer that has spread and shows up on certain scans, but it's not in my lungs.I am HIV positive, on treatment, and my viral load is undetectable.I cannot swallow pills or have a gut condition affecting medication absorption.My kidney function, measured by creatinine levels, is within the normal range or slightly above.
Research Study Groups:
This trial has the following groups:- Group 1: Arm 1 (triapine, lutetium Lu 177 dotatate)
- Group 2: Arm 2 (lutetium Lu 177 dotatate)
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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