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Triapine + Radiation Therapy for Neuroendocrine Cancer
Study 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.
Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- 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.
- Group 1: Treatment (lutetium Lu 177 dotatate, triapine)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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.
Frequently Asked Questions
What other research has been conducted into the effects of Triapine?
"Currently, 2 Phase 3 trials involving Triapine are ongoing in addition to 24 other studies. Most of these medical tests originate from the New york City area but there are nearly 600 sites worldwide running their own examinations on this medication."
Is enrollment still possible for this research endeavor?
"Per the clinicaltrials.gov website, this medical trial is currently in need of study subjects. The initiation date was June 29th 2020 and recent changes to protocol were made November 30th 2022."
Has Triapine obtained regulatory approval from the FDA?
"The safety of Triapine was assessed as a 1 on our scale, denoting that this is an early clinical trial stage and there are only limited data points to support its efficacy and safety."
How many individuals have opted to partake in this experiment thus far?
"Affirmative. Evidence from clinicaltrials.gov indicates that this medical experiment, which was originally posted on June 29th 2020, is still accepting applicants. In total, the study has to enlist 29 individuals from 9 different clinical sites."
How many different facilities are overseeing this trial?
"Currently, this trial is enrolling participants at 9 different medical centres located in cities such as Rochester and Phoenix. To reduce travel needs, it is important to choose the site nearest you when considering participation. Duarte and other locations are also available."
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