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Peptide Receptor Radionuclide Therapy
Peptide Receptor Radionuclide Therapy for Neuroblastoma
Phase 1 & 2
Recruiting
Research Sponsored by Clarity Pharmaceuticals Ltd
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Karnofsky or Lansky performance status ≥50
64Cu-SARTATE uptake on the 4 hour scan (SUVmax) of any lesion equal to or higher than that of the liver in order to move on to the therapy phase of the study
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 36 months
Awards & highlights
Study Summary
This trial is testing a new treatment for neuroblastoma, a cancer that typically affects young children. The goal is to see if it is safe and effective.
Who is the study for?
This trial is for pediatric patients with high-risk neuroblastoma that's relapsed or not responding to standard treatments. They must have a life expectancy of at least 12 weeks, adequate organ function, and a minimum performance status of 50. Participants need available stem cells for transplant and must use effective birth control if applicable.Check my eligibility
What is being tested?
The study tests the safety and effectiveness of a therapy called 67Cu-SARTATE in children with aggressive neuroblastoma. Patients first undergo a scan using 64Cu-SARTATE to ensure their tumors absorb the drug well enough before receiving the actual treatment.See study design
What are the potential side effects?
While specific side effects are not listed here, potential risks may include reactions related to radiation exposure from the radionuclide therapy such as nausea, fatigue, kidney damage, blood cell count changes, and possible allergic reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can do most activities but may need help.
Select...
My scan shows a lesion as active as or more than my liver.
Select...
I have a stem cell product ready for use with enough cells.
Select...
My liver tests, AST and ALT, are within normal limits.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 36 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 36 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Best response
Maximum Tolerated Dose (MTD) of 67Cu-SARTATE
Overall response rate
+2 moreSide effects data
From 2020 Phase 4 trial • 711 Patients • NCT021750305%
Adverse events experienced related to IUD at 1-Month
100%
80%
60%
40%
20%
0%
Study treatment Arm
Copper T380 IUD
LNG20 IUD
Trial Design
1Treatment groups
Experimental Treatment
Group I: 67Cu-SARTATEExperimental Treatment2 Interventions
64Cu-SARTATE - patients will receive a bolus injection of 64Cu-SARTATE during screening, and following each 67Cu-SARTATE Therapy Cycle at a rate of 2.0 MBq/kg.
67Cu-SARTATE - In the dose escalation phase, patients will receive a single administration of 67Cu-SARTATE as an IV infusion (dose will be determined based on cohort allocation). In the expansion phase, patients will receive at least 2 administrations of 67Cu-SARTATE a the MTD level as a slow IV infusion.
Participants in either phase of the study that demonstrate therapeutic benefit following treatment with 67Cu-SARTATE at any dose may be offered additional Therapy Cycles (each participant may receive a maximum of 4 Therapy Cycles in total).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
64Cu-SARTATE
2015
Completed Early Phase 1
~10
Find a Location
Who is running the clinical trial?
Clarity Pharmaceuticals LtdLead Sponsor
10 Previous Clinical Trials
704 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can do most activities but may need help.I received a specific radioactive treatment within the last 8 weeks.My major organs are healthy enough to handle the treatment.My neuroblastoma is high-risk and hasn't fully responded to standard treatments.I am over 18 and can consent, or if under 18, my guardian can consent for me.I have undergone peptide receptor radionuclide therapy.My scan shows a lesion as active as or more than my liver.I am older than 12 months and eligible for treatments with higher radiation doses.I have not had radiation therapy to my kidneys in the last year.I have received somatostatin analogues recently.I am using or willing to use birth control or practice abstinence during the study.I have a history of heart failure with symptoms like shortness of breath or needing oxygen.You have a known sensitivity or allergy to somatostatin analogues.I will not start new cancer treatments within 2 weeks before receiving 64Cu-SARTATE.My kidney function is normal.I am not pregnant or breastfeeding.I am currently receiving hemodialysis.I have a stem cell product ready for use with enough cells.My liver tests, AST and ALT, are within normal limits.I have not had any other cancer in the last 3 years.I do not have any infections that are currently uncontrolled.
Research Study Groups:
This trial has the following groups:- Group 1: 67Cu-SARTATE
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there similar ongoing research projects to this one involving 67Cu-SARTATE?
"City of Hope Medical Center first studied 67Cu-SARTATE in 2015. Since then, there have been 19 completed clinical trials and presently 7 active studies. A high concentration of these ongoing trials are based out of Dallas, Texas."
Answered by AI
In how many different geographical locations is this trial being run today?
"This trial has 9 enrolment sites, which are hospitals and medical centres located across the United States of America. The locations include University of Texas Southwestern Medical Centre in Dallas, Phoenix Children's Hospital in Phoenix, and Medical University of South carolina in Charleston."
Answered by AI
How many people fit the qualifications for this experiment?
"In order to complete this study 34 patients that meet the inclusion criteria are required. The sponsor, Clarity Pharmaceuticals Ltd, will be conducting the trial at different locations including University of Texas Southwestern Medical Centre in Dallas, Texas and Phoenix Children's Hospital in Phoenix, Arizona."
Answered by AI
To what conditions does 67Cu-SARTATE commonly lend therapeutic relief?
"67Cu-SARTATE is most commonly used as an intervention for trace element deficiency. It can also be prescribed to treat a variety of other conditions including obesity, IUD therapy, and IUD insertion."
Answered by AI
Are new test subjects currently being accepted for this experiment?
"The trial is recruiting patients, as shown by the listing on clinicaltrials.gov. It was posted on 8/18/2020, with the latest update being 6/29/2022. The study seeks to enroll 34 participants at 9 sites."
Answered by AI
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