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Radiopharmaceutical
Targeted Radiotherapy for Brain Tumor
Phase 1
Recruiting
Research Sponsored by Cellectar Biosciences, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed throughout the study to 1-year post-infusion follow-up period
Awards & highlights
No Placebo-Only Group
Summary
This trial tests higher doses of a new drug to see if it is safe and effective for treating kids, teens, and young adults with HGG.
Who is the study for?
This trial is for children, adolescents, and young adults aged 2-25 with high-grade glioma (a type of brain tumor) that has come back or hasn't responded to treatment. They must be in a stable condition, not pregnant, able to follow the study plan, and have certain blood counts and organ functions within specific ranges.
What is being tested?
The trial is testing two different doses of CLR 131 to see how safe it is and if it works against relapsed or refractory high-grade gliomas in pediatric patients. It's a dose-finding study which means they're trying to find the right amount of drug that's effective but also safe.
What are the potential side effects?
While the exact side effects are not listed here, similar targeted radiotherapies can cause nausea, fatigue, loss of appetite, hair loss at the site of treatment. There may also be risks associated with radiation exposure such as damage to healthy tissue.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ assessed throughout the study to 1-year post-infusion follow-up period
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed throughout the study to 1-year post-infusion follow-up period
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Efficacy Evaluation for Progression Free Survival
Safety Evaluation of CLR 131
Secondary study objectives
Dose Determination for CLR 131
Dosimetry Evaluation for Total Body and Organ
Treatment Response of CLR 131
+1 moreSide effects data
From 2024 Phase 1 trial • 12 Patients • NCT0410554392%
White blood cell decreased
83%
Lymphocyte count decreased
83%
Neutrophil count decreased
83%
Anemia
75%
Platelet count decreased
67%
Fatigue
50%
Mucositis oral
50%
Dermatitis radiation
42%
Dry mouth
42%
Anorexia
33%
Dysphagia
33%
Weight loss
33%
Headache
25%
Nausea
25%
Oral Pharyngeal pain
25%
Hypotension
17%
Mucosal infection
17%
Febrile neutropenia
17%
Dizziness
17%
Pain
17%
Dysgeusia
17%
Constipation
8%
Syncope
8%
Tumor hemorrhage
8%
Depression
8%
Salivary duct inflammation
8%
Watering eyes
8%
Vomiting
8%
Epistaxis
8%
Respiratory failure
8%
Diarrhea
8%
Neck Pain
8%
Aspiration
8%
Neuralgia
8%
Stridor
8%
Fever
8%
Neck edema
8%
Thrush
8%
Tinnitus
8%
Dehydration
8%
Trismus
8%
Paresthesia
8%
Chills
8%
Erythema multiforme
8%
Dyspnea
8%
Thyroid stimulating hormone increased
8%
Rash Maculo-papular
8%
Fibrosis deep connective tissue
8%
Osteonecrosis of jaw
8%
Tumor pain
8%
Dry eye
8%
Superficial thrombophlebitis
8%
Dysarthria
8%
Metabolism and nutrition disorders - Other, specify
8%
Hypoxia
8%
Hypertension
8%
Laryngitis
8%
Lymphedema
100%
80%
60%
40%
20%
0%
Study treatment Arm
CLR 131 Dose Escalation
Awards & 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: Pediatric High-Grade Glioma PatientsExperimental Treatment1 Intervention
Two dosing cohorts will be explored; patients in the first arm will receive two doses, 20 mCi/m2 each, separated by 14 days for two cycles, with a third optional cycle. Patients in the second arm will receive two doses, 10 mCi/m2 each, separated by 14 days for three cycles with a fourth optional cycle.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CLR 131
2019
Completed Phase 1
~20
Find a Location
Who is running the clinical trial?
Cellectar Biosciences, Inc.Lead Sponsor
14 Previous Clinical Trials
1,215 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,958 Previous Clinical Trials
41,112,530 Total Patients Enrolled
Jarrod LongcorStudy DirectorChief Operating Officer
2 Previous Clinical Trials
150 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 10 and 25 years old.I haven't had cancer treatment or experimental therapy recently.I am mostly able to care for myself and carry out daily activities.I have HIV or a serious infection that is not under control.My hemoglobin level is at least 8 g/dL, and I haven't had a blood transfusion in the last week.I am on a stable or decreasing dose of steroids for brain symptom management.My platelet count is at least 75,000 and I haven't had a transfusion in the last week.I haven't had major surgery in the last 6 weeks or delaying it is too risky.I do not have any serious illness that could affect my safety or interfere with the drug's evaluation.My high grade brain tumor is suspected to have come back or not responded to treatment.I am a woman who can have children and have a negative pregnancy test.
Research Study Groups:
This trial has the following groups:- Group 1: Pediatric High-Grade Glioma Patients
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.