Trial Title:
Novel Targeted Radiotherapy in Pediatric Patients With Inoperable Relapsed or Refractory HGG
NCT ID:
NCT05610891
Condition:
High-Grade Glioma
Conditions: Official terms:
Glioma
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
Drug: CLR 131 is a radio-iodinated therapy comprising a core phospholipid ether (PLE)
analogue radiolabeled with iodine-131. CLR 131 exploits the tumor-targeting properties of
PLEs to provide targeted delivery of radiation to malignant tumor cells and minimizes
radiation exposure to normal tissues.
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
CLR 131
Description:
CLR 131 will be administered IV (intravenously) at a dose based on patients' BSA
Arm group label:
Pediatric High-Grade Glioma Patients
Other name:
iopofosine I 131
Summary:
The purpose of this dose finding study is to evaluate the safety and efficacy of 2
different dose levels of CLR 131 in children, adolescents and young adults with relapsed
or refractory high-grade glioma (HGG).
Detailed description:
This study is designed to further evaluate the safety and tolerability of CLR 131 at the
selected doses in children, adolescents and young adults with relapsed or refractory
malignant high-grade glioma. It will also determine the therapeutic activity defined as
progression free survival and overall survival, antitumor activity (treatment response)
defined as the reduction in tumor volume and identify the recommended Phase 2/3 dose of
CLR 131 in children, adolescents and young adults with relapsed or refractory HGG.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Previously confirmed (histologically or cytologically) high grade glioma that is
clinically or radiographically suspected to be relapsed, refractory, or recurrent
- ≥ 10 years of age and ≤ 25 years of age at time of consent/assent
- If ≥ age 16 years, Karnofsky performance status of ≥ 60. If < age 16 years, Lansky
performance status ≥ 60
- Platelets ≥ 75,000/μL (last transfusion, if any, must be at least 1 week prior to
study registration, and, unless deemed medically necessary, no transfusions are
allowed between registration and dosing)
- Absolute neutrophil count ≥ 750/μL
- Hemoglobin ≥ 8 g/dL (last transfusion must be at least 1 week prior to study
registration, and, unless deemed medically necessary, no transfusions are allowed
between registration and dosing)
- Using the bedside Schwartz formula, estimated GFR (creatinine clearance) > 60
ml/min/1.73m2
- Alanine aminotransferase < 3 × ULN
- Bilirubin < 2 × ULN
- At least 1 measurable intracranial lesion with longest diameter of at least 10 mm on
any imaging sequence.
- Patients with previously known neurological deficits must be clinically stable at
time of enrollment and able to complete all study related procedures. Patients with
documented or newly diagnosed neurological deficits will be enrolled at the
investigator's discretion.
- If patient receives steroids for neurological symptom control, the dose must be
stable (unchanged for three weeks prior to registration) or on a steroid tapering
regimen. Initiation of steroids per routine care immediately prior to CLR 131 dosing
is acceptable
- Patient or his or her legal representative is judged by the Investigator to have the
initiative and means to be compliant with the protocol.
- Patient or his or her legal representative has the ability to read, understand, and
provide written informed consent for the initiation of any study-related procedures.
- Female patients of childbearing potential must have a negative pregnancy test at
screening and within 24 hours of dosing. It is recommended that female caregivers of
childbearing potential have a negative pregnancy test within one week of dosing.
- Patients of childbearing potential must practice an effective method of birth
control while participating on this study to avoid possible harm to the fetus.
Exclusion Criteria:
- Antitumor therapy or investigational therapy, within 3-half-lives of the agent
preceding the present study. For certain types of radiation (craniospinal, total
abdominal, whole lung [spot irradiation to skull-based metastases is not considered
craniospinal radiation for the purposes of this study]), at least 3 months must have
elapsed. Palliative focal radiation to non-target lesions should be completed at
least 2 weeks prior to dosing. Patients participating in non-interventional clinical
trials (i.e., non-drug) are allowed to participate in this trial
- History of hypersensitivity to thyroid protection medication (e.g., potassium
iodide, Lugol's solution, etc.)
- Any other concomitant serious illness or organ system dysfunction (including cardiac
and pulmonary dysfunction) that in the opinion of the Investigator would either
compromise patient safety or interfere with the evaluation of the safety of the test
drug.
- Major surgery within 6 weeks of enrollment unless delay in therapy poses
unacceptable risk to the patient due to clinical progression (enrollment o such
patients should be discussed with Medical Monitor)
- Known history of human immunodeficiency virus or uncontrolled, serious, active
infection
- Pregnancy or breast-feeding
Gender:
All
Minimum age:
10 Years
Maximum age:
25 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Stanford University
Address:
City:
Palo Alto
Zip:
94304
Country:
United States
Status:
Recruiting
Contact:
Last name:
Allison Pribnow, MD
Facility:
Name:
Memorial Sloan Kettering Cancer Center
Address:
City:
New York
Zip:
10065
Country:
United States
Status:
Recruiting
Contact:
Last name:
Julia Glade-Blender, MD
Facility:
Name:
Cincinnati Children's Hospital Medical Center
Address:
City:
Cincinnati
Zip:
45229
Country:
United States
Status:
Recruiting
Contact:
Last name:
Scott Raskin, DO
Facility:
Name:
Children's Hospital of Philadelphia
Address:
City:
Philadelphia
Zip:
19104
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Cassie Kline, MD
Facility:
Name:
UT Southwestern Medical Center
Address:
City:
Dallas
Zip:
75390
Country:
United States
Status:
Recruiting
Contact:
Last name:
Ashley Bui, MD
Facility:
Name:
Texas Children's Cancer Center, Baylor College of Medicine
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jennifer Foster, MD
Facility:
Name:
University of Wisconsin, Carbone Cancer Center
Address:
City:
Madison
Zip:
53705
Country:
United States
Status:
Recruiting
Contact:
Last name:
Nicolas Pytel, MD
Facility:
Name:
Hospital for Sick Children
Address:
City:
Toronto
Zip:
M5G 1X8
Country:
Canada
Status:
Recruiting
Contact:
Last name:
Daniel Morgenstern, MD
Start date:
October 1, 2023
Completion date:
September 2026
Lead sponsor:
Agency:
Cellectar Biosciences, Inc.
Agency class:
Industry
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
Cellectar Biosciences, Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05610891
