New radioactive drug targets childhood cancers that Won't quit
NCT ID NCT03478462
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage trial tests a radioactive drug called CLR 131 in 30 children and young adults with solid tumors, lymphoma, or brain tumors that have come back or not responded to standard treatments. The main goals are to find a safe dose and see if the drug can shrink tumors. Participants receive the drug through an IV, and doctors monitor for side effects and any signs of cancer control.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- CLR 131 (a radioactive drug that targets cancer cells)
- What this could lead to
- If it works, this could point toward a new treatment option for children with cancers that have not responded to standard therapies.
- What could go wrong
- This is an early Phase 1 trial with only 30 participants, so it is too small to prove effectiveness. The drug is radioactive and may cause side effects like damage to healthy tissues.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Apr 2019
- Expected to finish
-
Feb 2027
An estimate. End dates often move.
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
2 to 25 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: All Patients * Previously confirmed (histologically or cytologically) pediatric solid tumor (e.g., neuroblastoma, sarcoma), lymphoma (including Hodgkin's lymphoma), or malignant brain tumors that are clinically or radiographically suspected to be relapsed, refractory, or recurrent for which there are no standard treatment options with curative potential. Note: patients with diffuse intrinsic pontine glioma (DIPG) may enroll without histological or cytological confirmation. * ≥ 2 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 * Patients who have undergone autologous or allogeneic bone marrow transplant must be at least 3 months from transplant. * Patients enrolling at total dose levels \> 30 millicurie (mCi)/m2 must have availability or ability to collect an autologous hematopoietic stem cell back-up product prior to CLR 131 administration. At minimum, 2 x 10\^6/kg cryopreserved CD34+ cells must be available. * Patient or his or her legal representative is judged by the Investigator to have the initiative and means to be compliant with the protocol. Patients with Pediatric Solid Tumor or Lymphoma * At least 1 measurable lesion with longest diameter of at least 10 mm. Patients with a lesion(s) that are determined to be Metaiodobenzylguanidine (MIBG) or positron emission tomography (PET) positive may be enrolled at the investigator's discretion, even if not associated with a measurable lesion of at least 10 mm. Patients with neuroblastoma who have detectable disease may enroll provided they meet the requirements of the International Neuroblastoma Response Criteria. * Patients with known brain metastases must have completed any radiotherapy or systemic treatments for brain metastases prior to enrollment; by investigator assessment be considered stable with no new signs or symptoms for at least 1 month, and on a stable dose of steroids (unchanged for three weeks prior to registration or on a steroid tapering regimen). Patients with Recurrent or Refractory Brain Tumors * At least 1 measurable 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. Exclusion Criteria: * Patients receiving active treatment for central nervous system metastases or those that are likely to require active treatment during anticipated participation in this trial. Patients with stable brain metastases treated with steroids may enroll at the investigator's discretion * For solid tumor and lymphoma patients only, central nervous system involvement unless previously treated with surgery, systemic therapy, or radiotherapy with the patient neurologically stable. Patients with metastatic brain tumors that have been previously treated are allowed, provided the patient is neurologically stable (determined at the investigator's discretion). * Antitumor therapy or investigational therapy, within 2 weeks of dosing. 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. No washout is required for palliative focal radiation. NOTE: Patients participating in non-interventional clinical trials (i.e., non-drug) are allowed to participate in this trial * Patients previously treated with iodine-131 (131I)-MIBG who have already received a cumulative I-131 dose \> 54 mCi/kg or who would exceed 54 mCi/kg by participating in this trial, are not eligible.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for DIPG are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Children's Hospital at Westmead
Westmead, New South Wales, 2145, Australia
-
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
-
Duke University
Chapel Hill, North Carolina, 27708, United States
-
Hospital for Sick Children
Toronto, Ontario, M5G1X8, Canada
-
Lucile Packard Children's Hospital
Palo Alto, California, 94304, United States
-
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
-
Texas Children's Hospital
Houston, Texas, 77030, United States
-
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53792, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- A pill that blocks RAS: can it help children whose tumors came back?
- A vast data bank could unlock secrets of bone and muscle diseases
- Can an immune booster outsmart High-Risk bone cancer?
- Can a new drug tame ewing sarcoma when others fail?
- Can a drug duo outsmart resistant tumors?
- Can an antibody drug outsmart resistant Ewing's sarcoma?