CLR 131 for Pediatric Cancer

(CLOVER-2 Trial)

Recruiting at 7 trial locations

Overseen By Kate Oliver

Age: < 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Cellectar Biosciences, Inc.

Must not be taking: Antitumor, Investigational

Disqualifiers: CNS metastases, I-131 dose > 54 mCi/kg, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: up to 85 days

30 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing CLR 131, a radioactive medicine designed to target and kill cancer cells. It is aimed at children, adolescents, and young adults whose cancers have returned or do not respond to other treatments. CLR 131 works by delivering radiation directly to the cancer cells, reducing harm to healthy cells.

Will I have to stop taking my current medications?

The trial protocol does not specify if you must stop taking your current medications. However, you cannot have received antitumor or investigational therapy within 2 weeks of dosing, and certain types of radiation require a 3-month gap. Please discuss your specific medications with the trial team.

What makes the drug CLR 131 unique for pediatric cancer treatment?

CLR 131 is unique because it uses a radioactive iodine isotope (I-131) to target and destroy cancer cells, which is a different approach compared to traditional chemotherapy. This method allows for targeted treatment, potentially reducing damage to healthy cells and minimizing side effects. ^{1 2 3 4 5}

Research Team

Jarrod Longcor

Principal Investigator

Cellectar Biosciences

Eligibility Criteria

This trial is for young people aged 2-25 with certain types of cancer (like neuroblastoma, sarcomas) that have come back or didn't respond to treatment. They should be fairly active (able to care for themselves), have decent blood counts and organ function, and not be on other cancer treatments. Those who've had a bone marrow transplant must wait at least 3 months before joining.

Inclusion Criteria

I had a bone marrow transplant within the required time frame.

Patients must meet specific blood count criteria

My kidneys are working well.

Exclusion Criteria

My brain involvement from cancer is stable after treatment.

I have been treated with high doses of iodine-131 for my condition.

I have not recently received any cancer treatment or been part of a drug trial.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive CLR 131 intravenous administration with dose escalation to determine the recommended phase 2 dose

up to 85 days

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of overall survival and event-free survival

1 month to 5 years

Dosimetry Assessment

Assessment of dosimetry via whole body planar imaging

up to 15 days post initial infusion

Treatment Details

Interventions

• CLR 131

Trial Overview The study tests CLR 131 in children and young adults with relapsed or stubborn cancers including brain tumors, lymphomas, and solid tumors like osteosarcoma. It aims to find out if this drug can help when other treatments haven't worked.

Participant Groups

Group I: CLR 131 Experimental Treatment 1 Intervention

CLR 131 intravenous administration

CLR 131 is already approved in United States, European Union for the following indications:

Approved in United States as Iopofosine I-131 for:

• Relapsed or refractory multiple myeloma
• Lymphoplasmacytic lymphoma/Waldenstrom’s macroglobulinemia
• Diffuse large B-cell lymphoma

Approved in European Union as Iopofosine I-131 for:

• Relapsed or refractory multiple myeloma

Who Is Running the Clinical Trial?

Cellectar Biosciences, Inc.

Lead Sponsor

Trials

15

Recruited

1,300+

References

1. United States pubmed.ncbi.nlm.nih.gov

Pulmonary metastases in children and adolescents with well-differentiated thyroid cancer. [2022]

2. Germany pubmed.ncbi.nlm.nih.gov

Guiding the postoperative radioactive iodine-131 therapy for patients with papillary thyroid carcinoma according to the prognostic risk groups: a SEER-based study. [2023]

3. Ireland pubmed.ncbi.nlm.nih.gov

Outpatient administration of radioactive iodine after total thyroidectomy for pediatric thyroid cancer: a report of three cases. [2009]

4. United States pubmed.ncbi.nlm.nih.gov

The Use of 123I in Diagnostic Radioactive Iodine Scans in Children with Differentiated Thyroid Carcinoma. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Early and late adverse effects of radioiodine for pediatric differentiated thyroid cancer. [2017]