CLR 131 for Pediatric Cancer (CLOVER-2 Trial)

Recruiting in Palo Alto (17 mi)

+7 other locations

Age: < 65

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Cellectar Biosciences, Inc.

No Placebo Group

Approved in 2 jurisdictions

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.

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

My kidneys are working well.

My child's cancer has come back or hasn't responded to treatment and there are no standard treatments left.

My child has a solid tumor or lymphoma with at least one measurable lesion, or meets the criteria for neuroblastoma.

I meet the specific criteria for brain metastases treatment.

I have a brain tumor that has come back or didn't respond to treatment, with at least one tumor that can be measured. I also meet specific requirements for neurological symptoms and steroid use.

I am between 2 and 25 years old.

Exclusion Criteria

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

I am currently being treated for brain metastases or might need treatment soon.

Participant Groups

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.

1Treatment groups

Experimental Treatment

Group I: CLR 131Experimental Treatment1 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: