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Radioisotope

CLR 131 for Pediatric Cancer (CLOVER-2 Trial)

Phase 1

Waitlist Available

Research Sponsored by Cellectar Biosciences, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must have adequate kidney function

All Patients must have previously confirmed pediatric solid tumor, lymphoma, or malignant brain tumors that are relapsed, refractory, or recurrent with no standard treatment options

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 month to 5 years

Awards & highlights

CLOVER-2 Trial Summary

This trial is testing a new cancer treatment called CLR 131 in children, adolescents, and young adults with cancer that has come back or didn't respond to initial treatment and for which there are no standard treatment options.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Possible side effects aren't specified here but generally may include nausea, fatigue, lowered blood counts leading to increased infection risk, potential kidney or liver issues due to the drug's toxicity profile.

CLOVER-2 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My kidneys are working well.

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

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

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I meet the specific criteria for brain metastases treatment.

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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.

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I am between 2 and 25 years old.

CLOVER-2 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 month to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 month to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 month to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of participants with dose limiting toxicities (DLT)

Secondary outcome measures

Determination of event free survival following CLR 131 infusion in children, adolescents, and young adults

Determination of overall survival following CLR 131 infusion in children, adolescents, and young adults

Determination of preliminary antitumor activity of CLR 131 in children, adolescents, and young adults

+3 more

CLOVER-2 Trial Design

1Treatment groups

Experimental Treatment

Group I: CLR 131Experimental Treatment1 Intervention

CLR 131 intravenous administration

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Cellectar Biosciences, Inc.Lead Sponsor

14 Previous Clinical Trials

1,235 Total Patients Enrolled

1 Trials studying Lymphoma

120 Patients Enrolled for Lymphoma

John Friend, MDStudy DirectorCellectar Biosciences

1 Previous Clinical Trials

120 Total Patients Enrolled

1 Trials studying Lymphoma

120 Patients Enrolled for Lymphoma

Jarrod LongcorStudy DirectorCellectar Biosciences

2 Previous Clinical Trials

170 Total Patients Enrolled

1 Trials studying Lymphoma

120 Patients Enrolled for Lymphoma

Media Library

CLR 131 (Radioisotope) Clinical Trial Eligibility Overview. Trial Name: NCT03478462 — Phase 1

Lymphoma Clinical Trial 2023: CLR 131 Highlights & Side Effects. Trial Name: NCT03478462 — Phase 1

CLR 131 (Radioisotope) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03478462 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA officially sanctioned CLR 131 for therapeutic use?

"Due to the limited evidence of efficacy and safety, CLR 131 was graded a 1 on a scale from 1-3 by our team at Power. This is reflective of its Phase 1 status."

Answered by AI

What is the capacity of this trial in terms of participant numbers?

"In order to commence the trial, 30 qualified participants must be recruited from two separate centres: Cincinnati Children's Hospital Medical Center in Cincinnati, Ohio and Lucile Packard Children's Hospital in Palo Alto, California."

Answered by AI

How widely is the trial being conducted across Canadian hospitals?

"Presently, 6 recruitment sites are accepting applicants for this trial. These include Cincinnati, Palo Alto and Houston with 3 others scattered throughout the continent. If you choose to join the study, it is beneficial to pick a nearby location in order to limit your travel exigencies."

Answered by AI

Have any other experiments utilized CLR 131?

"Presently, 3 trials are investigating the effects of CLR 131. None of these investigations have progressed to Phase 3 research yet; however, 33 different sites across the United States are running studies on this medication with most located in Redlands California."

Answered by AI

Are there any remaining openings for prospective participants in this clinical experiment?

"Affirmative. The clinicaltrials.gov portal verifies that this research endeavour is currently enrolling participants, having first been submitted on April 30th 2019 and most recently modified on November 30 2021. As of now, 30 people are being recruited from 6 sites for the trial."

Answered by AI

Is it possible to become part of this medical research program?

"This clinical trial requires 30 participants, aged 2 to 25 years old and suffering from neuroblastoma. To qualify for the study, patients must have histologically or cytologically confirmed pediatric solid tumors (e.g., neuroblastoma, sarcoma), lymphomas (including Hodgkin's lymphoma) or malignant brain tumours that are clinically or radiographically suspected of relapse/refractory status with no standard treatments possessing curative potential; diffuse intrinsic pontine gliomas need not be verified if present. Additionally, applicants’ Karnofsky Performance Status should be 60+ when 16+, Lansky Performance Status should also exceed"

Answered by AI

Is there an age-limit for inclusion in this research study?

"Following the guidelines, this research requires participants to be at least two years old and no older than 25."

Answered by AI

Is this trial a pioneering endeavor in its field?

"Cellectar Biosciences, Inc. initiated a Phase 2 trial of CLR 131 in 2017 with 120 participants across 6 countries and 24 cities. Since then, two additional studies have been conducted to further explore this compound's efficacy and safety profile."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Dose Escalation Study of CLR 131 in Children, Adolescents, and Young Adults With Relapsed or Refractory Malignant Tumors Including But Not Limited to Neuroblastoma, Rhabdomyosarcoma, Ewings Sarcoma, and Osteosarcoma

2019. "Dose Escalation Study of CLR 131 in Children, Adolescents, and Young Adults With Relapsed or Refractory Malignant Tumors Including But Not Limited to Neuroblastoma, Rhabdomyosarcoma, Ewings Sarcoma, and Osteosarcoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03478462.

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