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Imaging Trial With I-124-CLR1404 in Patients With Newly Diagnosed or Recurrent Glioblastoma

Study Purpose

The primary objective of this trial is to determine the optimal dose and imaging time point(s) of I-124-CLR1404 in subjects with newly diagnosed and recurrent glioma to be used in future trials.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - newly diagnosed glioblastoma or recurrent/suspected recurrent glioblastoma.
  • - scheduled to undergo a clinically-indicated surgery or biopsy (specific cohorts) - ECOG performance status of 0 to 2 (Appendix C) - 18 years of age or older.
  • - has the initiative and means to be compliant with the protocol and be within geographical proximity to make the required study visits.
  • - has the ability to read, understand and provide written informed consent for the initiation of any study related procedures (or legal representative) - if female of childbearing potential must have a negative pregnancy test within 24 hours of enrollment.
  • - Women of childbearing potential and men who are able to father a child, must agree to use an effective method of contraception (e.g., oral contraceptives, double-barrier methods such as a condom and a diaphragm, intrauterine device, Norplant, Depo-Provera) during the study and for 45 days following the last dose of the study drug.

Exclusion Criteria:

  • - ongoing grade 2 or greater toxicities due to previous therapies.
However, tolerable grade 2 adverse (e.g. neuropathy) events may be allowed at the discretion of the investigator.
  • - has following laboratory abnormalities.
  • - Platelets < 100,000/μL.
  • - WBC < 3000/μL.
  • - Hematocrit < 22% - Serum creatinine > 2.5 mg/dL.
  • - ALT > 1.5 x ULN.
  • - Bilirubin > 1.5 x ULN.
  • - ongoing chronic immunosuppressive therapy.
  • - history of hypersensitivity to iodine.
  • - any other concomitant serious illness or organ system dysfunction which in the opinion of the investigator would either compromise subject safety or interfere with the evaluation of the safety of the test drug.
  • - women of childbearing potential, or men who are able to father a child, unwilling to use a medically acceptable method of contraception during the trial.
  • - pregnancy or breast-feeding.
  • - inability to comply with the protocol.
- use of any investigational drug within 4 weeks of dosing (unless a longer time period is required by local regulations or the investigational agent)

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT01898273
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Cellectar Biosciences, Inc.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 John Kuo, MD, PhDJana Portnow, MDAbass Alavi, MD
Principal Investigator Affiliation University of Wisconsin, MadisonCity of Hope Medical CenterUniversity of Pennsylvania
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Industry
Overall Status Terminated
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Glioblastoma
Arms & Interventions

Arms

Experimental: Single

I-124-CLR1404, open-label

Interventions

Drug: - I-124-CLR1404

single-dose, intravenous

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

City of Hope, Duarte, California

Status

Address

City of Hope

Duarte, California, 91010

Tampa, Florida

Status

Address

Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612

Baltimore, Maryland

Status

Address

University of Maryland School of Medicine

Baltimore, Maryland, 21201

Cleveland Clinic, Cleveland, Ohio

Status

Address

Cleveland Clinic

Cleveland, Ohio, 44195

Ohio State University Medical Center, Columbus, Ohio

Status

Address

Ohio State University Medical Center

Columbus, Ohio, 43210

Kettering Medical Center, Kettering, Ohio

Status

Address

Kettering Medical Center

Kettering, Ohio, 45429

Hospital of University of Pennsylvania, Philadelphia, Pennsylvania

Status

Address

Hospital of University of Pennsylvania

Philadelphia, Pennsylvania, 19104

University of Wisconsin, Madison, Wisconsin

Status

Address

University of Wisconsin

Madison, Wisconsin, 53792

Medical College of Wisconsin, Milwaukee, Wisconsin

Status

Address

Medical College of Wisconsin

Milwaukee, Wisconsin, 53228

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