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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01898273
Recruitment Status : Terminated
First Posted : July 12, 2013
Last Update Posted : September 9, 2015
Information provided by (Responsible Party):
Cellectar Biosciences, Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Glioblastoma Drug: I-124-CLR1404 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Phase 2, Open-Label, Imaging Trial of I-124-CLR1404 in Patients With Newly Diagnosed or Recurrent Glioblastoma
Study Start Date : February 2014
Estimated Primary Completion Date : September 2015
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Single
I-124-CLR1404, open-label
Drug: I-124-CLR1404
single-dose, intravenous
Other Name: I-124-NM404

Primary Outcome Measures :
  1. Optimal Imaging Parameters - Dose [ Time Frame: 8 days ]
    Up to two dose levels (5 mCi and 7.5 mCi) will be evaluated in conjunction with multiple imaging time points to determine the optimal parameters for PET/CT brain imaging. Dosing will begin at 5 mCi and if the images are deemed inadequate, as assessed by count statistics and image quality, the 7.5 mCi dose level will be evaluated.

Secondary Outcome Measures :
  1. Optimal Imaging Parameters - Imaging Time Point [ Time Frame: 8 days ]
    Multiple imaging time points (Day 2, Day 3, and Day 4-8) will be evaluated to determine the optimal parameters for PET/CT brain imaging.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01898273

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United States, California
City of Hope
Duarte, California, United States, 91010
United States, Florida
Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612
United States, Maryland
University of Maryland School of Medicine
Baltimore, Maryland, United States, 21201
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Ohio State University Medical Center
Columbus, Ohio, United States, 43210
Kettering Medical Center
Kettering, Ohio, United States, 45429
United States, Pennsylvania
Hospital of University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, Wisconsin
University of Wisconsin
Madison, Wisconsin, United States, 53792
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53228
Sponsors and Collaborators
Cellectar Biosciences, Inc.
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Principal Investigator: John Kuo, MD, PhD University of Wisconsin, Madison
Principal Investigator: Jana Portnow, MD City of Hope Medical Center
Principal Investigator: Abass Alavi, MD University of Pennsylvania

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Responsible Party: Cellectar Biosciences, Inc. Identifier: NCT01898273     History of Changes
Other Study ID Numbers: DCL-13-002
First Posted: July 12, 2013    Key Record Dates
Last Update Posted: September 9, 2015
Last Verified: September 2015

Keywords provided by Cellectar Biosciences, Inc.:
Glioblastoma Multiforme

Additional relevant MeSH terms:
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Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue