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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Cellectar Biosciences, Inc.
ClinicalTrials.gov Identifier:
NCT01898273
First received: July 8, 2013
Last updated: September 8, 2015
Last verified: September 2015
  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.

Condition Intervention Phase
Glioblastoma
Drug: I-124-CLR1404
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Cellectar Biosciences, Inc.:

Primary Outcome Measures:
  • 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:
  • 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.


Enrollment: 7
Study Start Date: February 2014
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single
I-124-CLR1404, open-label
Drug: I-124-CLR1404
single-dose, intravenous
Other Name: I-124-NM404

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01898273

Locations
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.
Investigators
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
  More Information

Responsible Party: Cellectar Biosciences, Inc.
ClinicalTrials.gov Identifier: NCT01898273     History of Changes
Other Study ID Numbers: DCL-13-002
Study First Received: July 8, 2013
Last Updated: September 8, 2015

Keywords provided by Cellectar Biosciences, Inc.:
Glioma
Glioblastoma Multiforme
PET
Imaging
Radiopharmaceutical
Diagnostic

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

ClinicalTrials.gov processed this record on April 25, 2017