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

Phase 2, Open-Label, Imaging Trial of I-124-CLR1404 in Patients With Newly Diagnosed or Recurrent Glioblastoma

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.

Study Overview

• Status: Terminated
• Conditions: Glioblastoma
• Intervention / Treatment: Drug: I-124-CLR1404

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Duarte, California, United States, 91010
      • City of Hope
  • Florida
    • Tampa, Florida, United States, 33612
      • Moffitt Cancer Center and Research Institute
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland School of Medicine
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
    • Columbus, Ohio, United States, 43210
      • Ohio State University Medical Center
    • Kettering, Ohio, United States, 45429
      • Kettering Medical Center
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Hospital of University of Pennsylvania
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • University of Wisconsin
    • Milwaukee, Wisconsin, United States, 53228
      • Medical College of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single; I-124-CLR1404, open-label	Drug: I-124-CLR1404; single-dose, intravenous; Other Names: I-124-NM404

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Optimal Imaging Parameters - Dose	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.	8 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Optimal Imaging Parameters - Imaging Time Point	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.	8 days

Collaborators and Investigators

• Sponsor: Cellectar Biosciences, Inc.
• Investigators: Principal Investigator: John Kuo, MD, PhD, University of Wisconsin, Madison

Study record dates

Study Major Dates

• Study Start: February 1, 2014
• Primary Completion (Anticipated): September 1, 2015
• Study Completion (Anticipated): December 1, 2015

Study Registration Dates

• First Submitted: July 8, 2013
• First Submitted That Met QC Criteria: July 10, 2013
• First Posted (Estimate): July 12, 2013

Study Record Updates

• Last Update Posted (Estimate): September 9, 2015
• Last Update Submitted That Met QC Criteria: September 8, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Keywords: Imaging; Glioma; PET; Glioblastoma Multiforme; Diagnostic; Radiopharmaceutical
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Glioblastoma
• Other Study ID Numbers: DCL-13-002