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

Primary Purpose

Glioblastoma

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
I-124-CLR1404
Sponsored by
Cellectar Biosciences, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Glioblastoma focused on measuring Glioma, Glioblastoma Multiforme, PET, Imaging, Radiopharmaceutical, Diagnostic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • City of Hope
  • Moffitt Cancer Center and Research Institute
  • University of Maryland School of Medicine
  • Cleveland Clinic
  • Ohio State University Medical Center
  • Kettering Medical Center
  • Hospital of University of Pennsylvania
  • University of Wisconsin
  • Medical College of Wisconsin

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single

Arm Description

I-124-CLR1404, open-label

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
July 8, 2013
Last Updated
September 8, 2015
Sponsor
Cellectar Biosciences, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01898273
Brief Title
Imaging Trial With I-124-CLR1404 in Patients With Newly Diagnosed or Recurrent Glioblastoma
Official Title
Phase 2, Open-Label, Imaging Trial of I-124-CLR1404 in Patients With Newly Diagnosed or Recurrent Glioblastoma
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Terminated
Study Start Date
February 2014 (undefined)
Primary Completion Date
September 2015 (Anticipated)
Study Completion Date
December 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cellectar Biosciences, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glioblastoma
Keywords
Glioma, Glioblastoma Multiforme, PET, Imaging, Radiopharmaceutical, Diagnostic

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single
Arm Type
Experimental
Arm Description
I-124-CLR1404, open-label
Intervention Type
Drug
Intervention Name(s)
I-124-CLR1404
Other Intervention Name(s)
I-124-NM404
Intervention Description
single-dose, intravenous
Primary Outcome Measure Information:
Title
Optimal Imaging Parameters - Dose
Description
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.
Time Frame
8 days
Secondary Outcome Measure Information:
Title
Optimal Imaging Parameters - Imaging Time Point
Description
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.
Time Frame
8 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Kuo, MD, PhD
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jana Portnow, MD
Organizational Affiliation
City of Hope Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Abass Alavi, MD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
City of Hope
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
Moffitt Cancer Center and Research Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
University of Maryland School of Medicine
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Ohio State University Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Kettering Medical Center
City
Kettering
State/Province
Ohio
ZIP/Postal Code
45429
Country
United States
Facility Name
Hospital of University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
University of Wisconsin
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53228
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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