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

Glioblastoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01898273
• Other study ID #: DCL-13-002
• Status: Terminated
• Phase: Phase 2
• First received: July 8, 2013
• Last updated: September 8, 2015
• Start date: February 2014
• Est. completion date: December 2015

Study information

• Verified date: September 2015
• Source: Cellectar Biosciences, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: December 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Glioblastoma

Intervention

Drug:
• I-124-CLR1404
single-dose, intravenous

Locations

Country	Name	City	State
United States	University of Maryland School of Medicine	Baltimore	Maryland
United States	Cleveland Clinic	Cleveland	Ohio
United States	Ohio State University Medical Center	Columbus	Ohio
United States	City of Hope	Duarte	California
United States	Kettering Medical Center	Kettering	Ohio
United States	University of Wisconsin	Madison	Wisconsin
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	Hospital of University of Pennsylvania	Philadelphia	Pennsylvania
United States	Moffitt Cancer Center and Research Institute	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Cellectar Biosciences, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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