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

NCT01898273 | Terminated Phase 2 DMC

• 1 other identifier: DCL-13-002
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 9

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.

Conditions

Glioblastoma

Keywords

Glioma; Glioblastoma Multiforme; PET; Imaging; Radiopharmaceutical; Diagnostic

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Optimal Imaging Parameters - Imaging Time Point

  8 days

Study Arms (1)

Single

EXPERIMENTAL

I-124-CLR1404, open-label

Drug: I-124-CLR1404

Interventions

I-124-CLR1404 DRUG

single-dose, intravenous

Also known as: I-124-NM404

Single

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Cellectar Biosciences, Inc.: lead

Study Sites (9)

City of Hope

Duarte, California, 91010, United States

Location

Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States

Location

University of Maryland School of Medicine

Baltimore, Maryland, 21201, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

Kettering Medical Center

Kettering, Ohio, 45429, United States

Location

Hospital of University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

University of Wisconsin

Madison, Wisconsin, 53792, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53228, United States

Location

MeSH Terms

Conditions

Glioblastoma; Glioma; Disease

Condition Hierarchy (Ancestors)

Astrocytoma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2013
• First Posted: July 12, 2013
• Study Start: February 1, 2014
• Primary Completion: September 1, 2015
• Study Completion: December 1, 2015
• Last Updated: September 9, 2015

Record last verified: 2015-09

Locations

US (9)