Glioblastoma
Conditions
Keywords
Glioma, Glioblastoma Multiforme, PET, Imaging, Radiopharmaceutical, Diagnostic
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.
Interventions
DRUGI-124-CLR1404
single-dose, intravenous
Sponsors
Cellectar Biosciences, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Optimal Imaging Parameters - Dose | 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
| Measure | Time frame | Description |
|---|---|---|
| Optimal Imaging Parameters - Imaging Time Point | 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. |
Countries
United States
Outcome results
None listed