Details
Description
Inclusion Criteria
Exclusion Criteria
Details
Title Phase 2, Open-Label, Imaging Trial of I-124-CLR1404 in Patients with Newly Diagnosed or Recurrent Glioblastoma
IRB CLTR 1314
CC 14-1483
Hospital Main Campus
Phase Phase 2
Disease Brain, Glioblastoma
Drug I-124-CLR1404
Description
PRIMARY OBJECTIVES- To determine the optimal dose and imaging time point(s) of I-124-CLR1404 in subjects with newly diagnosed and recurrent glioblastoma to be used in future trials.
- To further define the safety profile of I-124-CLR1404
- To evaluate the diagnostic performance of I-124-CLR1404 as compared with contrast-enhanced MRI
Inclusion Criteria
- Subject has newly diagnosed glioblastoma or recurrent/suspected recurrent glioblastoma and is scheduled to undergo a clinically-indicated surgery or biopsy (Non-Dosimetry Subjects only)
- Subject has recurrent/suspected recurrent glioblastoma and is not scheduled to undergo a clinically-indicated surgery or biopsy (Dosimetry Subjects only)
- Subject has an ECOG performance status of 0 to 2 (Appendix C)
- Subject is 18 years of age or older
- Subject is judged by the Investigator to have the initiative and means to be compliant with the protocol and be within geographical proximity to make the required study visits.
- Subject or his or her legal representative has the ability to read, understand and provide written informed consent for the initiation of any study related procedures.
- Female subjects 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
- Subjects with ongoing grade 2 or greater toxicities due to previous therapies (subject to the additional laboratory abnormalities listed below). However, tolerable grade 2 adverse (e.g. neuropathy) events may be allowed at the discretion of the investigator.
- Prior treatment with bevacizumab
- Prior gliadel therapy (non-dosimetry subjects only)
- Prior therapeutic radioactive iodine
- If any of the following laboratory abnormalities are present, the subject should be excluded:
- Platelets < 110,000/μL
- ANC < 1200 cells/μL
- Lymphocytes < 600 cells/μL
- Hematocrit < 32%
- Serum creatinine > 2.5 mg/dL
- ALT > 1.5 x ULN
- Bilirubin > 1.5 x ULN
- Ongoing chronic immunosuppressive therapy with the exception of standard medical therapies used in the management of the subject's underlying cancer (e.g. corticosteroids)
- History of hypersensitivity to iodine
- Presence of MR-incompatible implants
- 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
- Subjects unable to comply with the protocol
- Use of any investigational drug or cytotoxic therapy within 4 weeks of dosing (unless a longer time period is required by local regulations or the investigational agent), with the following exceptions: 2 weeks for vincristine and non-cytotoxic drugs (e.g. cis-retinoic acid), 3 weeks for procarbazine, and 6 weeks for BCNU and CCNU.