Clinical Trial of IV OKN-007 in a Pilot Cohort of Human Recurrent Malignant Glioma Patients
This is an open label Phase 1b clinical trial of IV administration of OKN-007 in a pilot cohort of human recurrent malignant glioma patients. All patients will have been previously treated with the standard-of-care treatment which includes surgical resection, radiation and chemotherapy, and in some cases treatment for recurrent disease with investigational agents or bevacizumab (Avastin). Patients with unequivocal recurrence (first or greater) established by MRI with and without contrast (e.g., Gd-DTPA (Gadolinium-diethylene triamine pentacetic acid) and meeting inclusion and exclusion criteria, will be eligible for OKN-007 treatment on this protocol.
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase 1b Clinical Trial of IV OKN-007 in a Pilot Cohort of Human Recurrent Malignant Glioma Patients|
- Number of Adverse events per patient [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]The primary objective is to determine MTD, tolerance, and safety of OKN-007 in patients with recurrent GBM and anaplastic glioma.
- PK level in participants [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]To determine drug levels of OKN-007 in blood.
- 6 month progression-free survival [ Time Frame: 24 months ] [ Designated as safety issue: No ]To determine radiographic response rate and 6 month Progression-Free Survival (PFS) of patients treated with OKN-007. PFS is defined as the time from first drug treatment until objective tumor progression or death.
|Study Start Date:||December 2012|
|Estimated Study Completion Date:||September 2015|
|Estimated Primary Completion Date:||September 2015 (Final data collection date for primary outcome measure)|
Experimental: All patients
All participants enrolled in this study
Dose escalation/PK cohort: 20 mg/kg, 40 mg/kg or 60 mg/kg OKN-007 via IV infusion, given 3x/week for the first 4 weeks, then 2x/week for the next 4 weeks, then 1x/week thereafter.
Expansion cohort: MTD via IV infusion given 3x/week for the first 4 weeks, then 2x/week for the next 4 weeks, then 1x/week thereafter.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01672463
|Contact: Britney Hallemail@example.com|
|United States, Oklahoma|
|Oklahoma City, Oklahoma, United States, 73104|
|Contact: Kimberly Benjamin, RN 405-271-8778 ext 48876|
|Principal Investigator: Alexandra Ikeguchi, MD|
|United States, Utah|
|Huntsman Cancer Institute||Recruiting|
|Salt Lake City, Utah, United States, 84112|
|Principal Investigator: Randy Jensen, MD|
|Principal Investigator:||Randy Jensen, MD||Huntsman Cancer Institute|