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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All patients | Experimental | All participants enrolled in this study |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OKN-007 | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Adverse events per patient | The primary objective is to determine MTD, tolerance, and safety of OKN-007 in patients with recurrent GBM and anaplastic glioma. | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| PK level in participants | To determine drug levels of OKN-007 in blood. | 24 months |
| 6 month progression-free survival | 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. |
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Inclusion Criteria:
Confirmed histopathology of WHO grade III glioma or WHO grade IV GBM at primary diagnosis
Unequivocal radiographic evidence of tumor progression by MRI within 14 days prior to registration
Prior radiotherapy
Prior Temozolomide treatment
Last cytotoxic chemotherapy 28 or more days or biologic therapy treatment 14 or more days before study start (greater than or equal to 42 days if nitrosourea was administered)
Karnofsky performance status greater than or equal to 60%
Full recovery (< grade 1) from the toxic effects of any earlier intervention and a minimum of 28 days from the administration of any investigational agent
Adequate renal, liver and bone marrow function:
Patients must be >_18 years of age
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James Battiste, MD, PhD | • Oklahoma University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oklahoma University | Oklahoma City | Oklahoma | 73104 | United States |
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| ID | Term |
|---|---|
| D005910 | Glioma |
| ID | Term |
|---|---|
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| C552724 | OKN 007 |
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|
| 24 months |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |