Clinical Trial of IV OKN-007 in a Pilot Cohort of Human Recurrent Malignant Glioma Patients

NCT01672463 | Unknown Phase 1 DMC

• 1 other identifier: HCI57337
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Recurrent Malignant Glioma

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• PK level in participants

  24 months

• 6 month progression-free survival

  24 months

Study Arms (1)

All patients

EXPERIMENTAL

All participants enrolled in this study

Drug: OKN-007

Interventions

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.

All patients

Eligibility Criteria

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

You may qualify if:

• 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:
• Leukocytes \>3,000/mcL
• Absolute neutrophil count \>1,500/mcL
• Platelets \>100,000/mcL
• Total bilirubin within normal limits
• AST / ALT (SGPT) \<2.5 x ULN
• Creatinine within normal limits
• Patients must be \>\_18 years of age

You may not qualify if:

• Second primary malignancy (except adequately treated basal cell carcinoma of the skin). Patients who had another malignancy in the past, but have been free of active disease for more than 2 years, are eligible
• Have received treatment within the last 28 days with a drug that has not received regulatory approval for any indication at the time of study entry
• Serious concomitant systemic disorders (for example, active infection or abnormal electrocardiogram (ECG) indicative of cardiac disease) that, in the opinion of the investigator, would compromise the safety of the patient and his/her ability to complete the study
• Patients with moderate or severe renal impairment (calculated creatinine clearance of \< 60 mL/min)
• Patients with sodium, potassium, or creatinine serum electrolytes \> grade 2.
• Patients with PT/PTT above the upper limit of normal
• Screening ECG abnormality documented by the investigator as medically significant

Sponsors & Collaborators

• Oblato, Inc.: lead

Study Sites (1)

Oklahoma University

Oklahoma City, Oklahoma, 73104, United States

Location

MeSH Terms

Conditions

Glioma

Interventions

OKN 007

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• James Battiste, MD, PhD

  • Oklahoma University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2012
• First Posted: August 24, 2012
• Study Start: December 1, 2012
• Primary Completion: January 31, 2023
• Study Completion: October 1, 2023
• Last Updated: March 29, 2023

Record last verified: 2023-03

Locations

US (1)