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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by University of Utah
Sponsor:
Information provided by (Responsible Party):
University of Utah
ClinicalTrials.gov Identifier:
NCT01672463
First received: August 21, 2012
Last updated: March 20, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Recurrent Malignant Glioma
Drug: OKN-007
Phase 1

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by University of Utah:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 31
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)
Arms Assigned Interventions
Experimental: All patients
All participants enrolled in this study
Drug: OKN-007

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.


  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Confirmed histopathology of WHO grade III glioma or WHO grade IV GBM at primary diagnosis
  2. Unequivocal radiographic evidence of tumor progression by MRI within 14 days prior to registration
  3. Prior radiotherapy
  4. Prior Temozolomide treatment
  5. 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)
  6. Karnofsky performance status greater than or equal to 60%
  7. 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
  8. 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
  9. Patients must be >_18 years of age

Exclusion Criteria:

  1. 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
  2. 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
  3. 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
  4. Patients with moderate or severe renal impairment (calculated creatinine clearance of < 60 mL/min)
  5. Patients with sodium, potassium, or creatinine serum electrolytes > grade 2.
  6. Patients with PT/PTT above the upper limit of normal
  7. Screening ECG abnormality documented by the investigator as medically significant
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01672463

Contacts
Contact: Britney Hall 801-213-4395 britney.hall@hci.utah.edu

Locations
United States, Oklahoma
Oklahoma University Recruiting
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         
Sponsors and Collaborators
University of Utah
Investigators
Principal Investigator: Randy Jensen, MD Huntsman Cancer Institute
  More Information

No publications provided

Responsible Party: University of Utah
ClinicalTrials.gov Identifier: NCT01672463     History of Changes
Other Study ID Numbers: HCI57337
Study First Received: August 21, 2012
Last Updated: March 20, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue

ClinicalTrials.gov processed this record on September 16, 2014