Clinical trial NCT01672463: Clinical Trial of IV OKN-007 in a Pilot Cohort of Human Recurrent Malignant Glioma Patients
Official title: Phase 1b Clinical Trial of IV OKN-007 in a Pilot Cohort of Human Recurrent Malignant Glioma Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Recurrent Malignant Glioma
Lead sponsor: Oblato, Inc.
Sponsor class: INDUSTRY
First posted: 2012-08-24
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Number of Adverse events per patient
timeFrame: 24 months
Secondary outcomes:
measure: PK level in participants
timeFrame: 24 months
measure: 6 month progression-free survival
timeFrame: 24 months
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: Oklahoma University
state: Oklahoma
Study officials:
affiliation: • Oklahoma University
name: James Battiste, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: