Clinical trial NCT03587038: OKN-007 in Combination With Adjuvant Temozolomide Chemoradiotherapy for Newly Diagnosed Glioblastoma
Official title: Feasibility Pilot Study of OKN-007 in Combination With Adjuvant Temozolomide Chemoradiotherapy in Patients With Newly Diagnosed Glioblastoma
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Glioblastoma
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
First posted: 2018-07-16
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a pilot study exploring the potential benefit of adding OKN-007 with Temozolomide for treatment in patients with malignant Glioblastoma undergoing adjuvant concomitant radiotherapy. This drug combination is expected to have an anti-cancer effect in patients who have experienced disease progression after first line treatment.


Eligibility criteria: Inclusion Criteria:

* Patients have newly diagnosed histologically proven WHO grade III or grade IV Glioblastoma Multiforme (GBM).
* Patients at initial presentation of GBM must undergo an adequate surgical resection of the primary lesion; patients must be registered within 49 days (7 weeks) of the surgery.
* Patients must have available and be willing to submit a minimum of five unstained slides tumor tissue specimens from the GBM surgery or open biopsy for MGMT status analysis and molecular profile analysis.
* ECOG performance status within 0 - 2
* Full recovery (\< grade 1) from the adverse events associated with prior surgery or 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; AST / ALT (SGPT) \<2.5 x ULN; Total bilirubin ≤ 1.5 x institutional upper limit of normal (IULN) (except Gilbert's Syndrome, who must have a total bilirubin \< 3.0 mg/dL); Creatinine within normal limits
* Patients must be ≥ 18 years of age
* Patients must be willing to have blood draws for PK analysis
* All patients must have a CT or MRI of the brain within 14 days prior to registration. The brain CT or MRI should be performed with intravenous contrast (unless contraindicated).
* Patients must be informed of the investigational nature of this study and must sign and give written informed consent for this protocol in accordance with institutional and federal guidelines.
* Life expectancy ≥ 3 months, allowing adequate follow up of toxicity evaluation and progression-free survival evaluation;
* Female patient, if of childbearing potential, has a negative serum pregnancy test within 72 hours of taking study medication and agrees to abstain from activities that could result in pregnancy from enrollment through 120 days after the last dose of study treatment
* Male patient agrees to use an adequate method of contraception
* Birth control should be used from the signing of the patient consent form and for 120 days following the last dose of study treatment.
* In addition, men must not donate sperm during study therapy and for 120 days after receiving the last dose of study treatment.

Exclusion Criteria:

* 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.
* Screening ECG abnormality documented by the investigator as medically significant
* Inability to comply with protocol or study procedures.
* Women who are pregnant or breastfeeding.

Primary outcomes:
measure: The maximum tolerated dose and the type of dose limiting toxicities
timeFrame: 5 years
Secondary outcomes:
measure: Number of participants who experience progression-free survival
timeFrame: 5 years
measure: Number of participants who comply with study treatment plan
timeFrame: 5 years
measure: Number of participants who are able to receive a reduction in steroid dose
timeFrame: 5 years
measure: Number of participants who experience overall survival
timeFrame: 5 years
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: Stephenson Cancer Center, University of Oklahoma Health Sciences Center
state: Oklahoma
Study officials:
affiliation: Principal Investigator
name: James Battiste, MD
role: PRINCIPAL_INVESTIGATOR
References: