OKN-007 in Combination With Adjuvant Temozolomide Chemoradiotherapy for Newly Diagnosed Glioblastoma

NCT03587038 | Active Not Recruiting Phase 1 DMC FDA Drug

• 2 other identifiers: OU-SCC-Oblato-001OKN-007
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Glioblastoma

Outcome Measures

Primary Outcomes (1)

• The maximum tolerated dose and the type of dose limiting toxicities

  To determine how well patients are able to tolerate combination of OKN-007, temozolomide, and radiotherapy. Adverse events will be tabulated using MedDRA. The severity of the AE will be graded by the Investigator using the NCI CTCAE, version 4.03.

  5 years

Secondary Outcomes (4)

• Number of participants who experience progression-free survival

  5 years

• Number of participants who comply with study treatment plan

  5 years

• Number of participants who are able to receive a reduction in steroid dose

  5 years

• Number of participants who experience overall survival

  5 years

Study Arms (2)

OKN-007 3 days per week plus temozolomide

EXPERIMENTAL

OKN-007: 60 mg/kg, IV, 3 times a week Temozolomide: 75 mg/m2, oral, once daily for 42 days Radiotherapy: 60 Gy administered in 30 fractions

Drug: OKN 007; Drug: Temozolomide; Radiation: Photon/Proton IMRT

OKN-007 5 days per week and temozolomide

EXPERIMENTAL

OKN-007: 60 mg/kg, IV, 5 times a week Temozolomide: 75 mg/m2, oral, once daily for 42 days Radiotherapy: 60 Gy administered in 30 fractions

Drug: OKN 007; Drug: Temozolomide; Radiation: Photon/Proton IMRT

Interventions

OKN 007 DRUG

400 mg OKN-007/mL in a phosphate buffer

OKN-007 3 days per week plus temozolomide; OKN-007 5 days per week and temozolomide

Temozolomide DRUG

75 mg/m2

OKN-007 3 days per week plus temozolomide; OKN-007 5 days per week and temozolomide

Photon/Proton IMRT RADIATION

standard of care treatment to be given 1 to 2 hours after OKN-007

OKN-007 3 days per week plus temozolomide; OKN-007 5 days per week and temozolomide

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

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

Sponsors & Collaborators

• University of Oklahoma: lead

Study Sites (1)

Stephenson Cancer Center, University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73117, United States

Location

MeSH Terms

Conditions

Glioblastoma

Interventions

OKN 007; Temozolomide; Photons

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Elementary Particles; Physical Phenomena; Light; Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Optical Phenomena; Radiation; Radiation, Nonionizing

Study Officials

• James Battiste, MD

  Principal Investigator

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2018
• First Posted: July 16, 2018
• Study Start: September 3, 2018
• Primary Completion: December 23, 2020
• Study Completion (Estimated): November 1, 2026
• Last Updated: December 10, 2025

Record last verified: 2025-12

Locations

US (1)