OKN-007 + Temozolomide for Glioblastoma
Trial Summary
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.
What data supports the effectiveness of the drug OKN-007 + Temozolomide for Glioblastoma?
Temozolomide, when used with radiotherapy, has been shown to improve survival in glioblastoma patients, with a two-year survival rate of 26.5% compared to 10.4% with radiotherapy alone. It is effective in treating various brain tumors and has been approved for initial management of glioblastoma.12345
Is the combination of OKN-007 and Temozolomide safe for humans?
Temozolomide is generally well tolerated, with common side effects like fatigue, nausea, and vomiting. However, it can cause serious blood-related issues like thrombocytopenia (low platelet count) and, rarely, conditions like aplastic anemia (a condition where the body stops producing enough new blood cells).14678
What makes the OKN-007 + Temozolomide treatment for glioblastoma unique?
The OKN-007 + Temozolomide treatment for glioblastoma is unique because it combines Temozolomide, an oral drug that has shown effectiveness in improving survival when used with radiotherapy, with OKN-007, which may offer additional benefits. This combination is being explored to enhance the effectiveness of treatment for glioblastoma, a type of brain cancer, by potentially improving outcomes beyond what Temozolomide alone can achieve.12459
What is the purpose of this trial?
This trial is testing if adding the drug OKN-007 to the standard treatment with Temozolomide and radiotherapy can help patients with malignant Glioblastoma, especially those whose cancer has gotten worse after initial treatment. Temozolomide has become a cornerstone in the treatment of glioblastoma, often used in combination with radiotherapy.
Research Team
James Battiste, MD
Principal Investigator
Principal Investigator
Eligibility Criteria
Adults with newly diagnosed Glioblastoma who've had surgery can join this trial. They need to provide tumor tissue, have a performance status of 0-2, and good organ function. Men must use contraception and not donate sperm for 120 days post-treatment. Women of childbearing potential must test negative for pregnancy and use birth control.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive OKN-007 and Temozolomide in combination with radiotherapy. OKN-007 is administered 3 or 5 times a week, Temozolomide is taken daily for 42 days, and radiotherapy is given in 30 fractions.
Follow-up
Participants are monitored for safety, effectiveness, and progression-free survival after treatment
Treatment Details
Interventions
- OKN-007
- Photon/Proton IMRT
- Temozolomide
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Oklahoma
Lead Sponsor