27 Participants Needed

OKN-007 + Temozolomide for Glioblastoma

JB
IB
Overseen ByIngrid Block, MD
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: University of Oklahoma
Stay on Your Current MedsYou can continue your current medications while participating
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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

JB

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

I had surgery to remove my brain tumor within the last 7 weeks.
Birth control should be used from the signing of the patient consent form and for 120 days following the last dose of study treatment
I can take care of myself and am up and about more than half of my waking hours.
See 11 more

Exclusion Criteria

Screening ECG abnormality documented by the investigator as medically significant
Inability to comply with protocol or study procedures
I have no other cancers except for treated skin cancer.
See 6 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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.

6 weeks

Follow-up

Participants are monitored for safety, effectiveness, and progression-free survival after treatment

5 years

Treatment Details

Interventions

  • OKN-007
  • Photon/Proton IMRT
  • Temozolomide
Trial Overview The study tests OKN-007 combined with Temozolomide chemotherapy alongside standard radiotherapy in patients with Glioblastoma to see if it improves outcomes after initial treatment failure.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: OKN-007 5 days per week and temozolomideExperimental Treatment3 Interventions
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
Group II: OKN-007 3 days per week plus temozolomideExperimental Treatment3 Interventions
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

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Oklahoma

Lead Sponsor

Trials
484
Recruited
95,900+

Findings from Research

In a phase II trial involving 46 patients with progressive low-grade glioma, Temozolomide (Temodar) demonstrated a 61% objective response rate, with 24% achieving complete response and 37% achieving partial response.
The treatment showed promising safety, with limited toxicity observed; however, one patient experienced severe complications, highlighting the need for careful monitoring during treatment.
Phase II trial of temozolomide in patients with progressive low-grade glioma.Quinn, JA., Reardon, DA., Friedman, AH., et al.[2022]
Temozolomide is primarily used for treating refractory central nervous system cancers like anaplastic astrocytoma and glioblastoma, but ongoing clinical trials are exploring its efficacy and safety in newly diagnosed gliomas and other types of tumors.
Research is also investigating different dosing schedules and combinations with other treatments, suggesting that temozolomide could be a versatile option in cancer therapy beyond its current approved uses.
Future directions for temozolomide therapy.Yung, WK.[2019]
Carmustine wafers (Gliadel) and temozolomide (Temodal) have been approved for treating glioblastoma, with temozolomide showing a median survival benefit of 2 months when used with radiotherapy, and a two-year survival rate of 26.5% compared to 10.4% with radiotherapy alone.
In patients who undergo complete tumor resection, the two-year survival rate can reach 38%, highlighting the potential effectiveness of these treatments in younger patients with good performance status.
[What type of adjuvant chemotherapy should be proposed for the initial treatment of glioblastoma?].Ducray, F., Honnorat, J.[2018]

References

Phase II trial of temozolomide in patients with progressive low-grade glioma. [2022]
Future directions for temozolomide therapy. [2019]
[What type of adjuvant chemotherapy should be proposed for the initial treatment of glioblastoma?]. [2018]
A phase I dose-escalation study (ISIDE-BT-1) of accelerated IMRT with temozolomide in patients with glioblastoma. [2018]
[Temozolomide: Temodal]. [2018]
Temozolomide-induced aplastic anaemia: Case report and review of the literature. [2022]
Phase I trial of temozolomide (NSC 362856) in patients with advanced cancer. [2018]
Temozolomide-related hematologic toxicity. [2018]
Benefit and outcome of using temozolomide-based chemoradiotherapy followed by temozolomide alone for glioblastoma in clinical practice. [2019]
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