OKN-007 + Temozolomide for Recurrent Brain Cancer

Recruiting at 12 trial locations

Overseen By Shinwook Kang

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Oblato, Inc.

Must be taking: Temozolomide

Must not be taking: Bevacizumab

Disqualifiers: Second malignancy, Systemic disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 28-day cycles, up to 24 months

57 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is testing a new drug called OKN-007 combined with a chemotherapy drug, temozolomide, in patients whose brain cancer has returned after standard treatments. OKN-007 may help reduce tumor growth and make the chemotherapy more effective. Temozolomide is effective in treating malignant brain tumors.

Will I have to stop taking my current medications?

The trial protocol does not specify if you must stop taking your current medications, but you cannot have received any chemotherapeutic agents, including temozolomide, within 28 days before starting the study. It's best to discuss your current medications with the trial team.

Is the combination of OKN-007 and Temozolomide safe for humans?

Temozolomide, used in brain cancer treatment, generally has mild to moderate side effects like fatigue, nausea, and low blood cell counts, but severe blood-related issues are rare. Medication errors with Temozolomide can be serious, so careful dosing is important. ^{1 2 3 4 5}

What makes the drug OKN-007 + Temozolomide unique for recurrent brain cancer?

The combination of OKN-007 with Temozolomide is unique because it pairs a novel agent, OKN-007, with Temozolomide, a well-established chemotherapy drug known for its effectiveness in treating various brain tumors. This combination may offer a new approach to targeting recurrent brain cancer, potentially enhancing treatment efficacy compared to using Temozolomide alone. ^{2 6 7 8 9}

What data supports the effectiveness of the drug OKN-007 + Temozolomide for recurrent brain cancer?

Research shows that Temozolomide, a drug used in the treatment, has been effective in treating various types of brain tumors, including anaplastic astrocytoma and oligodendroglial tumors, with high response rates in patients with recurrent conditions. ^{2 6 7 10 11}

Who Is on the Research Team?

Shinwook Kang

Principal Investigator

Oblato, Inc.

Are You a Good Fit for This Trial?

Adults with recurrent glioblastoma who've had standard treatment including surgery, radiation, and chemotherapy. They must have good organ function and performance status (able to carry out daily activities), no severe side effects from previous treatments, no more than two prior GBM therapies excluding bevacizumab as second line, and a confirmed diagnosis based on tissue analysis.

Inclusion Criteria

My scans show clear tumor growth, and I have at least one tumor that can be measured.

My glioblastoma was confirmed and I've had specific treatments but not bevacizumab.

I have recovered from side effects of previous treatments.

Exclusion Criteria

Inability to comply with protocol or study procedures

Serious concomitant systemic disorders

Abnormal sodium, potassium, or creatinine levels ≥ grade 2

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive OKN-007 combined with Temozolomide for recurrent glioblastoma

28-day cycles, up to 24 months

Multiple visits for drug administration and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Open-label extension (optional)

Participants may opt into continuation of treatment long-term

Long-term

What Are the Treatments Tested in This Trial?

Interventions

• OKN-007
• Temozolomide

Trial Overview The trial is testing OKN-007 in combination with Temozolomide for safety, effectiveness, and how the body processes it. Participants must show clear signs of tumor recurrence on MRI but should not have received certain other treatments recently or have serious health issues that could interfere.

How Is the Trial Designed?

Group I: All patients Experimental Treatment 2 Interventions

All patients enrolled in this study

Who Is Running the Clinical Trial?

Oblato, Inc.

Lead Sponsor

Trials

5

Recruited

100+

Published Research Related to This Trial

In a phase II trial involving 38 patients with recurrent oligodendroglial tumors, temozolomide (TMZ) demonstrated a high response rate, with 52.6% of patients showing a complete or partial response, indicating its efficacy as a first-line chemotherapy.

TMZ was generally well tolerated, with hematologic side effects being the most common, and only one patient discontinuing treatment due to toxicity, suggesting a favorable safety profile for chemotherapy-naive patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase II study of first-line chemotherapy with temozolomide in recurrent oligodendroglial tumors: the European Organization for Research and Treatment of Cancer Brain Tumor Group Study 26971. van den Bent, MJ., Taphoorn, MJ., Brandes, AA., 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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Future directions for temozolomide therapy. Yung, WK.[2019]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase II trial of temozolomide in patients with progressive low-grade glioma. Quinn, JA., Reardon, DA., Friedman, AH., et al.[2022]

In a phase II trial involving 32 patients with recurrent oligodendroglial tumors, temozolomide (TMZ) demonstrated a 25% objective response rate, indicating its potential as an effective second-line treatment after PCV chemotherapy.

TMZ was generally well tolerated, with hematological side effects being the most common, and a median time to progression of 8 months for those who responded, suggesting it could be a viable option for patients who do not respond to initial treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Second-line chemotherapy with temozolomide in recurrent oligodendroglioma after PCV (procarbazine, lomustine and vincristine) chemotherapy: EORTC Brain Tumor Group phase II study 26972. van den Bent, MJ., Chinot, O., Boogerd, W., et al.[2020]

Temozolomide (TMZ) chemotherapy shows a 24% objective response rate in patients with recurrent anaplastic oligodendroglioma (AO) and anaplastic oligoastrocytoma (AOA), with a median progression-free survival of 8.0 months based on a study of 72 patients.

TMZ is recommended as a salvage therapy for recurrent AO/AOA, particularly for patients previously treated with other chemotherapy, as it has an acceptable toxicity profile with severe side effects occurring in only 13% of patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Temozolomide salvage chemotherapy for recurrent anaplastic oligodendroglioma and oligo-astrocytoma. Gwak, HS., Yee, GT., Park, CK., et al.[2021]

In a retrospective study of 117 adult patients with recurrent gliomas treated with temozolomide (TMZ) under a compassionate use program, the overall objective response rate was 29%, with 34% achieving disease stabilization, indicating that TMZ is effective in this setting.

The treatment was generally well-tolerated, with mild toxicity; however, thrombocytopenia was the most common serious side effect, occurring in 17% of patients, particularly at higher starting doses, highlighting the importance of monitoring for adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Temozolomide for the treatment of recurrent supratentorial glioma: results of a compassionate use program in Belgium. Everaert, E., Neyns, B., Joosens, E., et al.[2022]

The study confirmed that the generic temozolomide capsules (TOZ039) are bioequivalent to the brand Temodal® capsules, with pharmacokinetic parameters falling within the acceptable range for both 20-mg and 100-mg doses in 29 patients with brain tumors.

The treatment was found to be safe, with no treatment-related severe adverse events or mortality reported, although 82.8% of patients experienced some adverse effects, highlighting the importance of monitoring patient responses during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bioequivalence study of 20-mg and 100-mg temozolomide capsules (TOZ309 and Temodal®) in glioma patients in China. Hu, C., Lin, Q., Liu, C., et al.[2021]

Temozolomide (TMZ) is generally safe with mild to moderate side effects, but this case report highlights a rare instance of severe aplastic anemia (AA) in a 68-year-old female patient following treatment for glioblastoma, indicating a potential serious risk associated with the drug.

The patient's AA was managed successfully with supportive care, including platelet transfusions and growth factor treatment, and her blood counts returned to normal within 38 days, emphasizing the importance of monitoring blood parameters during and after TMZ treatment to detect such rare toxicities early.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Temozolomide-induced aplastic anaemia: Case report and review of the literature. Gilbar, PJ., Pokharel, K., Mangos, HM.[2022]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Phase II study of first-line chemotherapy with temozolomide in recurrent oligodendroglial tumors: the European Organization for Research and Treatment of Cancer Brain Tumor Group Study 26971. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Future directions for temozolomide therapy. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Phase II trial of temozolomide in patients with progressive low-grade glioma. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Second-line chemotherapy with temozolomide in recurrent oligodendroglioma after PCV (procarbazine, lomustine and vincristine) chemotherapy: EORTC Brain Tumor Group phase II study 26972. [2020]

5. Korea (South) pubmed.ncbi.nlm.nih.gov

Temozolomide salvage chemotherapy for recurrent anaplastic oligodendroglioma and oligo-astrocytoma. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Analyzing temozolomide medication errors: potentially fatal. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Temozolomide for the treatment of recurrent supratentorial glioma: results of a compassionate use program in Belgium. [2022]

8. Germany pubmed.ncbi.nlm.nih.gov

Bioequivalence study of 20-mg and 100-mg temozolomide capsules (TOZ309 and Temodal®) in glioma patients in China. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Temozolomide-induced aplastic anaemia: Case report and review of the literature. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Phase I study of temozolomide in combination with thiotepa and carboplatin with autologous hematopoietic cell rescue in patients with malignant brain tumors with minimal residual disease. [2018]

11. England pubmed.ncbi.nlm.nih.gov

Temozolomide: a new oral cytotoxic chemotherapeutic agent with promising activity against primary brain tumours. [2022]