What side effects are associated with this type of intervention?

Common treatments for glioblastoma, such as temozolomide, often result in side effects including nausea, vomiting, fatigue, and hematologic toxicities like neutropenia and thrombocytopenia. Patients may also experience alopecia and an increased risk of infections due to immunosuppression. The investigational agent OKN-007, when combined with temozolomide, is being studied for its potential to enhance temozolomide's effects, but its specific side effects are not yet well-documented.

What prior FDA approvals exist?

Temozolomide (TMZ) is an FDA-approved oral chemotherapy drug used for the treatment of glioblastoma, particularly for patients with newly diagnosed glioblastoma in combination with radiotherapy and as maintenance therapy. TMZ works by alkylating/methylating DNA, which damages the DNA and induces tumor cell death. Other related drugs include bevacizumab, an anti-angiogenic agent approved for recurrent glioblastoma, which inhibits the growth of blood vessels that supply the tumor. These treatments aim to improve survival and manage the aggressive nature of glioblastoma.

What other types of research exist?

Promising novel alternatives for glioblastoma treatment in 2024 include: 1) Immune checkpoint inhibitors such as pembrolizumab and nivolumab, which have shown efficacy in various cancers including glioblastoma. 2) CAR-T cell therapy targeting specific glioblastoma antigens. 3) Tumor Treating Fields (TTF), a non-invasive treatment that uses electric fields to disrupt cancer cell division. 4) Oncolytic virotherapy, which uses genetically modified viruses to selectively infect and kill cancer cells. 5) Combination therapies involving PARP inhibitors and temozolomide to enhance DNA damage in cancer cells.

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OKN-007 + Temozolomide for Recurrent Brain Cancer

Phase 2

Waitlist Available

Research Sponsored by Oblato, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients with unequivocal radiographic evidence of tumor progression by MRI for unresected recurrent tumor with at least one measurable lesion

Confirmed Glioblastoma based on histopathology or molecular profile analysis (WHO Grade IV) following primary treatment with TMZ and radiotherapy and at least two cycles of maintenance TMZ as first-line or second-line treatment with another regimen excluding bevacizumab

Must not have

Second primary malignancy expected to require treatment within a 6-month period except adequately treated basal cell carcinoma of the skin

Treatment within the last 28 days with a drug not approved for any indication at study entry

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Specific side effects are not listed here; however, participants will be monitored for any adverse reactions due to the combination of OKN-007 with Temozolomide. Previous experience suggests potential side effects may include fatigue, nausea, blood count changes among others.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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

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I have recovered from side effects of previous treatments.

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I am 18 years old or older.

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My medical records show my cancer's MGMT status or I can provide a tissue sample for testing.

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I can take care of myself and am up and about more than half of my waking hours.

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I have had up to two treatments for glioblastoma, but not bevacizumab.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not expect to need treatment for another cancer within 6 months, except for skin cancer.

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I haven't taken any experimental drugs in the last 28 days.

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I am using or will start using the Optune device for my tumor.

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I have received or will receive bevacizumab for my brain tumor.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidents of Adverse Events during the subjects are taking OKN-007 with Temozolomide

Overall Survival (OS) rate

Secondary study objectives

AUC of OKN-007 in blood plasma

AUC of Temozolomide in blood plasma

Cmax of OKN-007 in blood plasma

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: All patientsExperimental Treatment2 Interventions

All patients enrolled in this study

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Temozolomide (TMZ)

2005

Completed Phase 3

~760

0 / 11Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Temozolomide (TMZ) is an oral alkylating agent that works by adding alkyl groups to the DNA of cancer cells, leading to DNA damage and cell death. This is particularly effective in Glioblastoma due to the high proliferation rate of these tumor cells. OKN-007, when combined with TMZ, is believed to enhance the DNA alkylating and methylating effects of TMZ, potentially increasing its efficacy. This combination aims to improve treatment outcomes by more effectively targeting the tumor cells, which is crucial for Glioblastoma patients given the aggressive nature and poor prognosis associated with this type of brain cancer.