What side effects are associated with this type of intervention?

Treatments for malignant glioma that involve multi-pathway cancer cell signaling inhibition and blood-brain barrier penetration, such as targeted therapies and tyrosine kinase inhibitors, commonly cause side effects like fatigue, nausea, vomiting, headache, and skin reactions. More severe side effects can include hematologic toxicities, liver enzyme abnormalities, and gastrointestinal issues. The specific side effects can vary based on the treatment regimen and the patient's health status.

What prior FDA approvals exist?

The FDA has approved several treatments for Malignant Glioma, including temozolomide, which is an oral alkylating agent that can cross the blood-brain barrier and is often used in combination with radiotherapy. Bevacizumab, an anti-VEGF monoclonal antibody, has also been approved for recurrent glioblastoma due to its ability to inhibit angiogenesis. While these treatments do not target multiple signaling pathways as broadly as fb-PMT, they represent significant advancements in the management of Malignant Glioma. Other investigational treatments, such as buparlisib, have been studied for their potential to inhibit multiple pathways, but have not yet achieved FDA approval due to safety and efficacy concerns.

What other types of research exist?

Promising novel alternatives to fb-PMT for malignant glioma patients include: 1) T-DM1 (ado-trastuzumab emtansine), which has shown efficacy in brain metastases from HER2-positive cancers and can cross the blood-brain barrier. 2) Osimertinib, an EGFR TKI, which has demonstrated significant CNS efficacy in non-small cell lung cancer with brain metastases. 3) Capmatinib, a MET inhibitor, which has shown activity in METex14-mutated advanced non-small cell lung cancer with brain metastases. These therapies are being investigated for their potential application in gliomas due to their ability to target multiple pathways and penetrate the blood-brain barrier.

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fb-PMT for Glioblastoma

Phase 1

Recruiting

Led By Nicholas Blondin, MD

Research Sponsored by NanoPharmaceuticals LLC

Eligibility Criteria Checklist

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

Must have

Histologically proven intracranial glioblastoma, with first or second recurrence

Hypertension must be well controlled (≤ 95th percentile) on stable doses of medication

Must not have

A significant vascular disease (e.g., aortic aneurysm requiring surgical repair, deep venous or arterial thrombosis) within the last 6 months prior to study enrollment

History of any other cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix), unless in complete remission and off all therapy for that disease for at least 3 months prior to first dose of study drug

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 15 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing fb-PMT, a new drug that targets many signals cancer cells use to grow, on patients with recurrent Glioblastoma. The drug can enter the brain and disrupt cancer cell communication, potentially stopping their growth.

Who is the study for?

This trial is for adults with recurrent glioblastoma, a type of brain tumor. Participants must have had prior treatment, be on stable steroids if used, and have good performance status. They should not be pregnant or breastfeeding, have serious heart conditions or bleeding disorders, nor can they take certain medications that affect the heart rhythm.

What is being tested?

The study tests fb-PMT's safety and tolerability to determine the appropriate dose for treating recurrent glioblastoma. It involves daily subcutaneous injections by patients or caregivers who must also maintain a treatment diary.

What are the potential side effects?

Potential side effects of fb-PMT are not detailed in this summary but may include typical drug-related reactions such as injection site discomfort, allergic reactions, systemic side effects affecting organs due to its broad action on cancer cell signaling pathways.

Eligibility Criteria

Inclusion Criteria

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

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My brain cancer has returned for the first or second time.

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My high blood pressure is under control with stable medication.

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I am mostly able to care for myself but may not be able to do active work.

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I can store medicine in a fridge, give daily shots, and keep a treatment diary.

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I have completed and recovered from standard treatments for glioblastoma, including surgery and radiotherapy.

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My recent tests show my organs and bone marrow are working well.

Exclusion Criteria

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

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I haven't had major blood vessel problems like aneurysms or clots in the last 6 months.

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I have been cancer-free and off treatment for any other cancer than non-melanoma skin cancer or cervical carcinoma in-situ for at least 3 months.

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I do not have any serious infections or illnesses right now.

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I have a serious or non-healing wound, ulcer, or bone fracture.

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I am not taking any medications that affect my heart's rhythm.

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I have a history of or risk factors for a specific heart rhythm problem.

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I haven't taken drugs that affect liver transport proteins in the last 14 days or longer.

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I have previously been treated with fb-PMT or similar drugs.

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I had surgery within the last 28 days and the wound has not fully healed.

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My heart condition is not severe.

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I do not have a bleeding disorder or a history of bleeding problems in the last 28 days.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 15 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~15 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 15 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

Incidence of Dose Limiting Toxicities [Safety and Tolerability]

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

Secondary study objectives

Establishment of Recommended Phase 2 Dose

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: Treatment (fb-PMT)Experimental Treatment1 Intervention

Daily subcutaneous injection of fb-PMT in four escalating cohorts to determine maximum tolerated dose, followed by treatment of up to 10 additional patients at maximum tolerated dose.

0 / 17Eligibility 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

Malignant Glioma treatments often target multiple cancer cell signaling pathways to inhibit tumor growth and progression. Agents like temozolomide, a standard chemotherapy drug, work by damaging the DNA of cancer cells, leading to cell death. Newer treatments, such as targeted therapies and investigational drugs like fb-PMT, aim to inhibit various signaling pathways simultaneously, which can be more effective against the heterogeneous nature of glioma cells. Additionally, the ability of these drugs to penetrate the blood-brain barrier is critical, as it ensures that therapeutic concentrations reach the tumor site within the brain. This multi-faceted approach is essential for improving outcomes in Malignant Glioma patients, given the tumor's resistance to conventional therapies and its location within the central nervous system.