What side effects are associated with this type of intervention?

Common treatments for glioblastoma, such as whole brain radiation therapy, temozolomide, and plerixafor, have several known side effects. Whole brain radiation therapy can cause acute and subacute radiation encephalopathy, manifesting as headaches, focal neurologic symptoms, nausea, and vomiting. Temozolomide is associated with headaches, thrombocytopenia, and potential reproductive harm. Plerixafor's side effects are less well-documented in this context but may include gastrointestinal disturbances and injection site reactions. These treatments aim to kill tumor cells, stop their growth, and prevent recurrence, respectively.

What prior FDA approvals exist?

Radiation therapy is a standard treatment for glioblastoma, often used in combination with chemotherapy. Temozolomide, an oral chemotherapy drug, is FDA-approved and works by stopping the growth of tumor cells. It is commonly used alongside radiation therapy to enhance treatment efficacy. Plerixafor, primarily approved for mobilizing hematopoietic stem cells, is being investigated for its potential to prevent glioblastoma recurrence when combined with standard treatments like radiation and temozolomide.

What other types of research exist?

Promising novel alternatives for Glioblastoma treatment in 2024 include: 1) GD2-CAR T cell therapy, which targets H3K27M-mutated diffuse midline gliomas, showing potential in targeting specific tumor mutations. 2) ONC201, a selective DRD2 antagonist, which has shown efficacy in recurrent glioblastoma and H3 K27M-mutant diffuse midline gliomas. 3) Bevacizumab combined with irinotecan, which has demonstrated efficacy in recurrent low-grade gliomas and may be applicable to glioblastoma. 4) Vorasidenib, an inhibitor of mutant IDH1 and IDH2, showing promise in recurrent/progressive gliomas. These therapies represent advancements in targeting specific genetic mutations and pathways involved in glioblastoma.

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Chemotherapy

WBRT + Temozolomide + Plerixafor for Brain Cancer

Phase 2

Waitlist Available

Led By Lawrence Recht

Research Sponsored by Lawrence D Recht

Eligibility Criteria Checklist

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

Must have

Patients must have tissue confirmation of high grade (World Health Organization (WHO) grade IV) glioma including but not limited to glioblastoma, gliosarcoma, glioblastoma with oligodendroglial features, glioblastoma with primitive neuroectodermal tumor (PNET) features.

Patient should have surgery (biopsy, partial resection or gross total resection) and no additional anti-cancer therapy except the chemo-radiation as specified in the protocol.

Must not have

Recent history of myocardial infarct (less than 3 months) or history of active angina.

Prior exposure to plerixafor.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a combination of whole brain radiation, standard chemotherapy (temozolomide), and an additional drug (plerixafor) in patients with glioblastoma. The treatment aims to kill tumor cells and prevent them from returning. Plerixafor has shown promising results in combination with radiation therapy for glioblastoma, including an impressive increase in local tumor control.

Who is the study for?

This trial is for patients with high-grade gliomas, including glioblastoma. They must have had surgery but no other cancer treatments and should be in good enough health to understand the study and give consent. Key requirements include normal liver function tests, adequate kidney function, a negative pregnancy test for women of childbearing age, and an agreement to use effective contraception.

What is being tested?

The study is testing if adding Plerixafor to standard treatment (Temozolomide chemo-radiotherapy) along with Whole Brain Radiation Therapy improves outcomes in glioblastoma patients. It's a phase II trial aiming to see how well these combined therapies work at killing tumor cells or stopping their growth.

What are the potential side effects?

Potential side effects may include typical reactions from radiation like skin irritation and fatigue; chemotherapy-related issues such as nausea, low blood counts leading to increased infection risk; and possible effects from Plerixafor like injection site reactions.

Eligibility Criteria

Inclusion Criteria

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

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My cancer is a high-grade glioma, such as glioblastoma.

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I've had surgery for my cancer and haven't received any other cancer treatments except for the specified chemo-radiation.

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I can care for myself but may need occasional help.

Exclusion Criteria

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

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I have not had a heart attack or active chest pain in the last 3 months.

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I have been treated with plerixafor before.

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I have had cancer before, but it was either skin cancer, cervical or bladder cancer in situ, or treated over 3 years ago.

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I have been treated with Avastin.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Proportion of Progression Free Survival Participants (PFS) at Six Months

Secondary study objectives

Median Survival

Patterns of Treatment Failure

Toxicity Associated With Plerixafor/WBRT

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: Whole Brain Radiotherapy + Plerixafor +ChemoradiotherapyExperimental Treatment4 Interventions

After completion maximal safe surgical resection, patients undergo radiation therapy for 42 days, initiating whole brain radiation therapy at day 21 (dose 16 of radiation therapy) and receive temozolomide daily on days 1 to 42. Beginning 7 days before the completion of whole brain radiation therapy, patients receive plerixafor by continuous infusion on days to 1 to 28. Beginning 1 week after completion of plerixafor infusion and 35 days after completion of whole brain radiation therapy, patients receive temozolomide monthly for 6 to 12 courses in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Plerixafor

2011

Completed Phase 3

~710

Temozolomide

2010

Completed Phase 3

~1880

Radiation Therapy

2017

Completed Phase 3

~7250

0 / 7Eligibility 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

Radiation therapy kills glioblastoma cells by damaging their DNA, which is essential for their rapid division. Temozolomide, a chemotherapy drug, stops tumor cell growth by alkylating DNA, leading to cell death. Plerixafor may prevent recurrence by inhibiting the CXCR4 receptor, disrupting the retention of cancer cells in tissues. These mechanisms are crucial for glioblastoma patients as they target the tumor effectively, potentially improving treatment outcomes and managing disease progression.