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Carmustine Wafers for Brain Tumor

Phase 2

Recruiting

Research Sponsored by Michele Aizenberg, MD

Eligibility Criteria Checklist

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

Must have

Age 18 years or older (Nebraska is 19 years or older)

RPA class I or II

Must not have

The subject has a bleeding diathesis, or must take anticoagulants, or antiplatelet agents including NSAIDs (non-steroidal anti-inflammatory drugs), at the time of scheduled resection that cannot be stopped for surgery

Prior whole brain radiation therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

All Individual Drugs Already Approved

Summary

This trial is testing if adding GLIADEL to the site of a removed tumor, in addition to radiation treatment within six weeks of surgery, is more effective at preventing cancer recurrence than surgery and radiation alone.

Who is the study for?

This trial is for adults with certain types of solid cancer that has spread to the brain, who are planning surgery to remove one or two tumors. They should be in good physical condition (Karnofsky Score ≥ 70), not have had prior treatment on the area, and expect to live at least 3 more months. Pregnant women and those unable or unwilling to follow study rules can't join.

What is being tested?

The study compares adding GLIADEL wafers directly into the site after tumor removal versus just having radiation therapy post-surgery. The goal is to see which method better prevents cancer from returning.

What are the potential side effects?

GLIADEL may cause side effects like wound healing complications, seizures related to brain swelling, infection risk at the implant site, and potential damage to surrounding healthy brain tissue.

Eligibility Criteria

Inclusion Criteria

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

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I am at least 18 years old, or 19 if I live in Nebraska.

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My brain tumor condition is classified as mild or moderate.

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My platelet count is at least 100,000/mm3, transfusions are okay.

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

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I have up to 4 brain tumors from cancer spread, planning surgery for 1-2.

Exclusion Criteria

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

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I cannot stop my blood thinners or NSAIDs for surgery.

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I have had whole brain radiation therapy before.

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My tumor is larger than 4 cm.

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I have a condition like dementia affecting my brain.

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I have been diagnosed with lymphoma, germ cell cancer, small cell lung cancer, or anaplastic thyroid cancer.

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My brain cancer is classified as RPA class III.

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My cancer has spread to the lining of my brain and spinal cord.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 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

Efficacy of GLIADEL compared to Stereotactic Radiosurgery (SRS)

Awards & Highlights

No Placebo-Only Group

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

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: GLIADEL ArmExperimental Treatment1 Intervention

Once the tumor has been removed, GLIADEL wafers will be applied to the resection cavity. The number of wafers used will be determined by the size of the cavity. Enough wafers should be used so that as much of the cavity is covered as possible.

Group II: Standard of Care ArmActive Control1 Intervention

The tumor will be removed surgically. Within 6 weeks after surgery, the resection will be treated with stereotactic radiosurgery (SRS).

0 / 12Eligibility criteria met