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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Efficacy of GLIADEL compared to Stereotactic Radiosurgery (SRS)

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 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Michele Aizenberg, MDLead Sponsor

University of NebraskaLead Sponsor

539 Previous Clinical Trials

1,144,634 Total Patients Enrolled

Arbor Pharmaceuticals, Inc.Industry Sponsor

14 Previous Clinical Trials

2,019 Total Patients Enrolled

Media Library

Carmustine 7.7Mg Wafer Clinical Trial Eligibility Overview. Trial Name: NCT04222062 — Phase 2

Brain Tumor Research Study Groups: Standard of Care Arm, GLIADEL Arm

Brain Tumor Clinical Trial 2023: Carmustine 7.7Mg Wafer Highlights & Side Effects. Trial Name: NCT04222062 — Phase 2

Carmustine 7.7Mg Wafer 2023 Treatment Timeline for Medical Study. Trial Name: NCT04222062 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What maladies can be alleviated by administering Carmustine 7.7Mg Wafer?

"Carmustine 7.7Mg Wafer is primarily utilized to treat medulloblastomas, but it has also been used in some scenarios of hodgkin disease, brain tumours, and glioblastoma multiforme (GBM)."

Answered by AI

Has the FDA certified Carmustine 7.7Mg Wafer for medical use?

"As this is a Phase 2 trial, the safety of Carmustine 7.7Mg Wafer was rated at 2 because there exists some evidence for its security but no proof that it can provide therapeutic benefits."

Answered by AI

Are there any opportunities to participate in this clinical study at the present time?

"According to the information presented on clinicaltrials.gov, this trial is continuing its recruitment process with a start date of November 6th 2020 and last edit of September 30th 2022."

Answered by AI

What is the size of this medical trial's participant pool?

"Arbor Pharmaceuticals, Inc. is sponsoring the trial and requires 100 participants who meet the inclusion criteria for participation. Test subjects will be recruited from Ohio State University in Columbus, Ohio and University of Nebraska Medical Center in Omaha, Nebraska."

Answered by AI

Are there any other experiments that have been conducted using Carmustine 7.7Mg Wafer?

"The initial study of Carmustine 7.7Mg Wafer was conducted at City of Hope Medical Center in 2000, and 72 subsequent studies have been concluded to date. Currently 24 clinical trials are recruiting new participants, most notably in Columbus Ohio."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study Comparing GLIADEL to Stereotactic Radiosurgery in Metastatic Brain Disease

Michele Aizenberg, MD 2020. "A Study Comparing GLIADEL to Stereotactic Radiosurgery in Metastatic Brain Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04222062.

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