View a list of resources dedicated to supporting your journey with cancer.
Clinical Trials
Clinical trials (research studies) have shown that treatment with the GLIADEL®
Wafer extended survival in patients with high-grade malignant gliomas and those
with recurrent malignant glioblastoma multiforme.6
A clinical trial demonstrated that GLIADEL increased median survival for patients
diagnosed with high-grade malignant gliomas. Participants were enrolled and randomly
assigned to receive surgery with implantation of GLIADEL followed with radiation
therapy, or surgery with implantation of placebo wafers followed with radiation
therapy. The median survival (the length of time half the patients in the study
survived) increased to 13.8 months from 11.6 months.6 The hazard ratio
for GLIADEL treatment was 0.73 (95% CI: 0.56-0.95).
Another clinical trial demonstrated that patients with recurrent malignant glioblastoma
multiforme (GBM) had increased 6-month survival rates compared to those who received
placebo wafers. 56% (40/72) of patients who received GLIADEL were still alive after
6 months versus 36% (26/73) of patients who had surgery without GLIADEL.6
Access
patient resources
to help you better manage your condition and treatment.
References
Prescribing Information
Important Safety Information
GLIADEL Wafer should not be given to patients who have demonstrated a previous hypersensitivity
to carmustine or any of the components of GLIADEL Wafer.
Patients undergoing craniotomy for malignant glioma and implantation of GLIADEL
Wafer should be monitored closely for known complications of craniotomy, including
seizures, intracranial infections, abnormal wound healing, and brain edema. Cases
of intracerebral mass effect unresponsive to corticosteroids have been described
in patients treated with GLIADEL Wafer, including 1 case leading to brain herniation.
Carmustine, the active component of GLIADELWafer, can cause fetal harm when administered
to a pregnant woman. It is recommended that patients receiving GLIADEL Wafer discontinue
nursing.
Communication between the surgical resection cavity and the ventricular system should
be avoided to prevent the wafers from migrating into the ventricular system and
causing obstructivehydrocephalus. If a communication larger than the diameter of
a wafer exists, it should be closed prior to wafer implantation.
CT and MRI of the head may demonstrate enhancement in the brain tissue surrounding
the resection cavity after implantation of GLIADEL Wafer. This enhancement may represent
edema and inflammation caused by GLIADEL Wafer or tumor progression.
The short-term and long-term toxicity profiles of GLIADEL Wafer when given in conjunction
with chemotherapy have not been fully explored.
The following 4 categories of adverse events are possibly related to treatment with
GLIADEL Wafer:
Seizures: In the initial surgery trial, the incidence of seizures was 33.3%
in patients receiving GLIADEL Wafer and 37.5% in patients receiving placebo. Grand
mal seizures occurred in 5% of GLIADEL Wafer–treated patients and 4.2% of placebo-treated
patients. The incidence of seizures within the first 5 days after wafer implantation
was 2.5% in the GLIADEL Wafer group and 4.2% in the placebo group.
In the surgery for recurrent disease trial, the incidence of post-operative seizures
was 19% in both patients receiving GLIADEL Wafer and placebo. In this study, 12/22
(54%) of patients treated with GLIADEL Wafer and 2/22 (9%) of placebo patients experienced
the first new or worsened seizure within the first 5 post-operative days.
The median time to onset of the first new or worsened post-operative seizure was
3.5 days in patients treated with GLIADEL Wafer and 61 days in placebo patients.
Brain Edema: In the initial surgery trial, brain edema was noted in 22.5%
of patients treated with GLIADEL Wafer and 19.2% of patients treated with placebo.
Development of brain edema with mass effect (due to tumor recurrences, intracranial
infection, or necrosis) may necessitate re-operation and, in some cases, removal
of GLIADEL Wafer or its remnants.
Healing Abnormalities: The following healing abnormalities have been reported
in GLIADEL Wafer clinical trials: wound dehiscence, delayed wound healing, subdural,
subgaleal or wound effusions, and cerebrospinal fluid leak. In the initial surgery
trial, healing abnormalities occurred in 15.8% of GLIADEL Wafer–treated patients
and in 11.7% of placebo recipients. Cerebrospinal fluid leaks occurred in 5% of
GLIADEL Wafer recipients and 0.8% of those given placebo.
During surgery, a water-tight dural closure should be obtained to minimize the risk
of cerebrospinal fluid leak. In the surgery for recurrent disease trial, the incidence
of healing abnormalities was 14% in GLIADEL Wafer–treated patients and 5% in patients
receiving placebo wafers.
Intracranial Infection: In the initial surgery trial, the incidence of brain
abscess or meningitis was 5% in patients treated with GLIADEL Wafer and 6% in patients
receiving placebo. In the recurrent setting, the incidence of brain abscess or meningitis
was 4% in GLIADEL Wafer patients and 1% in patients receiving placebo.
Please see full Prescribing Information.
|
|
|
This Web site contains information relating to various medical conditions and their treatment. Such information is provided for educational purposes only and is not meant to substitute the advice of a physician or other health care professional.
You should not use this information for diagnosing a health problem or disease. Only your doctor can assess the benefits and risks of therapy to determine whether a medication is right for you. You should discuss any questions about you or your loved one’s personal medical needs with your doctor.
The laws, regulatory requirements and medical practices for pharmaceutical products vary from country to country.
The information provided in this Web site is intended for residents of the United States only. The products discussed herein may have different product labeling in different countries.