A Phase II Trial of Talampanel in Patients With Recurrent High-Grade Gliomas.
1. Patients with histologically proven intracranial malignant glioma will be eligible
for this protocol. Malignant glioma include glioblastoma multiforme (GBM),
anaplastic astrocytoma (AA), anaplastic oligodendroglioma (AO), anaplastic mixed
oligoastrocytoma (AMO), or malignant astrocytoma NOS (not otherwise specified).
2. Patients must have unequivocal evidence for tumor progression by MRI or CT scan.
This scan should be performed within 14 days prior to registration and on a steroid
dosage that has been stable for at least 5 days.
3. Patients having undergone recent resection of recurrent or progressive tumor will be
eligible as long as all of the following conditions apply:
1. They have recovered from the effects of surgery.
2. Residual disease following resection of recurrent tumor is not mandated for
eligibility into the study. To best assess the extent of residual disease
post-operatively, a CT/ MRI should be done:
- no later than 96 hours in the immediate post-operative period or
- at least 4 weeks post-operatively, and
- within 14 days of registration, and
- on a steroid dosage that has been stable for at least 5 days.
4. If the 96-hour scan is more than 21 days before registration, the scan needs to be
5. Patients must have failed prior radiation therapy and must have an interval of
greater than or equal to 4 weeks from the completion of radiation therapy to study
6. All patients must sign an informed consent indicating that they are aware of the
investigational nature of this study.
7. Patients must be > 18 years old, and with a life expectancy > 8 weeks.
8. Patients must have a Karnofsky performance status of > 60.
9. Patients must have recovered from the toxic effects of prior therapy: 4 weeks from
any investigational agent, 4 weeks from prior cytotoxic therapy, two weeks from
vincristine, 6 weeks from nitrosoureas, 3 weeks from procarbazine administration, and
1 week for non-cytotoxic agents, e.g., interferon, tamoxifen, thalidomide,
cis-retinoic acid, etc. (radiosensitizer does not count).
10. Patients must have adequate bone marrow function (ANC > 1,200/mm3, platelet count of
> 100,000/mm3, and hemoglobin > 10 gm/dl), adequate liver function (SGOT and
bilirubin < 2 times ULN), and adequate renal function (serum creatinine < 1.5 mg/dL
otherwise a measured 24-hour creatinine clearance > 60 cc/min) before starting
therapy. These tests must be performed within 14 days prior to registration.
11. Patients must not have any significant medical illnesses that in the investigator's
opinion cannot be adequately controlled with appropriate therapy or would compromise
the patients' ability to tolerate this therapy.
12. This study was designed to include women and minorities, but was not designed to
measure differences of intervention effects.
13. Patients must not have active infection requiring IV antibiotics.
14. Patients must not be pregnant or nursing, and all patients (both men and women) must
be willing to practice birth control during and for 2 months after treatment with
Talampanel. Women of childbearing potential (WCBP) must have a negative serum or
urine pregnancy test. In addition, sexually active WCBP must agree to use adequate
contraceptive methods (oral, injectable, or implantable hormonal contraceptive; tubal
ligation; intra-uterine device; barrier contraceptive with spermicide; or
1. Patients who, in the view of the treating physician, have significant active cardiac,
hepatic, renal, or psychiatric diseases are ineligible that would significantly
increase the risk of using talampanel.
2. No concurrent use of other standard chemotherapeutics or investigative agents.
3. Patients known to have an active, life-threatening malignancy.