Clinical trial · Interventional
Talampanel in Treating Patients With Recurrent High-Grade Glioma
A Phase II Trial Of Talampanel In Patients With Recurrent High-Grade Gliomas
NCT00064363CI-TRIAL-00006400completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Drugs used in chemotherapy such as talampanel use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: This phase II trial is studying how well talampanel works in treating patients with recurrent, progressive high-grade glioma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain and Central Nervous System Tumors | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| talampanel | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Progression at 6 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed high-grade glioma, including any of the following:
* Glioblastoma multiforme
* Anaplastic astrocytoma
* Anaplastic oligodendroglioma
* Anaplastic mixed oligoastrocytoma
* Malignant astrocytoma not otherwise specified
* Patients with clinical and radiographic diagnosis of brain stem glioma are also eligible
* Evidence of tumor progression by MRI or CT scan
* Scan must be performed while patient is on a stable steroid dose for at least 5 days
* Must have failed prior radiotherapy
* Residual disease after prior resection of recurrent or progressive tumor is allowed
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* Karnofsky 60-100%
Life expectancy
* More than 8 weeks
Hematopoietic
* Absolute neutrophil count greater than 1,500/mm\^3
* Platelet count at least 100,000/mm\^3 (transfusion independent)
* Hemoglobin at least 10 g/dL (transfusion allowed)
Hepatic
* Bilirubin less than 2 times upper limit of normal (ULN)
* SGOT less than 2 times ULN
* No significant active hepatic disease
Renal
* Creatinine less than 1.5 mg/dL OR
* Creatinine clearance at least 60 mL/min
* No significant active renal disease
Cardiac
* No significant active cardiac disease
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use 2 effective methods of contraception during and for 2 months after study participation
* Able to swallow whole capsules
* No active infection requiring IV antibiotics
* No significant active psychiatric disease that would preclude use of the study drug
* No other significant uncontrolled medical illness that would preclude study participation
* No other active life-threatening malignancy
PRIOR CONCURRENT THERAPY:
Biologic therapy
* At least 1 week since prior interferon or thalidomide
* No concurrent anticancer immunotherapy
Chemotherapy
* At least 2 weeks since prior vincristine
* At least 3 weeks since prior procarbazine
* At least 6 weeks since prior nitrosoureas
* No other concurrent anticancer chemotherapy
Endocrine therapy
* See Disease Characteristics
* At least 1 week since prior tamoxifen
* Concurrent steroids for the control of increased intracranial pressure allowed
Radiotherapy
* See Disease Characteristics
* At least 4 weeks since prior radiotherapy
* No concurrent anticancer radiotherapy
Surgery
* See Disease Characteristics
* Prior recent resection of recurrent or progressive disease allowed
Other
* Recovered from all prior therapy
* At least 1 week since prior noncytotoxic agents (e.g., isotretinoin), except for radiosensitizers
* At least 4 weeks since prior investigational agents
* At least 4 weeks since prior cytotoxic therapy
* No other concurrent investigational agentsReferences
Publications (1)
- RESULTIwamoto FM, Kreisl TN, Kim L, Duic JP, Butman JA, Albert PS, Fine HA. Phase 2 trial of talampanel, a glutamate receptor inhibitor, for adults with recurrent malignant gliomas. Cancer. 2010 Apr 1;116(7):1776-82. doi: 10.1002/cncr.24957. PMID 20143438