Phase 2 Trial Using Talampanel in Patients With Recurrent High Grade Gliomas

NCT00062504 | Terminated Phase 2

• 1 other identifier: IXR-205-21-189
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

To analyze the effect of Talampanel on progression free survival in patients with recurrent high grade gliomas.

Conditions

Glioblastoma Multiforme; Anaplastic Astrocytoma; Anaplastic Oligodendroglioma; Anaplastic Mixed Oligoastrocytoma

Study Arms (3)

1

EXPERIMENTAL

Valproic: 10mg TID week 1, 25mg TID week 2, 35mg week 3

Drug: Talampanel

2

EXPERIMENTAL

Non-enzyme-inducing anti-epileptic drugs: 25mg TID week 1, 35mg week 2, 50mg week 3

Drug: Talampanel

3

EXPERIMENTAL

Enzyme-inducing anti-epileptic drugs: 35mg TID week 1, 505mg week 2, 75mg week 3

Drug: Talampanel

Interventions

Talampanel DRUG

10mg, 25 mg, 35 mg, 50 mg, 75mg TID for 3 weeks

1; 2; 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• 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.
• Patients having undergone recent resection of recurrent or progressive tumor will be eligible as long as all of the following conditions apply:
• They have recovered from the effects of surgery.
• 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.
• If the 96-hour scan is more than 21 days before registration, the scan needs to be repeated.
• 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 entry.
• All patients must sign an informed consent indicating that they are aware of the investigational nature of this study.
• Patients must be \> 18 years old, and with a life expectancy \> 8 weeks.
• Patients must have a Karnofsky performance status of \> 60.
• 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).

You may not qualify if:

• 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.
• No concurrent use of other standard chemotherapeutics or investigative agents.
• Patients known to have an active, life-threatening malignancy.

Sponsors & Collaborators

• Teva Branded Pharmaceutical Products R&D, Inc.: lead
• National Cancer Institute (NCI): collaborator

MeSH Terms

Conditions

Glioblastoma; Astrocytoma; Oligodendroglioma

Interventions

talampanel

Condition Hierarchy (Ancestors)

Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 6, 2003
• First Posted: June 12, 2003
• Study Start: July 1, 2003
• Primary Completion: January 1, 2006
• Study Completion: April 1, 2006
• Last Updated: May 23, 2011

Record last verified: 2011-05