Neoplasms

All Conditions

Nervous System Diseases

Rare Diseases

Glioma

Glioblastoma

Brain Neoplasms

Astrocytoma

Gliosarcoma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Anaplastic Astrocytoma

Neuroepithelioma

Antineoplastic Agents

All Drugs and Chemicals

Channel Blockers

Anticonvulsants

Analgesics

Central Nervous System Depressants

Psychotropic Drugs

Central Nervous System Stimulants

Temozolomide

Topotecan

Phenytoin

Carbamazepine

Phenobarbital

Oxcarbazepine

Convulsants

Antineoplastic Agents, Alkylating

Alkylating Agents

Topoisomerase I Inhibitors

Enzyme Inhibitors

Two separate strata to accrue independently. Stratum 1: Patients taking receiving Dilantin, Tegretol, Trileptal or Phenobarbital. Stratum 2: Patients on anti-convulsants other than Dilantin, Tegretol, Trileptal or Phenobarbital or patients not on any anti-convulsants

Temozolomide is taken by mouth once day, every day for 5 consecutive days at dose of 200 mg/m2/day.

Oral Topotecan will be taken daily for 5 consecutive days beginning 12-24 hrs after 1st dose of Temozolomide. Dose escalation of Oral Topotecan will be carried out in cohorts of 3 new subjects beginning w dose level 1 @ 0.75 mg/m2/dose.

Oral Topotecan and Temodar

Katherine B Peters, MD, PhD

Objectives:

* To determine the maximum tolerated dose of oral topotecan when administered with Temodar to patients with malignant glioma
* To characterize any toxicity associated with the combination oral topotecan and Temodar.
* To observe patients for clinical antitumor response when treated with oral topotecan and Temodar.

Subjects are patients with glioblastoma (GBM), anaplastic astrocytoma (AA) or grade 3 or greater WHO astrocytic, oligodendroglial or mixed glial tumors, which were initially diagnosed by histologic examination of biopsy/resection. Modified classical "3+3" phase I design used to determine maximum tolerated dose of topotecan in combination with Temodar.

Ph I Oral Topotecan and Temozolomide for Patients With Malignant Gliomas

Phase I Trial of Oral Topotecan Plus Temodar in the Treatment of Patients With Malignant Gliomas

GlaxoSmithKline

Schering-Plough

Katy Peters

Assistant Professor

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Ph I Oral Topotecan and Temozolomide for Patients With Malignant Gliomas	NCT00610571	Glioblastoma Gliosarcoma Anaplastic Astr...	Oral Topotecan ...	18 Years -	Duke University
Ph I Oral Topotecan and Temozolomide for Patients With Malignant Gliomas	NCT00610571	Glioblastoma Gliosarcoma Anaplastic Astr...	Oral Topotecan ...	18 Years -	Duke University

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