Ph I Oral Topotecan and Temozolomide for Patients With Malignant Gliomas
|ClinicalTrials.gov Identifier: NCT00610571|
Recruitment Status : Completed
First Posted : February 8, 2008
Last Update Posted : October 25, 2013
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Glioblastoma Gliosarcoma Anaplastic Astrocytoma||Drug: Oral Topotecan and Temodar||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||62 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Trial of Oral Topotecan Plus Temodar in the Treatment of Patients With Malignant Gliomas|
|Study Start Date :||April 2004|
|Primary Completion Date :||September 2009|
|Study Completion Date :||April 2012|
Experimental: Oral Topotecan and Temodar
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
Drug: Oral Topotecan and Temodar
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.
- maximum tolerated dose [ Time Frame: 6 months ]
- Safety & efficacy [ Time Frame: 6 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00610571
|United States, North Carolina|
|Duke University Health System|
|Durham, North Carolina, United States, 27710|
|Principal Investigator:||Katherine B Peters, MD, PhD||Duke University Health System|