Ph I Oral Topotecan and Temozolomide for Patients With Malignant Gliomas
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|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|
|Actual Primary Completion Date :||September 2009|
|Actual 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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 Health|