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

Katy Peters1 site in 1 country62 target enrollmentApril 2004

ConditionsGlioblastoma Gliosarcoma Anaplastic Astrocytoma

InterventionsOral Topotecan and Temodar

DrugsOral Topotecan and Temodar

Overview

Phase: Phase 1
Intervention: Oral Topotecan and Temodar
Conditions: Glioblastoma
Sponsor: Katy Peters
Enrollment: 62
Locations: 1
Primary Endpoint: maximum tolerated dose
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Detailed Description

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.

Registry

clinicaltrials.gov

Start Date

April 2004

End Date

April 2012

Last Updated

12 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Katy Peters

Responsible Party

Sponsor Investigator

Principal Investigator

Katy Peters

Assistant Professor

Duke University

Eligibility Criteria

Inclusion Criteria

•Histology: GBM, AA or grade 3 or greater WHO astrocytic, oligodendroglial or mixed glial tumors which were initially diagnosed by histologic exam of biopsy/resection
•Age: \> or equal to 18 years
•Performance Status: Karnofsky Performance Status \> or equal to 60% at study entry.
•Renal Function: Serum creatinine \< 1.5 mg/dl or creatinine clearance \> 60 ml/dL.
•Hematologic Status: The following baseline studies will be required before entry: total granulocyte count \> or equal to 1000/microliter; platelet count \> 100,000/microliter
•Hepatic Function: Serum SGOT \& total bilirubin \< or equal to 2.5 times ULN.
•Note: All lab parameters must have been obtained within 1 week of registration
•Consent: Signed informed consent, approved by IRB, will be obtained prior to initiating treatment
•Corticosteroids: For patients currently on corticosteroids, patients should be on stable dose for 1 week prior to study entry, if clinically possible.
•Prior Therapy: Interval of at least 2 weeks between prior surgical resection or prior radiotherapy (XRT) or 1 week from completion of chemotherapy and all toxicities are \< or equal to grade 1 \& enrollment on this protocol unless there is unequivocal evidence of progressive disease.

Exclusion Criteria

•Pregnant or breast feeding women or women or men with reproductive potential not practicing adequate contraception. This therapy may be associated with potential toxicity to the fetus or child that exceeds minimum risks necessary to meet health needs of mother
•Active infection requiring intravenous antibiotics
•Prior failure with either topotecan or temozolomide

Arms & Interventions

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

Intervention: Oral Topotecan and Temodar