Ph I Oral Topotecan and Temozolomide for Patients With Malignant Gliomas (NCT00610571) | Clinical Trial Compass
CompletedPhase 1
Ph I Oral Topotecan and Temozolomide for Patients With Malignant Gliomas
United States62 participantsStarted 2004-04
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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.
* Patients with Reproductive Potential: Patients must agree to practice effective birth control measures while on study and for 2 months after completing therapy
Exclusion Criteria:
* Pregnant or breast feeding women or women or …