Ph I Oral Topotecan and Temozolomide for Patients With Malignant Gliomas
NCT ID: NCT00610571
Last Updated: 2013-10-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
62 participants
INTERVENTIONAL
2004-04-30
2012-04-30
Brief Summary
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* 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
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Active infection requiring intravenous antibiotics
* Prior failure with either topotecan or temozolomide
18 Years
ALL
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Schering-Plough
INDUSTRY
Katy Peters
OTHER
Responsible Party
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Katy Peters
Assistant Professor
Principal Investigators
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Katherine B Peters, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Duke Health
Locations
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Duke University Health System
Durham, North Carolina, United States
Countries
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Related Links
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The Preston Robert Tisch Brain Tumor Center at DUKE
Other Identifiers
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5487
Identifier Type: OTHER
Identifier Source: secondary_id
Pro00003970
Identifier Type: -
Identifier Source: org_study_id