Status:
COMPLETED
Ph I Oral Topotecan and Temozolomide for Patients With Malignant Gliomas
Lead Sponsor:
Katy Peters
Collaborating Sponsors:
GlaxoSmithKline
Schering-Plough
Conditions:
Glioblastoma
Gliosarcoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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...
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 ex...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT00610571
Start Date
April 1 2004
End Date
April 1 2012
Last Update
October 25 2013
Active Locations (1)
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1
Duke University Health System
Durham, North Carolina, United States, 27710