Ph I Oral Topotecan and Temozolomide for Patients With Malignant Gliomas

Phase 1

Completed

• Conditions: Anaplastic Astrocytoma; Glioblastoma; Gliosarcoma
• Interventions: Drug: Oral Topotecan and Temodar

• Registration Number: NCT00610571
• Lead Sponsor: Katy Peters

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.

Study Timeline

• Study Start: 2004-04
• Study First Submitted: 2008-01-28
• Study First Submitted QC: 2008-02-07
• Study First Posted: 2008-02-08
• Primary Completion: 2009-09
• Study Completion: 2012-04
• Status Verified: 2013-10
• Last Update Submitted: 2013-10-23
• Last Update Posted: 2013-10-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

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 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Oral Topotecan and Temodar	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

Primary Outcome Measures

Name	Time	Method
maximum tolerated dose	6 months

Secondary Outcome Measures

Name	Time	Method
Safety & efficacy	6 months

Trial Locations

Locations (1)

Duke University Health System; 🇺🇸 Durham, North Carolina, United States