Clinical trial NCT00610571: Ph I Oral Topotecan and Temozolomide for Patients With Malignant Gliomas
Official title: Phase I Trial of Oral Topotecan Plus Temodar in the Treatment of Patients With Malignant Gliomas
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Glioblastoma
Gliosarcoma
Anaplastic Astrocytoma
Keywords: Temodar
Temozolomide
Topotecan
Hycamtin
Malignant Gliomas
Brain tumor
Anaplastic astrocytoma
AA
GBM
Glioblastoma Multiform
Gliosarcoma
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
name: Schering-Plough
First posted: 2008-02-08
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.
* 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

Primary outcomes:
measure: maximum tolerated dose
timeFrame: 6 months
Secondary outcomes:
measure: Safety & efficacy
timeFrame: 6 months
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Health System
state: North Carolina
Study officials:
affiliation: Duke Health
name: Katherine B Peters, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: