Status:
COMPLETED
Epothilone ZK-219477 in Treating Patients With Recurrent Glioblastoma
Lead Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Conditions:
Brain and Central Nervous System Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as epothilone ZK-219477, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. PURPOSE: ...
Detailed Description
OBJECTIVES: Primary * Assess the therapeutic activity of epothilone ZK-219477 in patients with recurrent glioblastoma. Secondary * Determine the safety profile, mechanism of action, and pharmacoki...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed glioblastoma
- Presence of oligodendroglial elements allowed provided they make up \< 25% of tumor
- Measurable disease, defined as ≥ 1 bidimensionally measurable target lesion with a largest diameter of ≥ 2 cm by MRI within the past 2 weeks
- Recurrent disease
- Documented by MRI after failing prior therapy (usually standard radiotherapy with concurrent and maintenance temozolomide)
- Subsequent histologic confirmation of recurrence required for patients who received prior high-dose radiotherapy (\> 65 Gy), stereotactic radiosurgery, or internal radiotherapy
- Multifocal disease that is not amenable to radiotherapy allowed provided the patient received no more than 1 line of prior chemotherapy
- PATIENT CHARACTERISTICS:
- WHO performance status 0-2
- Absolute neutrophil count ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- Bilirubin \< 1.5 times upper limit of normal (ULN)
- AST and ALT \< 2.5 times ULN
- Alkaline phosphatase \< 2.5 times ULN
- Creatinine \< 1.5 times ULN
- Clinically normal cardiac function
- No ischemic heart disease within the past 12 months
- Stable ischemic heart disease (e.g., treated angina that is stable under appropriate therapy) allowed
- No New York Heart Association class III or IV cardiac insufficiency
- No unstable angina
- No arrhythmia
- No psychological, familial, sociological, or geographical factors that would preclude study compliance
- No other malignancy except cone-biopsied carcinoma of the cervix or adequately treated basal cell or squamous cell skin cancer
- Not pregnant or nursing
- Negative pregnancy test
- Fertile female patients must use effective contraception during and for 3 months after completion of study treatment
- Fertile male patients must use effective contraception during and for 6 months after completion of study treatment
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas)
- More than 3 months since prior radiotherapy to the brain
- More than 3 months since prior surgery for recurrent primary brain tumor unless 1 of the following criteria are met:
- Measurable residual disease documented by immediate (within 72 hours) postoperative imaging
- Evidence of a progressive and measurable target lesion found at postoperative follow-up
- Presence of a second measurable target lesion outside the surgical area
- Prior adjuvant temozolomide as first-line therapy allowed
- No prior chemotherapy for recurrent glioblastoma
- One prior chemotherapy regimen given as adjuvant therapy allowed
- Concurrent corticosteroids allowed provided dose is stable or decreasing for ≥ 1 week
- No concurrent phenytoin, carbamazepine, or phenobarbital
- No concurrent Hypericum perforatum (St. John's wort)
- No concurrent enzyme-inducing antiepileptic drugs (EIAEDs)
- Patients on EIAEDs should have been switched to non-EIAEDs with a wash-out period of ≥ 1 month
- No other concurrent anticancer agents (except alternative or homeopathic medicine)
- No other concurrent investigational treatment
Exclusion
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT00424060
Start Date
December 1 2006
Last Update
September 24 2012
Active Locations (1)
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1
Centre Hospitalier Universitaire Vaudois
Lausanne, Switzerland, CH-1011