Epothilone ZK-219477 in Treating Patients With Recurrent Glioblastoma

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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: This phase II trial is studying how well epothilone ZK-219477 works in treating patients with recurrent glioblastoma.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: European Organisation for Research and Treatment of Cancer - EORTC
• Treatments: Sagopilone

Criteria

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