Phase II Study of ZK 219477 in patients with recurrent glioblastoma

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 0

Inclusion Criteria

Patients with histologically proven glioblastoma (according to the WHO classification ; the presence of oligodendroglial elements is allowed provided these make up less than 25% of the tumor).
? Recurrent disease documented by MRI after failing prior therapy (usually standard RT with concomitant and maintenance temozolomide ).
? Patients with multifocal disease not amenable to radiotherapy are eligible, provided they have received no or no more than 1 line of prior chemotherapy.
? Presence of at least one bidimensionally measurable target lesion (contrast enhancing lesion) with a largest diameter of at least 2cm, based on MRI scan done within two weeks prior to registration.
? No prior chemotherapy for recurrent disease, or a maximum of only one prior chemotherapy regimen given as adjuvant treatment. In all cases, prior chemotherapy must be completed for at least 4 weeks (or 6 weeks if a nitrosoureas contain regimen was used) prior to registration on study.
? Patients who received concomitant/adjuvant temozolomide as first-line therapy are eligible.
? Age = 18 years.
? WHO Performance status 0-2.
? Patients must be on a stable or decreasing dose of corticosteroids for at least one week prior to inclusion/registration.
? No prior surgery for recurrent primary brain tumor within the last 3 months prior to registration, except if immediate (within 72 hours) post operative imaging is available documenting clearly measurable residual disease or a postoperative follow up gives evidence of a progressive and measurable target lesion, or a second measurable target lesion outside the surgical area is present.
? Completion of prior radiotherapy to the brain for more than 3 months prior to registration.
? No prior treatment with high dose radiotherapy (> 65 Gy), stereotactic radiosurgery or internal radiation therapy unless the recurrence is subsequently histologically confirmed.
? Patients must not be taking antiepileptic agents or be on nonenzyme inducing antiepileptic drugs (EIAED). Patients taking phenytoin, carbamazepin or phenobarbital are not eligible.
? For patients on EIAED, they should have been switched to non-EIAEDs with a wash-out period of at least one month.
? Normal hematological functions: neutrophils = 1.5 x 109 cells/l, platelets =100 x 109 cells/l
? Normal liver function: bilirubin < 1.5 x ULN, alkaline phosphatase and transaminases (ASATALAT) < 2.5 times the upper limit of the normal range.
? Serum creatinine < 1.5 x ULN.
? Clinically normal cardiac function without history of ischemic heart disease in the past 12 months. Absence of cardiac insufficiency NYHA grade III and IV, instable angina, arrhythmia.
Patients with stable ischemic heart disease (e.g. treated prior angina, stable under appropriate therapy) are eligible.
? No previous or current malignancy at other sites with the exception of cone biopsied carcinoma of the cervix and adequately treated basal or squamous cell skin carcinoma.
? All patients (male and female) must use effective contraception methods according to CPMP/ICH/286/95 if of reproductive potential (e.g. implants, injectables, combined oral contraceptives, IUDs, sexual abstinence or vasectomised partner).
? Females must not be pregnant at entry or lactating.
? Absence of any psychological, familial, sociological or geographical factors potentially hampering compliance with the study protocol and follow-up schedule
There is no reason to believe that the representation would differ in the studied populat

Exclusion Criteria

Not provided

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The principal objective of the trial is to assess the therapeutic activity of ZK 219477 in patients with recurrent GBM.;Secondary Objective: Secondary objectives are the documentation of the safety profile, the mechanism of<br>action and the pharmacokinetic of ZK 219477.;Primary end point(s): The principal end-point is treatment success.<br>Secondary endpoints are the objective response as defined by the McDonald’s criteria, duration of response and progression-free survival and overall survival at 6 and 12 months. All patients will be followed until death.

Secondary Outcome Measures

Name	Time	Method

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