EUCTR2006-001659-37-NLActive, not recruitingPhase 1
Phase II Study of ZK 219477 in patients with recurrent glioblastoma
European Organisation for Research and Treatment of Cancer0 sites0 target enrollmentStarted: September 13, 2006Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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 of males and females would differ i
Exclusion Criteria
- Not provided
Investigators
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