Phase II Study of ZK 219477 in patients with recurrent glioblastoma

European Organisation for Research and Treatment of Cancer0 sites0 target enrollmentAugust 1, 2007

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

August 1, 2007

End Date

June 16, 2008

Last Updated

6 years ago

Study Type

Interventional clinical trial of medicinal product

Investigators

Sponsor

European Organisation for Research and Treatment of Cancer

Eligibility Criteria

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.