Overview

Study of CCNU (Lomustine) Plus Dasatinib in Recurrent Glioblastoma (GBM)

Status:
Terminated
Trial end date:
2011-05-01
Target enrollment:
0
Participant gender:
All
Summary
To determine whether dasatinib plus lomustine are effective for treatment of recurrent glioblastoma
Phase:
Phase 1/Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Bristol-Myers Squibb
Collaborator:
European Organisation for Research and Treatment of Cancer - EORTC
Treatments:
Dasatinib
Lomustine
Criteria
Inclusion Criteria:

- Patients with histological or cytological proven glioblastoma multiforme

- Recurrent or progressive disease documented by magnetic resonance imaging (MRI)

- World Health Organization (WHO) Performance status 0 - 2

- Patient may have been operated for recurrence

- For non operated patients, recurrent disease must be at least one bidimensionally
measurable target lesion with one diameter of at least 2cm

- Patients must be on a stable or decreasing dose of corticosteroids for at least 1 week
prior to baseline MRI

Exclusion Criteria:

- Patients with histological or cytological proven glioblastoma multiforme

- Completion of radiotherapy to the brain less than 3 months prior to
registration/randomization

- Prior treatment with high dose radiotherapy, stereotactic radiosurgery or internal
radiation therapy

- Previous or current malignancy at other sites within prior 3 years