Status:
TERMINATED
Study of CCNU (Lomustine) Plus Dasatinib in Recurrent Glioblastoma (GBM)
Lead Sponsor:
Bristol-Myers Squibb
Collaborating Sponsors:
European Organisation for Research and Treatment of Cancer - EORTC
Conditions:
Glioblastoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
To determine whether dasatinib plus lomustine are effective for treatment of recurrent glioblastoma
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT00948389
Start Date
October 1 2009
End Date
May 1 2011
Last Update
August 31 2012
Active Locations (5)
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1
Local Institution
Paris, France, 75013
2
Local Institution
Bologna, Italy, 40139
3
Local Institution
Nijmegen, Netherlands, 6525 GA
4
Local Institution
Rotterdam, Netherlands, 3075 EA