Clinical trial NCT00948389: Study of CCNU (Lomustine) Plus Dasatinib in Recurrent Glioblastoma (GBM)
Official title: Randomized Phase II of Lomustine Versus Lomustine-Dasatinib in Patients With Recurrent Glioblastoma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Glioblastoma
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
Collaborators: name: European Organisation for Research and Treatment of Cancer - EORTC
First posted: 2009-07-29
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To determine whether dasatinib plus lomustine are effective for treatment of recurrent glioblastoma


Eligibility 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

Primary outcomes:
measure: Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, and Discontinuations Due to AEs
timeFrame: Assessed at baseline, every 2 weeks during cycles 1-6 (6-week cycles), and every 6 weeks after cycle 6. Median number of cycles = 1.0 (range: 1.0 - 7.0).
measure: Number of Participants With Dose-limiting Toxicities (DLTs)
timeFrame: The duration for observation of DLT was 2 6-week cycles in participants with escalated dose (QD to BID) and 1 6 -week cycle for participants starting with BID regime. For participants receiving dasatinib at 150 mg, DLTs were only documented over cycle 1.
measure: Deaths Within 30 Days of Protocol Treatment Discontinuation
timeFrame: From time of randomization through within 30 days after protocol treatment discontinuation. Median (full range) number of 6-week treatment cycles was 1.0 (1.0-7.0).
measure: Number of Participants With Worst Grade of Hematological Toxicity Per NCI CTCAE Version 3.0 Criteria
timeFrame: Assessed at baseline, every 2 weeks during cycles 1-6 (6-week cycles), and every 6 weeks after cycle 6. Median number of cycles = 1.0 (range: 1.0 - 7.0).
measure: Number of Participants With Worst Grade of Biochemistry Abnormality Per NCI CTCAE Version 3.0 Criteria
timeFrame: Assessed at baseline, every 2 weeks during cycles 1-6 (6-week cycles), and every 6 weeks after 6 cycles. Median number of cycles = 1.0 (range: 1.0 - 7.0).
Secondary outcomes:
Other outcomes:
measure: Number of Participants With Disease Progression at 12 Months
timeFrame: 12 months
Locations:
city: Paris Cedex
country: France
facility: Local Institution
city: Bologna
country: Italy
facility: Local Institution
city: Nijmegen
country: Netherlands
facility: Local Institution
city: Rotterdam
country: Netherlands
facility: Local Institution
city: Lausanne
country: Switzerland
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: