recurrent glioblastoma MedDRA version: 9.1 Level: LLT Classification code 10018336 Term: Glioblastoma
Conditions
Sponsors
Bristol Myers Squibb International Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: *Patients with histological or cytological proven glioblastoma multiforme, including anaplastic oligoastrocytoma with necrosis. * Recurrent or progressive disease documented by MRI after prior therapy (standard radiotherapy with concomitant and adjuvant temozolomide), within at least two weeks prior to registration/randomization on study. No other chemotherapy regimens apart from temozolomide are allowed. Prior exposure in the adjuvant setting to biotherapies/targeted agent is allowed if at least 4 weeks have elapsed since end of treatment and patients have recovered from all toxicity. * Patient may have been operated for recurrence. If operated, residual and measurable disease after surgery is not required but surgery must have confirmed the recurrence. In case of operation, a postsurgery MRI must be available within 48 hours following surgery. Surgery should be completed for at least 2 weeks before registration and patients should have fully recovered. * For non operated patients, recurrent disease must be at least one bidimensionally measurable target lesion (contrast enhancing lesion) with one diameter of at least 2 cm, based on MRI scan done within two weeks prior to registration/randomization. * For the safety phase only: Patients respiratory function evaluated by carbon monoxide diffusion capacity (DLCO) must be more than 60 % of the predicted value. * Age = 18 years. * WHO Performance status 0 - 2 * Patients must be on a stable or decreasing dose of corticosteroids for at least 1 week prior to treatment start, regardless of their surgical status. * Completion of prior radiotherapy to the brain more than 3 months prior to the diagnosis of progression. * Patients must not be taking antiepileptic agents or be on non-enzyme inducing antiepileptic drugs (non-EIAED). Patients on EIAED who require anti-convulsant therapy must have been switched to non-EIAEDs two weeks prior to study entry. * Normal hematological functions: neutrophils = 1.5 x 10E9 cells/l, platelets =100 x 10E9 cells/l * Normal liver function: bilirubin 35 mIU/mL - Women who are using oral contraceptives, other hormonal contraceptives (vaginal products, skin patches, or implanted or injectable products), or mechanical
Exclusion criteria
Exclusion criteria: * Prior chemotherapy for recurrent disease. * Prior Gliadel wafers. * Prior treatment with high dose radiotherapy (> 65 Gy), stereotactic radiosurgery or internal radiation therapy unless the recurrence is subsequently histologically confirmed. * History of pulmonary disease that may affect pulmonary functions including obstructive chronic broncho-pneumopathy, concurrent pleural effusion and interstitial pneumonia. * Presence of cardiac insufficiency NYHA grade III and IV, unstable angina, arrhythmia. Patients with stable ischemic heart disease for at least 12 months (e.g. treated prior angina, stable under appropriate therapy) are eligible. * Previous or current malignancy at other sites within the last 3 years with the exception of cone biopsied carcinoma of the cervix and adequately treated basal or squamous cell skin carcinoma
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The general objectives are to assess the safety of combining dasatinib with CCNU as well as to assess the activity of this combination and CCNU alone in GBM patients who have relapsed after temozolomide concurrent with and adjuvant to radiotherapy.;Secondary Objective: ;Primary end point(s): Safety phase: The primary end-point will be the safety and tolerance of dasatinib-CCNU combination in order to establish a recommended dose for the phase II part. Phase II part: The principal end-point will be PFS probability at 6 months /Patients alive and free of progression at 6 months. | — |
Countries
Belgium, France, Italy, Netherlands, United Kingdom
Outcome results
None listed