Phase III Study comparing Imatinib mesylate and hydroxyurea combination therapy with hydroxyurea monotherapy in patients with temozolomide resistant progressive glioblastoma

Condition	Intervention	Phase
Glioblastoma multiforme, astrocytoma	Drug: Imatinib mesylate; hydroxyurea	Phase III

Further Study Details: 

Ages Eligible for Study:  18 Years   -   70 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria • Signed informed consent prior to initiation of any study procedure. • Patients >= 18 years of age. • Histological confirmed diagnosis of glioblastoma multiforme / astrocytoma WHO grade IV by a reference pathologist • ECOG Performance Status of 0, 1 or 2. [Appendix 2] • Adequate hepatic, renal and bone marrow function as defined by the following: total bilirubin =< 1.5 x ULN, SGOT and SGPT =< 2.5 x ULN, creatinine =< 1.5 x ULN, ANC >= 1.5 x 109/L, platelets >= 100 x 109/L and Hgb >10g/dL.

• Female patients of childbearing potential with a negative pregnancy test within 7 days of initiation of study drug dosing. Postmenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential. Male and female patients of reproductive potential who agree to employ an effective barrier method of birth control throughout the study, and for up to 3 months following discontinuation of study drug.

• Life expectancy of >3 months. • MRI available every 6 weeks for disease management • No intercerebral inflammation • Irradiation therapy 54 to 62 gy finished or less according to national standard • Chemotherapy at least 1 temozolomide containing regimen finished, no established chemotherapy regiment available and progression under chemotherapy or in between 6 months following the last chemotherapy.

• Leucocytes > 2.500/µl, to be controlled once a week • Thrombocytes > 80.000/µl, to be controlled once a week • Ensured compliance • Patients who had a second or third resection after disease progression cannot be included earlier than 2 weeks following the resection. MRI should be performed not later than 72 h post operation. If patients are to be included later than 4 weeks after the resection, a new baseline MRT must be performed.

Exclusion Criteria • Female patients who are pregnant or breast-feeding. • Patients who have been treated with any investigational agent(s) within 28 days of the first day of administration of study drug.

• Patients with uncontrolled medical disease such as diabetes mellitus, thyroid dysfunction, neuropsychiatric disorders, infection, angina or Grade 3 or 4 cardiac problems as defined by the New York Heart Association Criteria [Appendix 3].

• Patients with other malignant disorders. • Patient with acute or known chronic liver disease (i.e., chronic active hepatitis, cirrhosis).

• Patients who are known to be HIV positive (no specific tests are required for confirmation of eligibility).

• Expected incompliance according to treatment, treatment diary and examination schedule • Not confirmed histological diagnosis glioblastoma multiforme/astrocytoma WHO grade IV • Other drugs with potential cytostatic main or side effect • No or inadequate chemotherapy or irradiation therapy • Patients without hematological recovery after previous chemotherapy who have been treated with Chemotherapy within 28 days of the first day of administration of study drug.

Please refer to this study by ClinicalTrials.gov identifier  NCT00154375

Novartis      41 61 324 1111 

Germany
      Dülmen,  Germany; Recruiting

Study chairs or principal investigators

Novartis,  Study Chair,  Novartis   

Study ID Numbers:  CSTI571BDE40
Last Updated:  September 9, 2005
Record first received:  September 9, 2005
ClinicalTrials.gov Identifier:  NCT00154375
Health Authority: European Union: European Medicines Agency; Germany: Federal Institute for Drugs and Medicinal Devices; Australia: Therapeutic Goods Administration; Sweden: Medical Projects Agency; Denmark: Danish Medicines Agency; Norway: Norwegian Medicines Agency; Finland: National Agency for Medicines
ClinicalTrials.gov processed this record on 2005-09-13