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Phase III Study of Imatinib Mesylate in Combination With Hydroxyurea Versus Hydroxyurea Alone as an Oral Therapy in Patients With Temozolomide Resistant Progressive Glioblastoma

Phase 3
18 Years
70 Years
Not Enrolling
Glioblastoma Multiforme, Astrocytoma

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Trial Information

Phase III Study of Imatinib Mesylate in Combination With Hydroxyurea Versus Hydroxyurea Alone as an Oral Therapy in Patients With Temozolomide Resistant Progressive Glioblastoma

Inclusion Criteria:

- Signed informed consent prior to initiation of any study procedure.

- Patients >= 18 years of age.

- Histological confirmed diagnosis of glioblastoma multiforme / astrocytoma World
Health Organization (WHO) grade IV by a reference pathologist

- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1 or 2.

- Adequate hepatic, renal and bone marrow function as defined by the following: total
bilirubin < 1.5 x Upper Limit of Normal (ULN), ALT and AST < 2.5 x ULN, creatinine <
1.5 x ULN, absolute neutrophil count > 1.5 x109/L, platelets > 100 x109/L and
hemoglobin > 10 g/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 MRI 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.

- Patients with other malignant disorders.

- Patient with acute or known chronic liver disease (i.e., chronic active hepatitis,

- 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

- 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

Other protocol-specific inclusion /exclusion criteria may apply.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Percentage of Participants With Progression Free Survival (PFS) During the Study Duration

Outcome Description:

PFS was defined as the time from the date of randomization to the date of the first documented progression according to the MacDonald criteria, or death due to any cause. MacDonald criteria are standard criteria in neurooncology. Tumor assessment was made according to the adapted MacDonald criteria based on the combined evaluation of 1) assessment of the MRI scan for measurable, evaluable, and new lesions (made by the independent external expert too), 2) overall assessment of neurological performance (made by the investigator), 3) concomitant steroid use (as reported by the investigator).

Outcome Time Frame:

6 months -1 year

Safety Issue:


Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals


European Union: European Medicines Agency

Study ID:




Start Date:

October 2004

Completion Date:

Related Keywords:

  • Glioblastoma Multiforme
  • Astrocytoma
  • Open label
  • Imatinib mesylate
  • hydroxyurea
  • temozolomide
  • resistant
  • protein tyrosine kinases
  • adenocarcinoma
  • glioblastoma multiforme
  • astrocytoma
  • brain tumor
  • brain cancer
  • Astrocytoma
  • Glioblastoma