A phase II, open-label, multi-centre, single-arm study, evaluating the efficacy of Glivec® plus Hydroxyurea (HU) in patients with progressive glioblastoma multiforme (GBM), not receiving enzyme inducing anticonvulsant drugs (EIACDs).

ovartis Pharma Services AG0 sites110 target enrollmentAugust 27, 2008

DrugsGlivec Hydroxyurea medac

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Not specified
Sponsor: ovartis Pharma Services AG
Enrollment: 110
Status: Active, not recruiting
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

August 27, 2008

End Date

TBD

Last Updated

9 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

ovartis Pharma Services AG

Eligibility Criteria

Inclusion Criteria

•Waivers for protocol eligibility will not be granted. Patients must be fully eligible and have all pre\-testing in place to enter the study within the specified period.
•Patients must have histologically confirmed diagnosis of progressive primary GBM based on original diagnosis. Original histology slides must be available for central diagnostic review. Patients with prior low\-grade glioma are eligible if histological re\-assessment demonstrates transformation to GBM. The most recent histology slides or biopsy sample must be available for central diagnostic review.
•Patients must have no more than one prior episode of progressive disease following previously received surgery and/or radiation and only one prior chemotherapy exposure of either Temozolomide or nitrosourea. The chemotherapy could have been administered either in an adjuvant or later setting. The application of Gliadel wafers will be considered a regimen of nitrosourea chemotherapy.
•Patients must have measurable disease on gadolinium enhanced MRI
•Patients taking steroids: must have been on stable dose for 7 days or more
•ECOG performance score greater than or equal to 2
•Hemoglobin \=/\> 10g/dL (or Hematocrit \> 29%), ANC \> 1,500 cells/l, platelets \> 100,000 cells/l.
•Serum creatinine \< 1\.5 mg/dl, BUN \< 25 mg/dl, serum SGOT and bilirubin \< 1\.5 times upper limit of normal.
•Male and female patients with age equal or greater than 18 years
•Male and female patients who are sexually active must use double\-barrier contraception, oral contraceptive plus barrier contraceptive, or must have undergone clinically documented total hysterectomy and/or ovariectomy or tubal ligation.

Exclusion Criteria

•Patients who have received previous imatinib or hydroxyurea prior to study entry, or any investigational agent within the last 6 months
•Patients who have had a second course of chemotherapy
•Patients who have had a second course of radiotherapy are excluded, unless this was given as a single localized application of radiosurgery.
•Patients who are currently taking EIACDs (such as carbamazepine, phenobarbital, phenytoin, phosphenytoin, oxcarbamazepine, primadone). Previous EIACD should have been interrupted 4 weeks prior to study start.
•Patients with \= grade 2 peripheral edema, or pulmonary or pericardial effusions or ascites of any grade.
•Patients who are not a minimum of 12 weeks from completion of conventional external beam radiotherapy unless:
•there is new radiographical enhancement outside the field of radiation,
•or there is new pathological confirmation of recurrent tumor
•or progressive radiographical enhancement noted on post\-RT/TMZ continues to worsen after an additional course of TMZ.
•Patients who have an excessive risk of an intracranial hemorrhagic event (defined by stroke within the prior 6 months, history of CNS (excluding post\-operative grade 1\) or intraocular bleed.