Epothilone in Recurrent Glioblastoma Patients

• Status: Completed
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this single arm phase II study is to evaluate safety and efficacy of ZK 219477 in the treatment of temozolomide pre-treated, recurrent GBM patients.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
• Treatments: Epothilones; Sagopilone

Criteria

Inclusion Criteria:

• Age between 18 and 70 years

• KPS ≥ 70

• Life expectancy of at least 3 months

• Presence of at least one bi-dimensionally measurable lesion on gadolinium (Gd)-enhanced MRI, indicating progressive or recurrent disease at least 8 weeks after standard external-beam radiotherapy

• Recurrence or progression after treatment with radiotherapy and temozolomide. Also patients with residual disease after surgery for recurrent GBM will be included

• Adequate bone marrow reserve (leukocytes ≥ 3,500/ml, ANC ≥ 1,500/ml, platelets ≥100,000/ ml); normal baseline liver (serum bilirubin ≤ 20 /mol/ L), renal (serum creatinine <150 /mol/L) and cardiac function

• Absence of infectious disease, debilitating chronic diseases, and known psychiatric disorders

• Corticosteroid dose stable for at least 1 week

• Adequate recovery from previous surgery, radiation and chemotherapy

• Negative pregnancy test at enrolment in females of child-bearing potential

• Agreement to use highly effective contraception methods in adults of reproductive potential

• Fully informed written consent

Exclusion Criteria:

• Pregnant women

• Patients who have had chemotherapy or radiotherapy within 4 weeks

• History of allergic reactions attributed to compounds of similar chemical or biologic composition to ZK219477

• Uncontrolled inter current illness including, but not limited, to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

• HIV-infection

• Any prior treatment with epothilones, other tubulin-targetting as taxanes (e.g. paclitaxel, docetaxel) and vinca alkaloids (e.g. vincristine, vinblastine, vinorelbine)

• Peripheral neuropathy

• Any concurrent malignancy other than non-melanoma skin cancer or carcinoma in situ of the cervix

• Active infection

• Breast-feeding

• Subjects who have received an experimental drug or have participated in a clinical trial within 3 months prior to screening

• Employees of the investigator or study centre with direct involvement in the proposed study or other studies under the direction of that investigator or study centre