Status:
COMPLETED
Epothilone in Recurrent Glioblastoma Patients
Lead Sponsor:
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Conditions:
Glioblastoma
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief 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.
Detailed Description
Malignant gliomas remain among the most devastating cancers, and especially for recurrent GBM no standard treatment has been established to date. ZK 219477 is a fully synthetic analogue of Epothilone...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00397072
Start Date
June 1 2006
End Date
December 1 2008
Last Update
April 17 2014
Active Locations (1)
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1
Istituto Nazionale Neurologico
Milan, Italy, 20133