Status:
COMPLETED
Study With Nelfinavir and Combined Radiochemotherapy for Glioblastoma
Lead Sponsor:
Maastricht Radiation Oncology
Collaborating Sponsors:
Maastricht University Medical Center
Conditions:
Glioblastoma
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
The objectives of the trial are: To assess safety, tolerability and activity of nelfinavir given neo-adjuvant and concomitant to chemoradiotherapy with temozolomide in patients with a newly diagnosed...
Detailed Description
Glioblastoma multiforme is the most malignant and common, about 50%, variant of all primary brain tumours. The treatment strategies for this disease have not changed appreciably for many years consist...
Eligibility Criteria
Inclusion
- Histologically confirmed glioblastoma multiforme at primary diagnosis
- Tumours which do enhance on pre-operative imaging
- Age \>=18-65 years
- WHO performance status 0-2, RTOG- RPA class III-IV.
- No recent (\< 3 months) severe cardiac disease (arrhythmia, congestive heart failure, infarction)
- Patient able to tolerate full course of radiotherapy
- No previous radiotherapy to the head and neck area.
- Prior neurosurgery within 6 weeks of treatment
- No previous irradiation of the brain.
- No previous chemotherapy
- No prior or concurrent medical condition which would make treatment difficult to complete. Medication with steroids is allowed.
- No use of terfenadine, astemizol, cisapride, sildenafil, lovastatin or simvastatin and other concurrent medication that is metabolized by the CYP3A4 isoenzyme and cannot be replaced with other equivalent medications for the period of the study: antiarrhythmics (amiodarone, quinidine), neuroleptics (pimozide), sedative/hypnotic agents (midazolam, triazolam), ergot derivatives (dihydroergotamine, ergonovine, ergotamine, methylergonovine), HMG-CoA reductase inhibitors (atorvastatin), rifampin, rifabutin, felodipine, nifedipine, and sildenafil or St. John's wort.
- Adequate haematological, renal and hepatic function
- No uncontrolled infectious disease, absence of known HIV infection, chronic hepatitis B or hepatitis C infection
- Absence of any medical condition, which could interfere with oral medication intake (e.g., frequent vomiting, partial bowel obstruction)
- All patients of reproductive potential (male and female) must use effective contraception for the whole duration of the treatment and until 6 months thereafter. Females must not be pregnant or lactating
- Willing and able to comply with the study prescriptions
- Written informed consent before patient registration
Exclusion
- The opposite from above
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2013
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT00694837
Start Date
March 1 2009
End Date
January 1 2013
Last Update
April 10 2015
Active Locations (1)
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1
Maastricht Radiation Oncology
Maastricht, Netherlands, 6202 AZ