Second line therapy with low dose fotemustine in progressive malignant gliomas - fotgm
- Conditions
- Progressive malignant gliomas patientsMedDRA version: 9.1Level: LLTClassification code 10006131Term: Brain neoplasm malignant
- Registration Number
- EUCTR2008-003342-29-IT
- Lead Sponsor
- ISTITUTI FISIOTERAPICI OSPITALIERI
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
Anaplastic gliomas
Measurable disease
Previous treatment including alkilating agent
Age > 18 years
Karnofsky PS >= 60
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Presence of cardiac disease
Previous radiotherapy within 60 days
Previous treatment with fotemustine or other nitrosurees
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Activity in terms of response rate and time to progression;Secondary Objective: Tolerability<br>MGMT methilation and relationship with efficacy;Primary end point(s): Response rate<br>Time to progression
- Secondary Outcome Measures
Name Time Method