EUCTR2008-001078-34-NL
Active, Not Recruiting
Phase 1
Phase I/II study for patients with newly diagnosed glioblastoma testing nelfinavir in combination with radiotherapy and concomitant and adjuvant temozolomide
ConditionsPhase I/II study for patients with newly diagnosed glioblastoma testing nelfinavir in combination with radiotherapy and concomitant and adjuvant temozolomideMedDRA version: 9.1Level: LLTClassification code 10018336Term: GlioblastomaMedDRA version: 9.1Level: LLTClassification code 10018337Term: Glioblastoma multiforme
DrugsViracept 250
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Phase I/II study for patients with newly diagnosed glioblastoma testing nelfinavir in combination with radiotherapy and concomitant and adjuvant temozolomide
- Sponsor
- Maastro Clinic
- Enrollment
- 57
- Status
- Active, Not Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Histological confirmed glioblastoma multiforme at primary diagnosis
- •Tumours which do enhance on pre\-operative imaging
- •Age \>\=18\-65
- •WHO performance status 0\-2, RTOG\- RPA class III\-IV.
- •No recent (\< 3 months) severe cardiac disease (arrhythmia, congestive heart failure, infarction)
- •Willing and able to comply with the study prescriptions
- •Have given written informed consent before patient registration
- •Patient able to tolerate full course of radiotherapy
- •No previous radiotherapy to the head and neck area.
- •Prior neurosurgery within 6 weeks of treatment
Exclusion Criteria
- •the opposite of the above
Outcomes
Primary Outcomes
Not specified
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