Cilengitide (EMD121974) in Combination With Whole Brain Radiotherapy in Patients With Brain Metastases From Lung Cancer - a Single-center, Open-label Phase I Study
- To assess the safety and tolerability of daily cilengitide by determining its
dose-limiting toxicity and maximum-tolerated dose when combined with concomitant
fractionated whole-brain radiation therapy in patients with brain metastases from
- To collect evidence of the best overall response rate, overall survival,
brain-specific progression-free survival, and tumor-specific progression-free
survival of these patients.
- To collect evidence of changes in functional MRI imaging studies at 6 and 12 weeks
after initiation of therapy.
- To collect evidence of early response by functional MRI (ASL technique) on days 1,
4, and 12, immediately before and after the administration of cilengitide.
- To collect evidence of changes in neurological and neurocognitive function tests
at 6 and 12 weeks after initiation of therapy.
- To further evaluate the safety and toxicity of the combination of cilengitide and
whole-brain radiation therapy.
- To further evaluate the pharmacokinetics of cilengitide administered daily.
Patients receive oral cilengitide once daily and undergo whole-brain radiotherapy on the
same days. Treatment continues for 2 weeks in the absence of disease progression or
Patients undergo blood sample collection on days 1, 4, 5, and 12 for pharmacokinetic
After completion of study treatment, patients are followed for 10 weeks.
Masking: Open Label, Primary Purpose: Treatment
Christian Manegold, MD
University Medical Center Mannheim
Germany: Federal Institute for Drugs and Medical Devices