Cilengitide and Whole-Brain Radiation Therapy in Treating Patients With Brain Metastases From Lung Cancer (CIRAB)
Recruitment status was: Recruiting
RATIONALE: Cilengitide may stop the growth of brain metastases by blocking blood flow to the tumor. Radiation therapy uses high energy X-rays to kill tumor cells. Giving cilengitide together with radiation therapy may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of cilengitide when given together with whole-brain radiation therapy in treating patients with brain metastases from lung cancer.
Brain and Central Nervous System Tumors
Other: pharmacological study
Radiation: radiation therapy
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Cilengitide (EMD121974) in Combination With Whole Brain Radiotherapy in Patients With Brain Metastases From Lung Cancer - a Single-center, Open-label Phase I Study|
- Dose-limiting toxicity
- Maximum-tolerated dose
- Overall response rate
- Overall survival
- Brain-specific progression-free survival (PFS)
- Tumor-specific PFS
- Changes in functional MRI imaging studies at 6 and 12 weeks
- Evidence of early response by functional MRI on days 1, 4, and 12
- Changes of neurological and neurocognitive function tests at 6 and 12 weeks
- Safety and toxicity of the combination of cilengitide and whole-brain radiation therapy
- Pharmacokinetics of cilengitide
|Study Start Date:||December 2008|
|Estimated Study Completion Date:||December 2011|
|Estimated Primary Completion Date:||December 2011 (Final data collection date for primary outcome measure)|
- 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 lung cancer.
- 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 unacceptable toxicity.
Patients undergo blood sample collection on days 1, 4, 5, and 12 for pharmacokinetic studies.
After completion of study treatment, patients are followed for 10 weeks.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00884598
|University Medical Center, Department of Surgery|
|Mannheim, Germany, D-68167|
|Principal Investigator:||Christian Manegold, MD||University Medical Center Mannheim|