NCT00884598

Cilengitide and Whole-Brain Radiation Therapy in Treating Patients With Brain Metastases From Lung Cancer

Cilengitide (EMD121974) in Combination With Whole Brain Radiotherapy in Patients With Brain Metastases From Lung Cancer - a Single-center, Open-label Phase I Study

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Universitätsmedizin Mannheim · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

OBJECTIVES: * Primary * 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. * Secondary * 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. OUTLINE: 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.

Conditions

• Brain and Central Nervous System Tumors
• Lung Cancer

Interventions

Type	Name	Description
DRUG	cilengitide
OTHER	pharmacological study
RADIATION	radiation therapy

Timeline

• Start date: 2008-12-01
• Primary completion: 2012-10-01
• Completion: 2012-10-01
• First posted: 2009-04-21
• Last updated: 2024-05-10

Locations

1 site across 1 country: Germany