CIRABCilengitide (EMD121974) in Combination With Whole Brain Radiotherapy in Patients With Brain Metastases From Lung Cancer - a Single-center, Open-label Phase I Study
cilengitide
+ pharmacological study
+ radiation therapy
Brain Diseases+13
+ Brain Neoplasms
+ Bronchial Neoplasms
Treatment Study
Summary
Study start date: December 1, 2008
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.19 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: DISEASE CHARACTERISTICS: * Histologically confirmed lung cancer (small cell or non-small cell lung cancer) * Patient must be eligible for whole-brain radiotherapy * Presence of brain metastasis (single or multiple, synchronous or metachronous) from lung cancer not amenable to surgery or radiosurgery (presence of metastases at any other site is allowed) * No leptomeningeal metastasis or known subarachnoid spread of tumor PATIENT CHARACTERISTICS: * ECOG performance status (PS) 0-1 (ECOG PS 2 allowed if due to the presence of cerebral metastases and not due to a high peripheral-tumor load or other reasons) * Life expectancy ≥ 3 months * Adequate hematologic function * Total bilirubin \< 1.5 times upper limit of normal (ULN) * AST, ALT, and alkaline phosphatase \< 2.5 times ULN * Creatinine clearance \> 60 mL/min * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 6 months after completion of study treatment * No history of acute or chronic renal disease * No other malignancies treated within the past 5 years, except adequately treated carcinoma in situ of the cervix or basal cell carcinoma of the skin * No uncontrolled hypertension * No history of coagulation disorder associated with bleeding or recurrent thrombotic events * No peptic ulcer disease within the past 6 months * No congestive heart failure, high risk for uncontrolled arrhythmia, or history of clinically significant coronary heart disease * No known alcohol or drug abuse * No other significant or acute concomitant disease * No dementia or altered mental status PRIOR CONCURRENT THERAPY: * See Disease Characteristics * Concurrent corticosteroids allowed if the dosing regimen has ben stable ≥ 5 days * Concurrent anticonvulsants allowed if the dosing regimen has been stable for the past week * More than 30 days since prior participation in another clinical trial * No concurrent anticoagulation with vitamin K antagonists, therapeutic-dose anticoagulation with heparin resulting in prolonged PTT, or therapeutic-dose anticoagulation with low molecular weight heparin (low-dose \[i.e. prophylactic\], low molecular weight heparins allowed) * No prior whole-brain radiation or radiosurgery * No prior antiangiogenic therapy * No other concurrent anticancer therapy
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
University Medical Center, Department of Surgery
Mannheim, GermanyOpen University Medical Center, Department of Surgery in Google Maps