Status:
COMPLETED
Cilengitide and Whole-Brain Radiation Therapy in Treating Patients With Brain Metastases From Lung Cancer
Lead Sponsor:
Universitätsmedizin Mannheim
Collaborating Sponsors:
Heidelberg University
Conditions:
Brain and Central Nervous System Tumors
Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 radi...
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT00884598
Start Date
December 1 2008
End Date
October 1 2012
Last Update
May 10 2024
Active Locations (1)
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1
University Medical Center, Department of Surgery
Mannheim, Germany, D-68167