Cilengitide and Whole-Brain Radiation Therapy in Treating Patients With Brain Metastases From Lun… (NCT00884598) | Clinical Trial Compass
CompletedPhase 1
Cilengitide and Whole-Brain Radiation Therapy in Treating Patients With Brain Metastases From Lung Cancer
Germany19 participantsStarted 2008-12
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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 he…