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

• Status: Unknown status
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Universitätsmedizin Mannheim
• Collaborator: Heidelberg University

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