Lung Cancer Clinical Trial
— CIRABOfficial title:
Cilengitide (EMD121974) in Combination With Whole Brain Radiotherapy in Patients With Brain Metastases From Lung Cancer - a Single-center, Open-label Phase I Study
Verified date | May 2024 |
Source | Universitätsmedizin Mannheim |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 19 |
Est. completion date | October 2012 |
Est. primary completion date | October 2012 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Germany | University Medical Center, Department of Surgery | Mannheim |
Lead Sponsor | Collaborator |
---|---|
Universitätsmedizin Mannheim | Heidelberg University |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Dose-limiting toxicity | (i) Any grade III-IV non-hematological toxicity as defined by CTCAE, version 3.0, with the exclusion ofalopecia, nausea, vomiting, and fever that can be rapidly contolled with appropriate measures; (ii) absolute neutrophil count (ANC)<0.5x10'/L lasting for >7days; (iii) febrile neutropenia defined as ANC <1.0x10'/L and fever >38.5°C; (iv) platelets <25x10'/L or thrombocytopenic bleeding requiring transfusion; and (v) severe hypotension requiring dopamine administration. | 12 days | |
Primary | Maximum-tolerated dose | 5 planned steps to be tested: 100, 250, 500, 750, to 1000mg; the highest dose at which one or no DLT will have been observed among 6 patients | 12 days | |
Secondary | Overall response rate | Any response to treatment | 12 weeks | |
Secondary | Overall survival | Death as event, Kaplan-Meier (KM) | 1 year | |
Secondary | Brain-specific progression-free survival (PFS) | Every recurrence within the brain or death is an event, Kaplan-Meier (KM) | 1 year | |
Secondary | Tumor-specific PFS | Every tumor related event or death will be counted, Kaplan-Meier (KM) | 1 year | |
Secondary | Changes in functional MRI imaging (time to peak) at 6 and 12 weeks | time-to-peak measurements | 12 weeks | |
Secondary | Changes in functional MRI imaging (blood flow) at 6 and 12 weeks | blood flow measurements | 12 weeks | |
Secondary | Changes in functional MRI imaging (blood volume changes) at 6 and 12 weeks | blood volume changes during functional MRI | 12 weeks | |
Secondary | Evidence of early response by functional MRI on days 1, 4, and 12 | (ASL technique) on day 1,4 and 12, immediately before and after the administration of cilengitide. | 12 days | |
Secondary | Changes of neurocognitive function tests (intelligence) at 6 and 12 weeks | Intelligence was measured with a multiple-choice test of vocabulary knowledge. | 12 weeks | |
Secondary | Changes of neurocognitive function tests (memory figures) at 6 and 12 weeks | Memory was tested by aims of "Medical College of Georgia Complex Figures" | 12 weeks | |
Secondary | Changes of neurocognitive function tests (memory verbal) at 6 and 12 weeks | Memory was tested by aims of "Rea Auditory Verbal Learning Test - German Version" | 12 weeks | |
Secondary | Changes of neurocognitive function tests (perception) at 6 and 12 weeks | Perception was assessed by the "Digit Symbol Substitution Test" | 12 weeks | |
Secondary | Changes of neurocognitive function tests (attention/alertness) at 6 and 12 weeks | Attention was tested by "Alertness" | 12 weeks | |
Secondary | Changes of neurocognitive function tests (attention) at 6 and 12 weeks | Attention was tested by "Divided Attention" | 12 weeks | |
Secondary | Changes of neurocognitive function tests (attention speaking) at 6 and 12 weeks | Attention was tested by "Go,A.lo-Go". | 12 weeks | |
Secondary | Fatigue at 6 and 12 weeks | "Functional Assessment of Cancer Therapy - Fatigue Subscale" measured in points (range 0-52) | 12 weeks | |
Secondary | Anxiety/depression at 6 and 12 weeks | "Hospital Anxiety and Depression Scale - German Version" | 12 weeks | |
Secondary | Activities of daily living (Barthel) at 6 and 12 weeks | "Barthel Activities of Daily Living Index" measured in points (range 0-100) | 12 weeks | |
Secondary | Activities of daily living (instrumental) at 6 and 12 weeks | "lnstrumental Activities of Daily Living Scale" measured in points (range 0-8) | 12 weeks |
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