Clinical trial · Interventional
Cilengitide and Whole-Brain Radiation Therapy in Treating Patients With Brain Metastases From Lung Cancer
Cilengitide (EMD121974) in Combination With Whole Brain Radiotherapy in Patients With Brain Metastases From Lung Cancer - a Single-center, Open-label Phase I Study
NCT00884598CI-TRIAL-00077043CIRABcompletedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain and Central Nervous System Tumors | — | UNRESOLVED | — |
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cilengitide | Drug | — | UNRESOLVED |
| pharmacological study | Other | — | UNRESOLVED |
| radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Cilengitide
- interventionNames
- Drug: cilengitide
- Other: pharmacological study
- Radiation: radiation therapy
Primary outcomes (2)
- measure
- Dose-limiting toxicity
- timeFrame
- 12 days
- description
- (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.
- measure
- Maximum-tolerated dose
- timeFrame
- 12 days
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.