Study Bendamustine Concurrent Whole Brain Radiation Brain Metastases From Solid Tumors

Stopped early · Phase 1

Conditions studied: Brain Metastases

In brief

The purpose of this study is to: * Test the maximum tolerated dose (MTD) of Bendamustine with whole brain radiation therapy (WBRT) * To determine the plasma pharmacokinetics (a blood test to see how much of the drug is getting into the patient's system and how long it lasts in the system) of Bendamustine * To determine the presence of Bendamustine in cerebrospinal fluid (CSF) (fluid from the brain and spinal cord) of study patients Bendamustine is approved by the Food and Drug Administration (FDA) for chronic lymphocytic leukemia. However, Bendamustine will be used in this study as an investigational agent.

Key facts

Study ID: NCT00879073
Run by: H. Lee Moffitt Cancer Center and Research Institute
People needed: 12
Starts: 2009-04-01
Expected to finish: 2012-12-01
Last updated by the study team: 2012-12-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Pathologically (histologically or cytologically) proven diagnosis of solid tumor malignancy within 5 years of registration. Pathological confirmation by pathologists at Moffitt Cancer Center is required.
Cerebral metastases from known solid tumors diagnosed by contrast-enhanced brain magnetic resonance imaging (MRI) or contrast-enhanced head computed tomography (CT) for patients unable to receive MRIs
Single metastases that have been resected
Patient may have had prior radiosurgery or surgical resection for brain metastasis. Patients should have completed prior therapy at least 14 days but no longer than 56 days prior to study entry.
Karnofsky Performance Status ≥ 70 within 28 days prior to study entry.
Expected life span of ≥ 3 months
Able to tolerate 3 week course of whole brain radiation therapy
Able to receive a lumbar puncture (for post-MTD patients only)
Adequate bone marrow, liver and renal function as assessed by the following: Hemoglobin > 9.0 g/dl; Absolute neutrophil count (ANC) > 1,500/mm³; Platelet count > 100,000/mm³; Total bilirubin < 1.5 x upper limit of normal (ULN); Alanine transaminase/Aspartic transaminase (ALT/AST) < 2.5 x the ULN (< 5 x ULN for patients with liver involvement); International normalized ratio (INR) < 1.5 or a prothrombin time/partial thromboplastin time (PT/PTT) within normal limits; Creatinine < 1.5 x ULN
Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of treatment.
Ability to understand and sign a study-specific written informed consent prior to study entry.
Patients receiving systemic therapy are eligible for this study if given >14 days prior to study entry and given no sooner than >14 days post radiation therapy (RT) completion.
Complete history and general physical examination within 28 days prior to study entry

You may not qualify if…

Known hypersensitivity to bendamustine or mannitol
Patients with cerebral metastases from unknown primary tumors
Patients with cerebral metastases from leukemias or lymphomas
Patients with uncontrolled systemic cancer (i.e. evidence of systemic disease progression < 3 months prior to study entry)
Systemic chemotherapy ≤14 days prior to study entry or ≤14 days after completing radiotherapy
Patients who received prior BCNU wafer (Gliadel®) implantation for surgically resected cerebral metastatic lesions
Patients with a life expectancy of less than 3 months
Patients who received prior whole brain radiation therapy. As noted above, patients who received prior radiosurgery are allowed
Patients with significant hydrocephalous
Active clinically serious infection > Common Terminology Criteria for Adverse Events (CTCAE) Grade 2
Pregnant or lactating women

Where it is running

H. Lee Moffitt Cancer Center & Research Institute — Tampa, Florida, United States

Full record on ClinicalTrials.gov

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