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Phase I Study of Bendamustine With Concurrent Whole Brain Radiation Therapy in Patients With Brain Metastases From Solid Tumors

Phase 1
18 Years
Not Enrolling
Brain Metastases

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Trial Information

Phase I Study of Bendamustine With Concurrent Whole Brain Radiation Therapy in Patients With Brain Metastases From Solid Tumors

Bendamustine will be started in the first group at a dose of 60 mg/m²; patients in group 2
will be given Bendamustine at a dose of 80 mg/m²; patients in Group 3 will be given
Bendamustine at 100 mg/m². Each cohort will receive Bendamustine once weekly for a total of
4 weeks.

Approximately 3-6 patients enrolled in this study will receive lumbar punctures. Patients
will be told before study enrollment whether they will have a lumbar puncture to withdraw

Inclusion Criteria:

- 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

- 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)

- Complete history and general physical examination within 28 days prior to study entry

Exclusion Criteria:

- 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

- 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum Tolerated Dose (MTD)

Outcome Description:

To determine the MTD of bendamustine in combination with WBRT

Outcome Time Frame:

24 Weeks per Patient

Safety Issue:


Principal Investigator

Edward Pan, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

H. Lee Moffitt Cancer Center and Research Institute


United States: Institutional Review Board

Study ID:




Start Date:

April 2009

Completion Date:

December 2012

Related Keywords:

  • Brain Metastases
  • Brain and Nervous System
  • Neoplasm Metastasis
  • Neoplasms, Second Primary
  • Brain Neoplasms



H. Lee Moffitt Cancer Center & Research Institute Tampa, Florida  33612