Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study Bendamustine Concurrent Whole Brain Radiation Brain Metastases From Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00879073
Recruitment Status : Terminated (Principal Investigator is leaving Moffitt)
First Posted : April 9, 2009
Last Update Posted : December 18, 2012
Sponsor:
Collaborators:
National Comprehensive Cancer Network
Cephalon
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute

Tracking Information
First Submitted Date  ICMJE April 8, 2009
First Posted Date  ICMJE April 9, 2009
Last Update Posted Date December 18, 2012
Study Start Date  ICMJE April 2009
Actual Primary Completion Date November 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 20, 2011)
Maximum Tolerated Dose (MTD) [ Time Frame: 24 Weeks per Patient ]
To determine the MTD of bendamustine in combination with WBRT
Original Primary Outcome Measures  ICMJE
 (submitted: April 8, 2009)
The primary objective is to determine the toxicity profile and MTD of bendamustine in combination with WBRT. [ Time Frame: 24 Weeks per Patient ]
Change History Complete list of historical versions of study NCT00879073 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 20, 2011)
Number of Participants With Adverse Events (AEs) [ Time Frame: 24 Weeks per Patient ]
To determine the toxicity profile of bendamustine in combination with WBRT
Original Secondary Outcome Measures  ICMJE
 (submitted: April 8, 2009)
  • Determine the plasma pharmacokinetics (PK) of bendamustine in study patients. [ Time Frame: 24 Weeks per Patient ]
  • Determine the presence of bendamustine in cerebrospinal fluid (CSF) of study patients. [ Time Frame: 24 Weeks per Patient ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study Bendamustine Concurrent Whole Brain Radiation Brain Metastases From Solid Tumors
Official Title  ICMJE Phase I Study of Bendamustine With Concurrent Whole Brain Radiation Therapy in Patients With Brain Metastases From Solid Tumors
Brief Summary

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.
Detailed Description

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 CSF.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Brain Metastases
Intervention  ICMJE Drug: Bendamustine
Approximately 15-24 study patients will be enrolled in this Phase I trial. Study patients will receive a weekly dose of IV bendamustine with whole brain radiation therapy for 3 weeks and then receive a fourth dose of IV bendamustine one week after completion of whole brain radiation therapy. The first dose of IV bendamustine will be given when whole brain radiation is initiated.
Other Name: Treanda
Study Arms  ICMJE
  • Experimental: A - Cohort 1 Treatment
    Cohort 1: Bendamustine 60 mg/m² x 4 weeks
    Intervention: Drug: Bendamustine
  • Experimental: B - Cohort 2 Treatment
    Cohort 2: Bendamustine 80 mg/m² x 4 weeks
    Intervention: Drug: Bendamustine
  • Experimental: C - Cohort 3 Treatment
    Cohort 3: Bendamustine 100 mg/m² x 4 weeks
    Intervention: Drug: Bendamustine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: December 17, 2012)
12
Original Estimated Enrollment  ICMJE
 (submitted: April 8, 2009)
24
Actual Study Completion Date  ICMJE December 2012
Actual Primary Completion Date November 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 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

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 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00879073
Other Study ID Numbers  ICMJE MCC-15690
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party H. Lee Moffitt Cancer Center and Research Institute
Study Sponsor  ICMJE H. Lee Moffitt Cancer Center and Research Institute
Collaborators  ICMJE
  • National Comprehensive Cancer Network
  • Cephalon
Investigators  ICMJE
Principal Investigator: Edward Pan, M.D. H. Lee Moffitt Cancer Center and Research Institute
PRS Account H. Lee Moffitt Cancer Center and Research Institute
Verification Date December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP