Study Bendamustine Concurrent Whole Brain Radiation Brain Metastases From Solid Tumors

NCT00879073 | Terminated Phase 1 DMC

• 1 other identifier: MCC-15690
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Metastases

Keywords

Brain and Nervous System

Outcome Measures

Primary Outcomes (1)

• Maximum Tolerated Dose (MTD)

  To determine the MTD of bendamustine in combination with WBRT

  24 Weeks per Patient

Secondary Outcomes (1)

• Number of Participants With Adverse Events (AEs)

  24 Weeks per Patient

Study Arms (3)

A - Cohort 1 Treatment

EXPERIMENTAL

Cohort 1: Bendamustine 60 mg/m² x 4 weeks

Drug: Bendamustine

B - Cohort 2 Treatment

EXPERIMENTAL

Cohort 2: Bendamustine 80 mg/m² x 4 weeks

Drug: Bendamustine

C - Cohort 3 Treatment

EXPERIMENTAL

Cohort 3: Bendamustine 100 mg/m² x 4 weeks

Drug: Bendamustine

Interventions

Bendamustine DRUG

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.

Also known as: Treanda

A - Cohort 1 Treatment; B - Cohort 2 Treatment; C - Cohort 3 Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• H. Lee Moffitt Cancer Center and Research Institute: lead
• National Comprehensive Cancer Network: collaborator
• Cephalon: collaborator

Study Sites (1)

H. Lee Moffitt Cancer Center & Research Institute

Tampa, Florida, 33612, United States

Location

MeSH Terms

Conditions

Brain Neoplasms; Neurologic Manifestations

Interventions

Bendamustine Hydrochloride

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Edward Pan, M.D.

  H. Lee Moffitt Cancer Center and Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2009
• First Posted: April 9, 2009
• Study Start: April 1, 2009
• Primary Completion: November 1, 2012
• Study Completion: December 1, 2012
• Last Updated: December 18, 2012

Record last verified: 2012-12

Locations

US (1)