Bendamustine Hydrochloride in Treating Patients With Recurrent or Progressive Anaplastic Glioma

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by University of Washington
Sponsor:
Collaborators:
National Comprehensive Cancer Network
Information provided by (Responsible Party):
University of Washington
ClinicalTrials.gov Identifier:
NCT00823797
First received: January 15, 2009
Last updated: August 18, 2014
Last verified: August 2014
  Purpose

This phase II trial studies how well bendamustine hydrochloride works in treating patients with anaplastic glioma or glioblastoma that has come back (recurrent) or growing, spreading or getting worse (progressive). Drugs used in chemotherapy, such as bendamustine hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.


Condition Intervention Phase
Adult Anaplastic Astrocytoma
Adult Anaplastic Oligodendroglioma
Adult Giant Cell Glioblastoma
Adult Glioblastoma
Adult Gliosarcoma
Recurrent Adult Brain Tumor
Drug: bendamustine hydrochloride
Other: quality-of-life assessment
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Bendamustine in the Treatment of Recurrent High-Grade Gliomas (Anaplastic Gliomas and Glioblastoma)

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • PFS [ Time Frame: At 6 months ] [ Designated as safety issue: No ]
    Defined as the proportion of patients who remain alive and free of any disease progression at 6 months. PFS over time will be estimated using the Kaplan-Meier method with standard errors estimated using Greenwood's formula.


Secondary Outcome Measures:
  • Best overall response [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
  • PFS [ Time Frame: At 6 months ] [ Designated as safety issue: No ]
    Defined as the time from date of initial therapy to first objective documentation of tumor progression or death. PFS over time will be estimated using the Kaplan-Meier method with standard errors estimated using Greenwood's formula.

  • Toxicity that results in significant reduction in or cessation of bendamustine hydrochloride treatment [ Time Frame: Up to 30 days after completion of study treatment ] [ Designated as safety issue: Yes ]
    All reported adverse events will be coded using the Cancer Therapy Evaluation Program Common Toxicity Criteria. The number and percent of subjects reporting adverse events (all, severe or worse, serious and related) will be quantified.

  • Toxic death [ Time Frame: Up to 30 days after completion of study treatment ] [ Designated as safety issue: Yes ]
    Defined as death that is possibly, probably, or definitely attributed to bendamustine hydrochloride.

  • Quality of life, assessed by the FACT-BR total score [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
    FACT-BR total score trajectories will be examined for each patient, and for groups defined by length of follow-up. Quality of life data will be used to quantify the impact of adverse events on patient quality of life.


Estimated Enrollment: 61
Study Start Date: October 2008
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment (bendamustine hydrochloride)
Patients receive bendamustine hydrochloride IV over 30-90 minutes on days 1-2. Treatment repeats every 28 days for at least 6 courses in the absence of disease progression or unacceptable toxicity.
Drug: bendamustine hydrochloride
Given IV
Other Names:
  • bendamustin hydrochloride
  • bendamustine
  • cytostasan hydrochloride
  • Treanda
Other: quality-of-life assessment
Ancillary studies
Other Name: quality of life assessment

Detailed Description:

PRIMARY OBJECTIVES:

I. The primary endpoint for this study is the 6-month progression-free survival-i.e., the proportion of patients who remain alive and free of any tumor progression at 6 months.

SECONDARY OBJECTIVES:

I. To determine the safety of single agent bendamustine (Treanda) (bendamustine hydrochloride) the treatment of malignant gliomas.

II. To determine the efficacy of bendamustine (Treanda) as a single agent as assessed by progression-free survival (PFS) at 6 months.

III. To assess quality of life using the Functional Assessment of Cancer Therapy-Brain (FACT-BR).

OUTLINE:

Patients receive bendamustine hydrochloride intravenously (IV) over 30-90 minutes on days 1-2. Treatment repeats every 28 days for at least 6 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 30 days and then every 2 months for up to 3 years.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All patients must have had prior pathologic confirmation of tumor histology, anaplastic glioma (AG) or glioblastoma (GBM) and have supratentorial gliomas
  • Patients must have shown unequivocal evidence for tumor recurrence or progression by magnetic resonance imaging (MRI) or computed tomography (CT) scan with contrast
  • The recurrence to be treated needs to be the 1st or 2nd recurrence of the AG or GBM
  • If a patient has had surgery prior to enrolling on study, an enhanced MRI or CT scan should be done within 96 hours prior to surgery or at least 4-6 weeks after surgery
  • Patients having undergone recent resection of recurrent or progressive tumor will be eligible as long as all of the following conditions apply:

    • They are > 2 weeks from surgery
    • They have recovered from the effects of surgery
    • Evaluable or measurable disease following resection of recurrent tumor is mandated for eligibility into the study
    • To best assess the extent of residual disease post-operatively, an enhanced CT/MRI should be done no later than 96 hours after surgery or it will need to be done 4-6 weeks post-operatively; if the 96 hour scan is more than 2 weeks from registration, the scan needs to be repeated
  • A baseline scan should be performed within 14 days prior to registration and on a steroid dosage that has been stable for at least 5 days otherwise a new baseline MR/CT is required; the same type of scan, i.e., MRI or CT must be used throughout the period of protocol treatment for tumor measurement
  • Patients must have failed prior external beam radiation therapy; a positron emission tomography (PET) or thallium single photon emission computed tomography (SPECT), MR spectroscopy and MR perfusion, or surgical documentation may be done at the discretion of the treating physician if there is a question of radiation changes/necrosis versus progressive disease
  • Stereotactic radiosurgery (SRS):

    • Patients must have confirmation of true progressive disease rather than radiation necrosis based upon either PET or Thallium SPECT, MR spectroscopy and MR perfusion or surgical documentation of disease
    • At least 12 weeks between completion of SRS and initiation of bendamustine
  • Interstitial brachytherapy: patients must have confirmation of true progressive disease rather than radiation necrosis based upon either PET or Thallium SPECT, MR spectroscopy and MR perfusion or surgical documentation of disease
  • Patients must have had at least one prior chemotherapy regimen that included temozolomide and no more than one prior salvage chemotherapy
  • Patients must have recovered from the toxic effects of prior therapy: 4 weeks from prior cytotoxic therapy and/or at least 2 weeks from vincristine, 6 weeks from nitrosoureas, 3 weeks from procarbazine administration, and 1 week for non-cytotoxic agents, e.g., interferon, tamoxifen, thalidomide, cis-retinoic acid, etc. (radiosensitizer does not count), 4 weeks for experimental biologic agents (epidermal growth factor receptor [EGFR] inhibitors, etc) and 7 weeks from Gliadel implantation
  • All patients must sign an informed consent indicating that they are aware of the investigational nature of this study; patients must sign an authorization for the release of their protected health information
  • Patients must have a life expectancy > 11 weeks
  • Patients must have a Karnofsky performance status of > 60
  • White blood cells (WBC) >= 3,000/ul
  • Absolute neutrophil count (ANC) >= 1,500/mm^3
  • Platelet count >= 80,000/mm^3
  • Hemoglobin >= 9 mg/dl (NOTE: eligibility level for hemoglobin may be reached by transfusion)
  • Absolute lymphocyte count >= 200/mm^3
  • Serum glutamic oxaloacetic transaminase (SGOT)/serum glutamate pyruvate transaminase (SGPT) < 3 times upper limit of normal (ULN)
  • Bilirubin < 1.5 times ULN
  • Serum creatinine < 1.5 mg/dL
  • Calculated creatinine, glomerular filtration rate (GFR) >= 30 cc/minute

Exclusion Criteria:

  • Patients must not have any significant medical illnesses that in the investigator's opinion cannot be adequately controlled with appropriate therapy or would compromise the patient's ability to tolerate this therapy
  • Known human immunodeficiency virus (HIV)-positive patients receiving combination anti-retroviral therapy are excluded from the study
  • Patients with a history of any other cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix), unless in complete remission and off of all therapy for that disease for a minimum of 3 years are ineligible
  • Patients must not be pregnant or breast feeding and must practice adequate contraception
  • Patients can only be on non-enzyme inducing anti-convulsants; if they are on an enzyme inducing anti-convulsant, they may be converted to a non-enzyme inducing anticonvulsants
  • Patients cannot be taking any cytochrome P450, cytochrome P450, family 1, subfamily A, polypeptide 2 (CYP1A2) pathway inhibiting or inducing agents (except proton pump inhibitors which are allowed) including cimetidine, antidepressants, antibiotics and all others
  • Known sensitivity to bendamustine
  • Known sensitivity to mannitol
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00823797

Locations
United States, Illinois
Northwestern University Active, not recruiting
Chicago, Illinois, United States, 60611
United States, Utah
Huntsman Cancer Institute/University of Utah Active, not recruiting
Salt Lake City, Utah, United States, 84112
United States, Washington
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium Recruiting
Seattle, Washington, United States, 98109
Contact: Fereshteh Assadian    206-288-6693      
Principal Investigator: Marc C. Chamberlain         
Sponsors and Collaborators
University of Washington
National Comprehensive Cancer Network
Investigators
Principal Investigator: Marc Chamberlain Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
  More Information

No publications provided

Responsible Party: University of Washington
ClinicalTrials.gov Identifier: NCT00823797     History of Changes
Other Study ID Numbers: 6803, NCI-2010-00714, 6803, P30CA015704
Study First Received: January 15, 2009
Last Updated: August 18, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Astrocytoma
Brain Neoplasms
Glioblastoma
Glioma
Oligodendroglioma
Gliosarcoma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Bendamustine
Nitrogen Mustard Compounds
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 20, 2014