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| Sponsor: | Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium |
|---|---|
| Collaborators: |
National Comprehensive Cancer Network National Cancer Institute (NCI) |
| Information provided by: | Fred Hutchinson Cancer Research Center |
| ClinicalTrials.gov Identifier: | NCT00823797 |
Purpose
This phase II trial is studying how well bendamustine hydrochloride works in treating patients with recurrent or progressive anaplastic glioma or glioblastoma multiforme. 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 Recurrent Adult Brain Tumor |
Drug: bendamustine hydrochloride Procedure: 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) |
| Estimated Enrollment: | 61 |
| Study Start Date: | October 2008 |
| Estimated Primary Completion Date: | January 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Treatment (chemotherapy)
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:
Procedure: quality-of-life assessment
Ancillary studies
Other Name: quality of life assessment
|
PRIMARY OBJECTIVES:
I. The primary endpoint for this study is the 6-month progression-free survival (PFS) (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 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 for 30 days and then every 3 months thereafter.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients having undergone recent resection of recurrent or progressive tumor will be eligible as long as all of the following conditions apply:
Stereotactic radiosurgery (SRS):
Exclusion Criteria:
Contacts and Locations| United States, Illinois | |
| Northwestern University | Recruiting |
| Chicago, Illinois, United States, 60611 | |
| Contact: Katie N. McCarthy 312-695-1352 katie-mccarthy@northwestern.edu | |
| Principal Investigator: Sean Grimm | |
| United States, Utah | |
| Huntsman Cancer Institute/University of Utah | Not yet recruiting |
| Salt Lake City, Utah, United States, 84112 | |
| Contact: Travis Ault 801-587-5562 Travis.Ault@hci.utah.edu | |
| Principal Investigator: Howard Colman | |
| United States, Washington | |
| Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | Recruiting |
| Seattle, Washington, United States, 19024-1024 | |
| Contact: Fereshteh Assadian 206-288-6693 | |
| Principal Investigator: Marc C. Chamberlain | |
| Principal Investigator: | Marc Chamberlain | Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium |
More Information
| Responsible Party: | Chamberlain, Marc, Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium |
| ClinicalTrials.gov Identifier: | NCT00823797 History of Changes |
| Other Study ID Numbers: | 6803, NCI-2010-00714 |
| Study First Received: | January 15, 2009 |
| Last Updated: | April 13, 2012 |
| Health Authority: | United States: Institutional Review Board |
|
Astrocytoma Brain Neoplasms Glioma Oligodendroglioma 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 Therapeutic Uses Pharmacologic Actions Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action |