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Bendamustine Hydrochloride in Treating Patients With Recurrent or Progressive Anaplastic Glioma | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Bendamustine Hydrochloride in Treating Patients With Recurrent or Progressive Anaplastic Glioma

A Phase II Study of Bendamustine in the Treatment of Recurrent High-Grade Gliomas (Anaplastic Gliomas and Glioblastoma)

NCT00823797•University of Washington

View on ClinicalTrials.gov

Summary

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.

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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
+19 more criteria

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

Locations (3)

Northwestern University

Chicago, Illinois, United States

Huntsman Cancer Institute/University of Utah

Salt Lake City, Utah, United States

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, United States

Key Dates

Start Date

October 1, 2008

Primary Completion Date

December 1, 2015

Completion Date

April 1, 2017

Last Updated

July 7, 2017

Enrollment

ACTUAL participants

Conditions

Adult Anaplastic AstrocytomaAdult Anaplastic OligodendrogliomaAdult Giant Cell GlioblastomaAdult GlioblastomaAdult GliosarcomaRecurrent Adult Brain Neoplasm

Interventions

Bendamustine Hydrochloride

DRUG

Quality-of-Life Assessment

OTHER

NovoTTF-100A With Bevacizumab (Avastin) in Patients With Recurrent Glioblastoma

NCT01894061

Adult Giant Cell GlioblastomaAdult Glioblastoma+2 more

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COMPLETEDPHASE2

Bevacizumab With or Without Radiation Therapy in Treating Patients With Recurrent Glioblastoma

NCT01730950

Adult Giant Cell GlioblastomaAdult Glioblastoma+2 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 7, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Bendamustine Hydrochloride in Treating Patients With Recurrent or Progressive Anaplastic Glioma

Inclusion Criteria

Exclusion Criteria

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