Efficacy of Hypofractionated XRT w/Bev. + Temozolomide for Recurrent Gliomas

Conditions

• Adult Anaplastic Astrocytoma
• Adult Anaplastic Ependymoma
• Adult Anaplastic Oligodendroglioma
• Adult Giant Cell Glioblastoma
• Adult Glioblastoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Temozolomide — DRUG
  Given PO
• hypofractionated radiation therapy — RADIATION
  Undergo hypofractionated radiation therapy
• bevacizumab — BIOLOGICAL
  Given IV
• questionnaire administration — OTHER
  Ancillary studies

Study Details

This phase II trial studies how well giving hypofractionated radiation therapy together with temozolomide and bevacizumab works in treating patients with high-grade glioblastoma multiforme or anaplastic glioma. Specialized radiation therapy, such as hypofractionated radiation therapy, that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving hypofractionated radiation therapy together with temozolomide and bevacizumab may kill more tumor cells.

Key Dates

First listed

Nov 23, 2011

Start date

Dec 14, 2011

Status verified

Jul 2019

Primary completion

Sep 12, 2018

Completion

Sep 12, 2018

Study Design

Enrollment

54 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Treatment (radiation, chemotherapy, monoclonal antibody)
  CONCURRENT THERAPY: Patients undergo hypofractionated radiation therapy 5 days a week beginning on day 0. Patients also receive temozolomide PO QD and bevacizumab IV over 30-90 minutes once every 2 weeks beginning on days -3 to 0. Treatment continues for 5 weeks in the absence of disease progression or unacceptable toxicity. ADJUVANT THERAPY: Beginning 2 weeks after completion of radiation therapy, patients receive temozolomide PO QD for 6 weeks and bevacizumab IV over 30-90 minutes once every 2 weeks. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Overall Survival (OS) for Patients With Recurrent High Grade Malignant Gliomas Treated With Concurrent Radiation, Temozolomide, and Bevacizumab Followed by Adjuvant Temozolomide and Bevacizumab. [ Time Frame: From treatment initiation and every 8 weeks for up to 53.5 months ]

Locations (5)

Find similar trials in Chicago, IL

Related Studies

• A Study of RNA-lipid Particle (RNA-LP) Vaccines for Newly Diagnosed Pediatric High-Grade Gliomas (pHGG) and Adult Glioblastoma (GBM)
  PHASE1 · Recruiting · University of Florida · Washington D.C., District of Columbia