Tumor Resection and Gliadel® Wafers, Followed by Temodar® With Standard Radiation or GammaKnife® for New GBM

• Status: Unknown status
• Trial end date: 2017-12-01
• Target enrollment: 0
• Participant gender: All

Summary

A glioblastoma (GBM) is the most common malignant primary brain tumor, yet it is not easy to control. Recent studies show that survival improves for patients who get aggressive surgery to remove a tumor before starting radiation (RT) and chemotherapy (chemo) treatment. Surgery, RT and chemo are part of regular cancer care for GBM. RT is usually done in daily doses 5 days a week over about 6 weeks. Beams of radiation are aimed at the tumor site plus some of the normal brain tissue around the tumor area. GammaKnife® (GK) radiosurgery also delivers radiation but in a larger dose over one day. GK sends beams to a precise target (tumor location) and very little normal brain tissue that is nearby. This study will compare GK treatment to the usual RT treatment after surgery, and with chemo.

We want to know:

• How well each treatment keeps the tumor from growing back.

• What the effects (good and bad) of the treatments are.

• How you rate your quality of life.

• How the treatment affects your ability to think, understand, reason, and remember.

• How you rate your ability to think, understand, reason, and remember.

• If using a certain type of MRI scan can show the difference between new tumor growth and changes caused by treatment.

• If certain features found in tumor cells can help doctors predict how tumors will respond to treatment.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: St. Joseph's Hospital and Medical Center, Phoenix
• Treatments: Carmustine; Dacarbazine; Temozolomide

Criteria

Inclusion Criteria:

• single enhancing lesion of the brain with MRI appearance consistent with GBM

• Must be appropriate for Gliadel® wafer implant

• Pathologic confirmation of GBM

• no gross residual tumor found on the immediate postoperative MRI scan

• Volumetric measurements of the resection cavity margin being < 50 cc

• Karnofsky performance status (KPS) 80% or better

• Must be able to undergo MRI imaging with gadolinium

• Willingness to have follow up visits at Barrow Neurological Institute(BNI)

Exclusion Criteria:

• multi-focal tumors

• tumors which extend across the corpus callosum,

• residual nodular disease

• Tumors, with a contraindication to Gliadel® implant, such as an anticipated extensive ventricular opening resulting from complete resection.

• Tumor measuring greater than 50cc in volume (on post-operative scan) Volume < 50 cc if volume if a significant volume of eloquent tissue is included in the proposed treatment volume

• Unable to undergo MRI with gadolinium

• History of cancer within 2 years of GBM diagnosis (basal and squamous cell skin cancers are allowed)

• Patient is not willing to follow up at BNI