Study on Subventricular Zone and Temozolomide Treatment for Glioblastoma Multiforme
Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
ClinicalTrials ID:NCT02177578
This clinical trial is exploring whether a higher dose of radiation to a specific brain area, combined with standard chemotherapy, can better control glioblastoma multiforme, a type of brain cancer, compared to standard treatment.
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Program Overview
In this study, patients with glioblastoma multiforme will receive 6 weeks of radiation therapy along with the chemotherapy drug temozolomide, which is the standard treatment. However, the radiation plan will be adjusted to deliver a higher dose to the subventricular zone, an area in the brain that contains stem cells. Some scientists believe these cells might contribute to the cancer coming back. The study aims to find out if this modified radiation approach can keep the tumor under control for a longer time compared to the usual radiation therapy with temozolomide.
Description
Research suggests that cells in the subventricular zone of the brain might play a role in the recurrence of glioblastoma, a type of brain cancer. Previous studies have shown that patients who received higher doses of radiation to this area might live longer than those who received lower doses. This study will look at how long patients with newly diagnosed glioblastoma can live without the cancer getting worse when treated with temozolomide and a modified radiation plan that targets both the tumor and the subventricular zone, compared to those receiving standard radiation therapy. In this study, 3 out of every 4 patients will receive the modified radiation treatment, while 1 out of every 4 will receive the standard radiation treatment.
Eligibility Criteria
Inclusion Criteria
- Must have a new diagnosis of glioblastoma multiforme (GBM) confirmed by a lab test.
- Must have had surgery to remove the tumor or a biopsy and start radiation within 12 weeks of the procedure.
- Must not have had previous radiation to the brain.
- Must be at least 18 years old.
- Must be in good overall health with a performance status score of 0 to 2.
- Must be scheduled to receive temozolomide during and after radiation.
- Women of childbearing potential must have a negative pregnancy test before treatment and agree to use birth control during the study and for 12 weeks after.
- Must be able to understand and sign a consent form agreeing to participate in the study.
- Radiation therapy must start within 12 weeks of surgery.
Exclusion Criteria
- Cannot have had another cancer, except for certain skin cancers or other cancers that have been disease-free for at least 2 years.
- Cannot have uncontrolled health issues like active infections, heart failure, unstable chest pain, or mental health conditions that would make it hard to follow the study requirements.
- Pregnant or breastfeeding women cannot participate. Women who can become pregnant must agree to use birth control during the study and for 12 weeks after. Men must also agree to use birth control for the same period.
- Cannot have used Avastin or similar drugs before the cancer progresses.
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