Stem Cell Radiotherapy and Temozolomide for Newly Diagnosed High-grade Glioma
Stopped early · Not applicable
Conditions studied: Glioblastoma, Malignant Glioma, Brain Tumors, Anaplastic Astrocytoma
In brief
There are preliminary studies that suggest that radiation therapy to areas of the brain containing cancer stem cells (in addition to the area where the tumor was surgically treated) may help patients with high-grade brain tumors live longer. The purpose of this study is to determine whether the addition of stem-cell radiation therapy to the standard chemoradiation will further improve the outcome. The investigators will collect information about the patient's clinical status, disease control, neurocognitive effects, and quality of life during follow-up in our department. The purpose of the study is to improve the overall survival patients with newly diagnosed malignant brain tumors treated with stem cell radiation therapy and chemotherapy. The investigators will also measure how patients treated with this novel method of radiation therapy do over time in terms of disease control, potential neurocognitive side effects, overall function, and quality of life.
Key facts
- Study ID
- NCT02039778
- Run by
- Beth Israel Medical Center
- People needed
- 4
- Starts
- 2013-12-01
- Expected to finish
- 2015-12-01
- Last updated by the study team
- 2017-06-05
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients with newly diagnosed with high grade glioma (grade 3 or 4) having completed surgery.
- Patients must be ≥ 18 and ≤ 70 years of age;
- WHO/ECOG Performance Status of 2 or less.
- MRI of the brain as delineated above.
- Patients must sign a study-specific informed consent prior to study entry.
You may not qualify if…
- Evidence of brainstem involvement on radiographs;
- Evidence of oligodendroglioma histology.
- Evidence of progressive disease at the time of study entry;
- Evidence of extracranial distant metastatic disease;
- Prior cranial irradiation;
- Patients may not be entered on other studies that have progression free, disease free, or overall survival as a primary endpoint;
- Patients with synchronous or prior malignancy, other than non-melanomatous skin cancer unless disease free greater than 3 years;
- Pregnant women are ineligible as treatment involves unforeseeable risks to the participant and to the embryo or fetus; patients with childbearing potential must practice appropriate contraception.
Where it is running
- Roosevelt Hospital — New York, New York, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.