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A pilot study to assess safety and feasibility of 5 fraction hypofractionated stereotactic radiosurgery (treating tumor and edema) along with standard temozolomide for newly diagnosed glioblastoma, including assessment of lymphocyte sparing effect.
Protocol Number:
Lawrence Kleinberg
Johns Hopkins Kimmel Cancer Center in Baltimore
Suburban Hospital
Primary Objective: To evaluate whether stereotactic hypofractionated radiotherapy, treating gross contrast enhancing tumor and Flair/edema volume, in combination with standard 6 week temozolomide dosing is safe and feasible.Secondary Objectives: i) To evaluate whether stereotactic hypofractionated radiotherapy in combination with Temozolomide will improve the rate of free grade 3 or higher lymphopenia in patients with malignant glioma at the standard week 10 follow-up. ii) To describe the percent of patients with CD4 count less than 200 mm/m3 at the standard week 10 follow-up. iii) Describe recovery of lymphocyte counts during routine clinical follow-up. iv) To describe survival outcome. v) Characterize imaging outcome. vi) Preserve blood specimens obtained prior to treatment at the week 10 evaluation point for hypothesis generating correlative studies including immunologic studies.
i) Patients must be at least 18 years of age. ii) Patients must have histologically confirmed supratentorial grade IV astrocytoma (glioblastoma multiforme), established by biopsy or resection not more than 3 months prior to registration. iii) Maximum postoperative dimension of cavity plus residual contrast enhancing tumor of less than 6 cm. If a patient is found on the radiation planning scan to have a tumor target larger than this size, the patient will be removed from the study. iv) Patient must be selected for standard temozolomide chemotherapy to be administered with radiotherapy. v) Patient agrees to have 10 week follow-up visit at a participating Johns Hopkins facility. vi) Patient agrees to allow access to or provide clinical, imaging, and laboratory follow-up information for three years whether or not obtained from Johns Hopkins providers. vii) Patients must not have received prior radiation therapy, chemotherapy, immunotherapy or therapy with biologic agents (including immunotoxins, immunoconjugates, antisense, peptide receptor antagonists, interferons, interleukins, TIL, LAK or gene therapy), or hormonal therapy for their brain tumor. Glucocorticoid therapy is allowed. viii) Patients must have a Karnofsky performance status 60 or higher (i.e. the patient must be able to care for himself/herself with occasional help from others). ix) Patients must be able to provide written informed consent. x) Patients with the potential for pregnancy or impregnating their partner must agree to follow acceptable birth control methods to avoid conception. Women of childbearing potential must have a negative pregnancy test. xi) Patients must be able to undergo MRI scan with gadolinium contrast for treatment planning.
In this study, patients will be treated with an alternative radiation regimen including short course stereotactic hypofractionated therapy administered over 5 days rather than the standard six week course. This therapy will target the same volume as is targeted with standard conventionally fractionated radiotherapy. In contrast to other studies testing stereotactic radiosurgery for this illness, the standard of care six week course of temozolomide will be utilized. Before the patient can begin the study, the following exams, tests, and procedures will need to be completed: a history of clinical examination within one week of starting therapy, standard of care pretreatment laboratory tests including CBC with differential and CD4 count within two weeks of starting therapy, additional blood specimens for correlative studies, and MRI imaging for radiation planning and radiotherapy simulation within 3 weeks of starting therapy. If the patient’s contrast enhancement and tumor cavity is greater than 6 cm in size, the patient will be removed from the study and receive standard radiotherapy.Radiotherapy will be given for 5 consecutive weekdays (excluding holidays) and should begin by day 8 of temozolomide. Enrolled patients must be determined by their treatment team to be candidates for and plan to be treated with standard temozolomide administration based on the EORTC “Stupp” trial, and will receive continuous daily temozolomide comprising week 1-6 of therapy. During this time, patients will have weekly labs with CBC with differential at the discretion of the treatment team, clinical evaluations on weeks 1 and 4, and evaluations for toxicity on week four.After the six week therapy treatment, patients will return for a standard week ten follow-up which includes clinical assessments, MRI, and laboratory tests including CBC with differential and CD4 counts. There will also be another blood sample taken to be preserved for correlative studies at this time point. Additional temozolomide after week ten will be at the discretion of the treatment team.Patients who complete the week 10 follow-up will then be scheduled for standard of care follow-up clinical assessments, toxicity assessments, labs, and MRIs at the discretion of the treatment team. These follow ups will typically occur every other month after the first 30 day follow-up visit.
Last Update
12/14/2019 05:03 AM