This phase II trial studies how well temozolomide chronotherapy works in treating patients with high grade glioma. Chronotherapy is the treatment of an illness according to the timing of biological rhythms within a patient. Chemotherapy drugs, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. The time of day that temozolomide is given may reduce side effects and increase anti-tumor activity in patients with high grade glioma.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02781792.
PRIMARY OBJECTIVE:
I. To determine the feasibility of treatment compliance and randomization of high grade glioma (HGG) patients to receive temozolomide between morning (before 10:00) or evening (after 20:00) treatment groups.
SECONDARY OBJECTIVES:
I. To determine the number of HGG patients with grade 3 or 4 hematologic toxicity, including lymphopenia, thrombocytopenia, neutropenia and anemia, while receiving temozolomide when administered in the morning (before 10:00) or evening (after 20:00).
II. To assess quality of life using quality of life surveys in HGG patients receiving temozolomide in the morning versus evening.
III. To evaluate progression-free survival of HGG patients taking temozolomide (TMZ) in the morning versus evening through chart view or patient visits.
IV. To determine overall survival of HGG patients taking TMZ in the morning versus evening through chart review or patient visits.
V. To correlate the sleep-wake cycles of patients receiving temozolomide for treatment of HGG with treatment outcomes for morning versus evening TMZ treatments.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I: Patients receive temozolomide in the morning (before 10:00) on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also wear the ActTrust Condor Instrument watch daily for 24 hours a day.
GROUP II: Patients receive temozolomide in the evening (after 20:00) on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also wear the ActTrust Condor Instrument watch daily for 24 hours a day.
After completion of study treatment, patients are followed up every 6 months for up to 2 years.
Lead OrganizationSiteman Cancer Center at Washington University
Principal InvestigatorMilan Girish Chheda
