Temozolomide Chronotherapy in Treating Patients with High Grade Glioma
- Newly diagnosed and recurrent high grade gliomas (World Health Organization [WHO] grades III & IV) and high risk WHO grade II gliomas who are to begin treatment with monthly high dose temozolomide therapy
- Karnofsky performance status >= 60%
- Ability to understand and willingness to sign an Institutional Review Board (IRB) approved written informed consent document
- Pregnant and/or breastfeeding; women of childbearing potential must have a negative pregnancy test within 14 days of study entry
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.
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.
Trial Phase Phase II
Trial Type Treatment
Siteman Cancer Center at Washington University
Jian Li Campian
- Primary ID 201605081
- Secondary IDs NCI-2016-00763
- Clinicaltrials.gov ID NCT02781792