NCT02781792CompletedPhase 2
Temozolomide Chronotherapy for High Grade Glioma
A Randomized Feasibility Study Evaluating Temozolomide Chronotherapy for High Grade Glioma
Source: ClinicalTrials.gov · Last updated 27 Jun 2025
Brief summary (registry, in English)
Temozolomide (TMZ) is the chemotherapy drug approved by the FDA to increase survival in glioblastoma (GBM) patients beyond surgical resection and radiation therapy alone. Give its activity in astrocytomas, TMZ is commonly used in grade III anaplastic astrocytoma (AA) as well. Both grade III AA and grade IV GBM are high grade gliomas (HGG). The short half-life of this drug and known oscillations in DNA damage repair make it an ideal candidate for chronotherapy. Chronotherapy is the improvement of treatment outcomes by minimizing treatment toxicity and maximizing efficacy through delivery of a medication according to the timing of biological rhythms within a patient. Chronotherapy has improved outcomes through the reduction of side effects and increase in anti-tumor activity for a variety of cancers, but has never been applied to the treatment of gliomas. Based on the preliminary preclinical data for chronotherapeutic TMZ treatment of intracranial glioma xenografts and the success of chronotherapy in the treatment of other cancers, the investigators hypothesize that the timing of TMZ treatment will alter its efficacy and toxicity.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 42 (actual)
- First submitted
- 20 May 2016
- Start date
- 11 Aug 2016
- Primary completion date
- 18 Jul 2024
- Lead sponsor
- Washington University School of Medicine
- Diseases
- Glioblastoma
- NCT number
- NCT02781792
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 42
- From 11 Aug 2016 to the primary completion date, 18 Jul 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- -Pregnant and/or breastfeeding. Women of childbearing potential must have a negative pregnancy test within 14 days of study entry.
Who the study is looking for
- Newly diagnosed and recurrent high grade gliomas (WHO grades III \& IV) and high risk WHO grade II gliomas who are to begin treatment with monthly high dose temozolomide therapy.
- Scheduled to receive adjuvant temozolomide therapy after having completed concurrent temozolomide and radiation therapy.
- At least 18 years of age.
- Karnofsky performance status ≥ 60%
- Ability to understand and willingness to sign an IRB approved written informed consent document
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Washington University School of Medicine Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.