Temozolomide Chronotherapy for High Grade Glioma
| Status: | Recruiting |
|---|---|
| Conditions: | Brain Cancer, Brain Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 11/24/2018 |
| Start Date: | August 11, 2016 |
| End Date: | August 31, 2020 |
| Contact: | Jian Campian, M.D., Ph.D. |
| Email: | campian.jian@wustl.edu |
| Phone: | (314) 747-4241 |
A Randomized Feasibility Study Evaluating Temozolomide Chronotherapy for High Grade Glioma
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
invesitgators hypothesize that the timing of TMZ treatment will alter its efficacy and
toxicity.
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
invesitgators hypothesize that the timing of TMZ treatment will alter its efficacy and
toxicity.
Inclusion Criteria:
- 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
Exclusion Criteria:.
-Pregnant and/or breastfeeding. Women of childbearing potential must have a negative
pregnancy test within 14 days of study entry.
We found this trial at
1
site
660 S Euclid Ave
Saint Louis, Missouri 63110
Saint Louis, Missouri 63110
(314) 362-5000
Principal Investigator: Jian Campian, M.D., Ph.D.
Phone: 314-747-4241
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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