Phase II Trial of Chemotherapy With Temozolomide in Combination With Topotecan for Central Nervous System (CNS) Metastasis of Solid Tumors
The long-term objective of this research project is to develop chemotherapy-based approach
to the treatment of brain metastases. The specific purpose of this study is to obtain data
on safety and efficacy of combination chemotherapy with temozolomide and topotecan in
patients with central nervous system (CNS) metastases of solid tumors. Patients with brain
metastases of solid tumors have a poor prognosis, despite improvements in survival achieved
with modern neurosurgical and radiation techniques. Chemotherapy does not play any
significant role in this disease, but may have application in salvage of patients who have
failed radiation therapy. In patients who are not surgical candidates, do not require
immediate XRT to relieve symptoms and have controlled systemic disease, effective
chemotherapy as an alternative to XRT might decrease the risk of radiation induced
neurotoxicity.
Recent advances in treatment of systemic disease with the use of modern chemotherapy and
pathobiologic agents have significantly improved overall survival of cancer patients,
putting them at risk for CNS metastases and radiation induced neurotoxicity. Both,
temozolomide and topotecan have good blood-brain barrier penetration and have shown activity
in CNS malignancies. Preclinical studies suggest synergy of this drug combination. This is a
single-arm, open-label phase II drug study. All patients will receive the chemotherapy
combination. Up to 35 patients will be accrued over 2-3 years and followed for up to 5
years. Patients will receive up to 8 cycles of chemotherapy. The primary endpoint is the
rate of radiologic response of brain metastases and secondary endpoints are median overall
survival, progression-free survival, time to progression of brain metastases and toxicity.
The study is expected to provide data to be used in generating further research hypotheses.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Radiologic Response
The primary objective of this study is to determine the overall rate of radiologic response of brain metastases to combination chemotherapy with temozolomide and topotecan in patients with CNS metastases of solid tumors
5 years
Yes
Pamela Z New, M.D.
Principal Investigator
Methodist Neurological Institute
United States: Food and Drug Administration
P05200
NCT01736800
March 2007
Name | Location |
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Methodist Neurological Institute - Department of Neurosurgery | Houston, Texas 77030 |