Brain Metastases Clinical Trial
Official title:
Phase II Trial of Chemotherapy With Temozolomide in Combination With Topotecan for Central Nervous System (CNS) Metastasis of Solid Tumors
The specific purpose of this study is to obtain data on safety and efficacy of combination chemotherapy with Temozolomide and Topotecan in patients with CNS metastases of solid tumors. Up to 35 patients will be accrued over 2-3 years and followed for up to 5 years and will receive 8 cycles of chemotherapy. The primary endpoint is the determinant median overall survival and progression-free survival of this regimen, time to progression of the brain metastases, and assessment of toxicity levels in this regimen.
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.
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