Brain Tumor Clinical Trial
Official title:
Phase I/II Multicenter Trial of Intra-Arterial Carboplatin and Oral Temozolomide for the Treatment of Recurrent and Symptomatic Residual Brain Metastases.
Purpose: The primary objective of this study is to determine if chemotherapy with carboplatin and temozolomide significantly affects the response rates, or size of disease, in patients with brain metastases, originating from cancer in other parts of the body, compared to patients who have already been treated with radiation. Survival, causes of death, recurrence of disease in the central nervous system, toxicity, and quality of life will all be measured as secondary objective in this study.
Rationale: Surgery and radiation are often used as treatments for brain metastases, or
tumors in the brain that originate from other parts of the body. It is currently unknown
whether patient survival or time to progression would experience additional benefits through
the addition of chemotherapy. Previous research does appear to suggest that a chemotherapy
regimen may improve outcomes of patients with brain metastases previously treated with
radiation. The current study further evaluates this research question by providing patients
with recurrent or symptomatic residual brain metastases with carboplatin and temozolomide,
two chemotherapy agents. Temozolomide has demonstrated clinical antitumor efficacy against
malignant gliomas and has been tested with some efficacy against several other types of
cancer. This drug appears to have less adverse effects compared to other commonly used
cancer drugs. Recent research indicates that temozolomide also has some efficacy against
brain metastases. In addition, previous research indicates carboplatin's lack of severe
toxicity in patients with this disease.
Treatment: Study participants will be treated with carboplatin and temozolomide. Carboplatin
will be administered through intravenous infusions. Temozolomide will be given through oral
pills. Before these drugs are administered, study participants will undergo a pre-treatment
evaluation with physical and neuropsychological examinations, neuro-imaging, laboratory
tests, quality of life assessment, and other procedures. Carboplatin will be given for two
consecutive days. Temozolomide will be taken by study participants daily for five
consecutive days. Both of these treatment schedules will be repeated every 28 days. Several
tests and exams will be given throughout the study to closely monitor patients. Study
treatments will be discontinued due to disease growth or unacceptable adverse events.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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