Ignite Creation Date:
2024-05-05 @ 5:00 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00362817
Status:
COMPLETED
Last Update Posted:
2017-06-01
First Post:
2006-08-08
Brief Title:
Carboplatin and Temozolomide Temodar for Recurrent and Symptomatic Residual Brain Metastases
Sponsor:
Ohio State University Comprehensive Cancer Center
Organization:
Ohio State University Comprehensive Cancer Center
Study Overview
Official Title:
Phase III Multicenter Trial of Intra-Arterial Carboplatin and Oral Temozolomide for the Treatment of Recurrent and Symptomatic Residual Brain Metastases
Status:
COMPLETED
Status Verified Date:
2017-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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 carboplatins 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None