drugset / Trial / NCT00397501

BBBD Followed By Methotrexate and Carboplatin With or Without Trastuzumab in Treating Women With Breast Cancer That Has Spread to the Brain

NCT00397501

Non-randomizedParallel-groupOpen-labelTreatment

Summary

RATIONALE: Osmotic blood-brain barrier disruption uses certain drugs, such as mannitol, to open the blood vessels around the brain and allow tumor-killing substances to be carried directly to the brain. Drugs used in chemotherapy, such as methotrexate and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Trastuzumab may also help methotrexate and carboplatin work better by making tumor cells more sensitive to the drugs. Giving osmotic blood-brain barrier disruption together with methotrexate, carboplatin, and trastuzumab may kill more tumor cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of carboplatin when given together with methotrexate and trastuzumab after mannitol in treating women with breast cancer that has spread to the brain.

Timeline

Start
2013-10
Primary completion
2013-10
Completion
2013-10

Drugs

EvaluationDrugModalityDoseRoute
Comparator Carboplatin Small molecule 200 mg/m2 Other
Comparator Methotrexate Small molecule 2500 mg Other
Comparator Trastuzumab Monoclonal antibody 2 mg/kg Intravenous
Comparator Sodium Thiosulfate Diagnostic / imaging agent 16 g Intravenous
Comparator Sodium Thiosulfate Diagnostic / imaging agent 20 g Intravenous