BRAIN METS TRIAL NOW OPEN AT THE NCI – APPLICANTS URGENTLY NEEDED.
PURPOSE OF THE TRIAL: To determine if TDM-1 combined with the oral drug Temozolomide, which is known to have the ability to cross the blood brain barrier, can prevent a return of brain metastases that have been recently treated with stereotactic surgery or surgical resection.
TREATMENT: There will be two groups in the trial. One group will receive TDM-1 plus Temozolomide. The other group will receive TDM-1 only. The study will be done in 3-week cycles. All participants will get T-DM1 on day 1 of each cycle. Some participants will also take TMZ capsules by mouth every day. Participants will have image-guided lumbar puncture at least 2 times. Participants will have a follow-up visit about 1 month after stopping the study drug.
SCREENING: Participants will be screened with the following
COST: For those qualifying for the trial, the NCI will cover the cost of the trial and the cost of transportation to and from the NIH Clinical Center in Bethesda MD for purposes of the trial. The NCI will also give a small stipend to help with hotel costs to those participating in the trial. NOTE: Travel to the NCI to determine whether you qualify for the trial must be at personal expense.
LOCATION: All tests and procedures will be performed at the NIH Clinical Center, America’s Research Hospital in Bethesda, Maryland. They are on the Washington DC Metro system. Take the Red Line and get off at the Medical Center stop.
FOR MORE INFORMATION CALL:
Office of Patient Recruitment
Refer to study # 17-C-0115