Clinical Trial Participants Needed

BY CJ Corneliussen-James

BRAIN METS TRIAL NOW OPEN AT THE NCI – 98 APPLICANTS URGENTLY NEEDED. Applications being taken for the next six weeks only. Date this is being posted: March 7, 2018.

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 previously treated with stereotactic surgery or surgical resection.

QUALIFICATIONS:

  • Must be HER+. (ER and PR status can be positive or negative.)
  • Must have diagnosis of brain metastasis.
  • Must have no more than three brain mets or have had brain mets recently removed. (Those with 4 to 5 lesions might be considered.)
  • Must have just had or be eligible for stereotactic radiosurgery or surgical resection of brain mets. (If lesions are present, removal can be done at NCI.)

DISQUALIFIERS:

  • Patients with leptomeningeal metastatic disease
  • Patients with history of WBRT
  • Patients unable to complete a brain MRI with contrast
  • Patients with breast tissue expanders unless removed pre-enrollment
  • HBV, HCV or HIV-positive patients

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

  • Medical history
  • Physical exam
  • Heart tests
  • CT and MRI scans

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.

If you are coming to Bethesda and wish to get together with the Maryland METAvivor peer-to-peer support group, please contact CJ at cj@metavivor.org or Kelly at kelly@metavivor.org

FOR MORE INFORMATION CALL:
Office of Patient Recruitment
1-866-444-1132
TTY: 1-866-411-1010
Online, https://go.usa.gov/xRhAy
Refer to study # 17-C-0115



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