#T DM1 CLINICAL TRIALS TRIAL#
A minimum interval of 3 weeks between completion of brain SRS and/or resection and the start of treatment in this trial will be observed to allow proper healing.
Patients must have 1-10 brain metastases, by contrast MRI, treated within 12 weeks of study entry with SRS and/or resection. Ability of subject to understand and the willingness to sign a written informed consent document. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Alkylating agents as well as other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control abstinence) prior to study entry, for the duration of study participation and for 7 months (women) or 4 months (men) after treatment completion. creatinine clearance greater than or equal to 60 mL/min/1.73 m(2) for patients with creatinine levels above institutional normal. creatinine up to 1.5 upper institutional limits, OR AST(SGOT)/ALT(SGPT) <3.0 X institutional upper limit of normal total bilirubin within normal institutional limits platelets greater than or equal to 100,000/mcL absolute neutrophil count greater than or equal to 1,000/mcL leukocytes greater than or equal to 3,000/mcL Patients must have normal organ and marrow function as defined below: ECOG performance status less than or equal to 2 (Karnofsky greater than or equal to 60%, see Appendix A) Because breast cancer is not commonly found in pediatric population and no dosing or adverse event data are currently available on the use of temozolomide in combination with T-DM1 in patients <18 years of age, children are excluded from this study, but will be eligible for future pediatric trials. Patients that need increase in dose of corticosteroid after initial month will be taken off protocol treatment. Patients that need to continue corticosteroids after the initial month will be allowed to continue in the protocol treatment if no further increase in dose is necessary. With T-DM1 after SRS, up to a dose of no more than 10mg of dexamethasone daily or equivalent. Corticosteroids will be allowed at enrollment and during the first month of treatment The presence of concomitant extracranial metastatic disease is allowed for enrollment. A minimum interval of 3 weeks between completion of brain SRS and/or resection and 6 weeks for WBRT and the start of treatment in this trial will be observed to allow proper healing. Patients must have brain metastases, treated within 12 weeks of study entry with SRS, resection or WBRT. HER2 testing must have been performed in a laboratory accredited by the College of American Pathologists (CAP) or another accrediting entity. Patients must have histologically confirmed HER2-positive breast cancer for which standard curative measures do not exist or are no longer effective. They will be contacted by telephone or email every 3 months after that. Participants will have a follow-up visit about 1 month after stopping the study drug. Participants will be asked to provide tumor samples when available. This will be done with local anesthesia and with the help of images. A needle is inserted into the spinal canal low in the back and cerebrospinal fluid is collected. Participants will have lumbar puncture at least 2 times. Answer questions about their general well-being and functioning. Participants will keep a medication diary.ĭuring the study, participants will also: Some participants will also take Temozolomide capsules by mouth every day. A scan (MRI) that uses a magnetic field to make an image of the brainĪll participants will get T-DM1 on Day 1 of every cycle through a small plastic tube inserted in an arm vein. A scan (CT) that makes a picture of the body using a small amount of radiation To study if Temozolomide with T-DM1 lowers the chance of having new metastases in the brain.Īdults at least 18 years old with a HER2-positive breast cancer that has spread to the brain and was recently treated with stereotactic radiation or surgery. Researchers want to see if combining it with the drug T-DMI prevents the formation of new metastases in the brain. The drug Temozolomide is approved to treat brain tumors. Researchers want to study new treatments for brain metastases. Sometimes breast cancer spreads (metastasizes) to the brain. Type: No longer recruiting/follow-up only Summary | Eligibility | Citations | Contacts Summary This study is NOT currently recruiting participants. Protocol Details Phase I/II Study of T-DM1 Alone Versus T-DM1 and Metronomic Temozolomide in Secondary Prevention of HER2-Positive Breast Cancer Brain Metastases Following Stereotactic Radiosurgery
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