A Phase I/II trial in the U.S. for women with Her2 positive breast cancer metastasized to the meninges--the fluid that surrounds the spinal chord and brain where breast cancer cells can metastasize and form tumors. Herceptin is delivered directly into the meninges either intrathecally into the brain or by lumbar puncture into the fluid surrounding the spinal cord. For a description of intrathecal infusion, see the treatments section onleptomeningeal disease. The Herceptin is delivered in combination with whole brain radiation therapy. This is a dosing and safety study. Increasing doses will be assigned at 10, 20, 30, and 40mg. Each dosing group will start at loading dose of a twice weekly dose for a 4 week period which is reduced to a once a week dose for 4 weeks and then a dose every 2 weeks for 4 more weeks. See the bibliography for case studies for cases where off-label use of this experimental treatment has been effective, although the proper dose has not yet been established.
A French Phase l/ll Trial of Herceptin delivered intrathecally or intraventricularly into the meninges, the fluid surrounding the spinal cord and brain where breast cancer cells can metastasize and form tumors. In intrathecal delivery, the Herceptin is delivered directly into the brain. Intraventricular delivery is directly into the fluid surrounding the spine. For a more detailed description of intrathecal infusion, see the treatments section on leptomeningeal disease. This trial allows women with untreated asymtomatic brain metastases or stable brain metastases after treatment. This dosing and safety study assigns patients to doses starting at 30 mg weekly and going up to 150mg weekly. See thebibliography for case studies that have shown that off label use of this experimental treatment can be effective in some cases, although the proper dose has not yet been established.
This is a phase ll trial looking at the efficacy of bevacizumab (Avastin), a drug that blocks the growth of blood vessels into the tumor hoping to starve it of nutrients so that it can't continue to grow. Carboplatin is a chemotherapy that is approved for ovarian cancer and has shown efficacy in breast cancer and in brain metastases. For women with HER2-positive breast cancer, Herceptin will be added to the two drug combination. This trial is opened with newly diagnosed women with breast cancer brain metastases as well as brain metastases that are progressing. This trial also includes women with brain metastases and leptomeningeal disease but not leptomenigeal disease alone.
A Phase I/II trial of Herceptin injected directly into the brain spinal fluid for women found to have cancer cells in their spinal fluid. Must be HER2-positive with stable disease. For a description of intrathecal infusion, see the treatments section on leptomeningeal disease. The intrathecal Herceptin is given in combination with whole brain radiation therapy.
This is phase I/II trial to look at how Avastin may effect cancer that has spread to the brain or spinal fluid. Safety is also being ascertained. If you have been on Avastin in the past you must be off of it six months before entering this trial. You also must be at least one month out from whole brain radiation.
This is a single arm pilot study of intrathecal administration of cytarabine (chemotherapy agent) with systemic oral sorafenib for neoplastic meningitis (leptomeningeal disease) from solid tumors (breast cancer is a solid tumor). Sorafenib targets inhibits the growth of blood vessels into the tumor with the aim of cutting off its blood supply. For a description of intrathecal infusion, see the treatments section on leptomeningeal disease.
The purpose of this phase l randomized study is to demonstrate the safety of giving Whole Brain Radiotherapy (WBRT) together with intrathecal liposomal cytarabine (DepoCyteï¿½) for patients with leptomeningeal metastases. The study will compare the safety of giving this chemotherapy drug at the same time as WBRT with giving the drug after whole-brain radiation is completed. Women who have already had WBRT or brain metastases more than 3 cm diameter are not eligible for this study.
The purpose of this phase II trial is to see how well giving high-dose methotrexate together with liposomal cytarabine works in treating patients with CNS metastases (leptomeningeal and/or brain metastases. For a description of intrathecal infusion, see the treatments section on leptomeningeal disease.
The purpose of this trial is to see if finding leptomeningeal metastases in patients early (before they have symptoms) means women will live longer. The study will be comparing MRI done once every four months versus once a year. This trial is only open to people with Her-2 positive breast cancer that is responding to Herceptin.
This study will try to determine what levels of CA 15-3 (a marker for breast cancer) will predict for leptomeningeal metastases. The cerebrospinal fluid will be obtained intrathecally (For a description of intrathecal infusion, see the treatments section on leptomeningeal disease). Persons must have symptoms of leptomeningeal metastases and this experimental procedure will be followed by an MRI.
The purpose of this phase I trial is to find the right dose of pemetrexed disodium, which is a chemotherapy drug, and to assess its safety and anti-tumor effects. Patients must undergo frequent lumbar punctures. This drug is already used for the treatment of lung cancer.
This phase II trial is studying how well Epothilone B works in treating patients with leptomeningeal metastases. This experimental agent has been shown to cross the blood-brain barrier.
This phase I trial is to determine the side-effects and dose for using radiolabeled antibody therapy in treating advanced CNS or leptomeningeal disease. A radiolabeled monoclonal antibody (8H9) can locate tumor cells and deliver a tumor killing substance which in this case is radioactive iodine 131. The treatment is delivered intrathecally (For a description of intrathecal infusion, see the treatments section on leptomeningeal disease). This trial is not primarily for patients with breast cancer but they can enroll if their tumor has 8H9 antibodies.
The purpose of this phase ll trial is to investigate the efficacy of bevacizumab (Avastin) in combination with two chemotherapies etoposide and cisplatin. Available only in Taiwan.