A071601 Phase II trial of BRAF/MEK inhibitors in papillary craniopharyngiomas
Johns Hopkins Kimmel Cancer Center in Baltimore
The purpose of this study is to test any good and bad effects of the study drugs called vemurafenib and cobimetinib.
Patients may be eligible if they have a craniopharyngioma which has recurred (came back), gotten bigger or has residual tumor after surgery.
This study has two groups. All study participants in each group will get vemurafenib and cobimetinib. • Group 1: Patients who have a new diagnosis (i.e. surgery may have been performed, but no other therapy has been given) will be assigned to Group 1. Patients in Group 1 will receive 4-5 cycles of the study drugs and then go on to have radiation therapy and/or surgery depending on how their tumor responded to the treatment. If the tumor responded very well to the study drugs (also known as complete response), then the patient will go on to receive radiation therapy. If the tumor did not respond as well (i.e. did not show a complete response), then the patient and doctor will decide whether continue on to radiation, surgery or both.• Group 2: Patients who have a previous diagnosis and received prior treatment (i.e. surgery, radiation, chemotherapy, etc.) will receive 4 cycles of study drugs. After four cycles of treatment, the patient and doctor will decide what further treatment the patient will receive. The patient may choose to continue to receive more study drugs until their tumor gets worse or comes back. A “cycle” is 28 days of treatment. You will take vemurafenib two times a day for 28 days. You will take cobimetinib for 21 days, then you will not take it for 7 days.If you are in Group 1 (no prior treatment, except surgery), you will receive the study drugs (vemurafenib and cobimetinib) for a total of 4 to 5 cycles. Each cycle is 28 days long. If you are in Group 2 (you have had previous treatment), you will receive the study drugs (vemurafenib and cobimetinib) for at least 4 to 5 cycles, then it is up to you and your doctor whether you would like to continue to receive the study drugs. You can receive the study drugs as long as you do not have severe side effects or until your tumor grows. After you finish (or discontinue) taking the medication, your doctor will continue to watch you for side effects and follow your condition for 5 years from the date you enrolled on the study.
12/14/2019 05:03 AM