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SARC033 (NCI #10015) IS NOW OPEN FOR ACCRUAL!

FAQs for P10015, SARC033 – Phase II trial of trametinib in patients with unresectable or metastatic epithelioid hemangioendothelioma (EHE).

  1. Is there a point at which trametinib will be determined to be ineffective and the patient offered another therapeutic option? Trametinib treatment may be continued unless there is evidence on CT or MRI scans of significant tumor growth, the occurrence of adverse effects from trametinib on the patient’s health that are intolerable or puts the patient at increased risk of a serious complication from treatment, the treating doctor feels that the patient is not benefiting from the treatment, or the patient wants to stop the treatment.
  2. What is RECIST criteria? RECIST (Response Evaluation Criteria in Solid Tumors) is a commonly used standard to determine whether a patient’s tumor(s) is responding to therapy. Based on the change in the size of tumor(s) measured on CT, MRI or other radiology studies, physicians use RECIST to classify tumor response into different categories e.g. tumor is unchanged in size (stable),  tumor is shrinking (partial response), tumor has disappeared (complete response), or tumor is growing (progression).
  3. Are biopsies part of this clinical trial? Biopsies may be performed to obtain tumor tissue for research during the trial. Please speak with a study doctor about the timing of biopsies, the type of biopsies and risks from biopsies.
  4. Does it matter how long ago the diagnostic biopsy was taken? It does not matter how long ago your initial diagnostic biopsy was taken that established a diagnosis of EHE as long as we can review the specimen to be sure that you have EHE. As part of the review, the biopsy material will be tested for theWWTR1(TAZ)-CAMTA1 fusion gene.
  5. If my tissue was reviewed by Dr Rubin, can it still be used for this trial? Yes! If you previously gave permission to Dr. Rubin to keep your tumor tissue and he has your tissue in his files, he can access it from his files for review. In instances where the tissue has been returned to the local hospital he may need to ask for the tissue to be sent to him again so that he can test the tumor for the WWTR1(TAZ)-CAMTA1 fusion gene.
  6. What are the most common side effects related to trametinib?  Rash, diarrhea, and swelling in arms and/or legs are the most common side effects from trametinib. There is a long list of possible side effects that may be found at www.fda.gov and searching under the drugs tab. Some of the side effects may be serious. Please speak with your doctor (oncologist) or study doctor about possible side effects from trametinib.
  7. Can I participate in a trial with my local doctor? In order to be treated in the clinical trial of trametinib, you must enroll and be treated at one of many designated approved oncology centers involved in this clinical trial. Please contact SARC at sarctrials.org to find the nearest center to you. For more information you can call or email SARC (sarc@sarctrials.org or 734-930-7600).  This trial is also listed at the NCI website: https://clinicaltrials.gov/ct2/show/NCT03148275
  8. Can patients from outside US participate? Patients from outside the US may participate in the trial but they must be evaluated, enrolled and treated by one of the approved oncology centers for this trial. Currently, only centers in the US are approved to conduct this trial.
  9. If my local doctor cannot participate in the trial and I have to travel for therapy, can I still have scans and blood performed locally? Routine blood work and medical care may be provided by your local doctor. Study-specific research tests will need to be done at one of the approved centers for the study. You may be able to have CT, MRI or other scans performed locally if the study doctor is able to obtain the necessary information and images in order to conduct the study according to the approved study protocol. Please discuss with the study doctor the tests that will need to be performed at the study center and the tests that may be performed by your local medical facility.