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SHARON: A Clinical Trial for Metastatic Cancer With an Inherited BRCA or PALB2 Mutation Using Chemotherapy and Patients’ Own Stem Cells

https://www.facingourrisk.org/research-clinical-trials/study/117/sharon-a-clinical-trial-for-metastatic-cancer-with-an-inherited-brca-or-palb2-mutation-using-chemotherapy-and-patients-own-stem-cells

Clinicaltrials.gov identifier:
NCT04150042 (https://clinicaltrials.gov/show/NCT04150042)

Treatment
Advanced pancreatic cancer or stage 4 breast cancer in people with a BRCA1 or BRCA2 mutation

Study Contact Information:

For more information, please contact the Study Sponsor, General Oncology, at 818-4-SHARON (818.474.2766) or [email protected].


About the Study

The purpose of this study is to see whether the combination of melphalan, BCNU, vitamin B12b, and vitamin C, followed by autologous (self) bone marrow stem cell infusion, is safe and effective for treating patients with advanced pancreatic cancer or Stage IV, HER2-negative breast cancer who have a BRCA1, BRCA2 or PALB2 inherited mutation. All of these treatments are given intravenously (by vein).

Melphalan and BCNU are both chemotherapy drugs that work by targeting the processes that cancer cells use to grow and spread. Vitamin B12b and vitamin C work together to block cancer cell energy production and prevent cancer cells from repairing the damage caused by the chemotherapy drugs. Autologous bone marrow stem cell infusion involves using healthy blood-forming cells from a patient's own body to replace diseased or damaged bone marrow. The stem cell infusions will help decrease the side effects of the study treatment. This study is open to people who have already received a PARP inhibitor, as well as those who have not. There is no restriction on how many prior lines of treatment a patient has received before enrolling.

You can learn more on the study website at: www.SharonTrial.com

What the Study Entails

After you finish your second study treatment, the study doctor will continue to follow your condition for 1 year and watch you for side effects. The study doctor or a member of the study team will call you monthly to check if you are having any side effects, and you will come to the clinic 1, 3, 6, 9, and 12 months after your second study treatment.

Sites

New York
New York City, NY: Memorial Sloan Kettering Cancer Center 
Lead researcher: Dr. Kenneth Yu


This Study is Open To:

People 18 years or older may be eligible if they:

This Study is Not Open To:

The study is not open to people who:


About FORCE

FORCE is a national nonprofit organization, established in 1999. Our mission is to improve the lives of individuals and families affected by adult hereditary cancers.