The clinical trial is a phase 1, single-arm trial that will evaluate the safety of the investigational treatment on metastatic cancer in patients who have a deleterious or suspected deleterious BRCA1, BRCA2, or PALB2 genetic alteration. The investigational treatment will involve 2 cycles of a combination of intravenous melphalan, BCNU, low-dose I.V. ethanol, vitamin B12b, and vitamin C in association with autologous hematopoietic stem cell infusion. A dose-escalation schedule will be employed for vitamin C.
Pancreatic Adenocarcinoma Metastatic, BRCA1 Mutation, BRCA2 Mutation, Pancreatic Acinar Cell Carcinoma, Pancreatic Ductal Adenocarcinoma, Pancreatic Cancer, Metastatic Pancreatic Cancer, Metastatic Pancreatic Ductal Adenocarcinoma, Breast Cancer Metastatic, Breast Cancer Stage IV, Pancreatic Cancer Stage IV, HER2-negative Breast Cancer, HER2 Negative Breast Carcinoma, Adenocarcinoma of the Breast, PALB2 Gene Mutation
The clinical trial is a phase 1, single-arm trial that will evaluate the safety of the investigational treatment on metastatic cancer in patients who have a deleterious or suspected deleterious BRCA1, BRCA2, or PALB2 genetic alteration. The investigational treatment will involve 2 cycles of a combination of intravenous melphalan, BCNU, low-dose I.V. ethanol, vitamin B12b, and vitamin C in association with autologous hematopoietic stem cell infusion. A dose-escalation schedule will be employed for vitamin C.
SHARON: A Clinical Trial for Metastatic Cancer With a BRCA or PALB2 Mutation Using Chemotherapy and Patients' Own Stem Cells
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Massachusetts General Hospital, Boston, Massachusetts, United States, 02114
Memorial Sloan Kettering Cancer Center, New York, New York, United States, 10065
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
For general information about clinical research, read Learn About Studies.
18 Years to
ALL
No
General Oncology, Inc.,
Arnold Glazier, M.D., STUDY_DIRECTOR, General Oncology, Inc.
2025-12