A Study of Melphalan, BCNU, Vitamin B12b, Vitamin C, and Stem Cell Infusion in People with Advanced Pancreatic Cancer and BRCA Mutations

Share
Print

Full Title

A Phase 1 Trial of Melphalan, BCNU, Hydroxocobalamin, Ascorbic Acid, and Autologous Bone Marrow Stem Cell Infusion in Patients With Pancreatic Cancer and an Inherited BRCA1 or BRCA2 Mutation

Purpose

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 who have a BRCA1 and/or BRCA2 gene 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.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have advanced pancreatic cancer.
  • Patients must have responded to platinum-based chemotherapy.
  • Patients must have a BRCA1 or BRCA2 mutation.
  • At least 4 weeks must pass between the completion of prior treatment and receipt of the study treatment.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for patients age 18 to 71.

For more information about this study and to inquire about eligibility, please contact Dr. Kenneth Yu at 646-888-4188.

Protocol

20-504

Phase

I

Investigator

Co-Investigators