Phase I 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
Summary
This phase I, single-arm trial will evaluate the safety of the investigational treatment on pancreatic cancer in patients who have an inherited, deleterious BRCA1 or BRCA2 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.
General Information
NCT#: NCT04150042
Study ID: GO-1
Trial Phase: Phase I
Trial Sponsor: General Oncology, Inc.
Therapies Used in This Trial: Ascorbic Acid, Ethanol, Melphalan, BCNU, hydroxocobalamin, Autologous bone marrow stem cell infusion