SHARON Phase 1 Trial of Chemotherapy with Autologous Stem Cell Infusion for Metastatic Pancreatic and Breast Cancer

What this Trial Is About

Researchers are evaluating the safety of a new combination treatment for adults with metastatic pancreatic or breast cancer. This phase 1, single-arm trial focuses on using chemotherapy drugs along with patients own stem cells to overcome resistance to treatment. The investigational therapy combines intravenous melphalan, BCNU, vitamin B12b, and vitamin C, with vitamin C doses being gradually increased. The study is sponsored by General Oncology, Inc., and aims to assess how well patients tolerate this approach. Participants will first have their own hematopoietic stem cells collected after receiving medications that help mobilize these cells from bone marrow. At least two collections of stem cells are required before starting treatment. The investigational drug therapy consists of two cycles, each involving intravenous administration of BCNU, melphalan, vitamin B12b, and vitamin C given on day -2, followed by an infusion of the stored stem cells on day 0. The two cycles are spaced about six weeks apart. Supportive care is provided throughout the treatment periods. During the study, participants will be closely monitored for side effects such as sinusoidal obstruction syndrome, pulmonary toxicity, kidney issues, mucositis, and blood cell recovery problems for up to 12 months after treatment. Researchers will also assess tumor response using imaging criteria at multiple time points after stem cell infusions. Participants will have regular evaluations including laboratory tests and clinical exams to track overall health, treatment effects, and safety outcomes. Total participation may extend for at least a year after the second stem cell treatment.

SHARON: A Clinical Trial for Metastatic Cancer Using Chemotherapy and Patients' Own Stem Cells