SHARON: A Clinical Trial for Metastatic Cancer Using Chemotherapy and Patients' Own Stem Cells
Trial Parameters
Brief Summary
The clinical trial is a phase 1, single-arm trial that will evaluate the safety of the investigational treatment on metastatic pancreatic cancer and metastatic breast cancer. The investigational treatment will involve 2 cycles of a combination of intravenous melphalan, BCNU, vitamin B12b, and vitamin C with autologous hematopoietic stem cell infusion. A dose-escalation schedule is being employed for the vitamin C.
Eligibility Criteria
Inclusion Criteria * Age ≥ 18 years. * Pancreatic or breast cancer, as described below. * Stage IV (based on AJCC staging guidelines) at the time of enrollment. a. Note that potential subjects with stage IV cancer that have had a complete response from prior chemotherapy are still potentially eligible. * Expected survival time ≥ 6 months, as determined by the investigator. * Life expectancy not severely limited by diseases other than malignancy, as determined by the investigator. * Karnofsky score ≥ 60%. * No chemotherapy within 2 weeks of enrollment. * Prior surgical resection or ablation of the primary tumor is allowed but not required. * If post-surgical, the subject must be at least 28 days post-op with the surgical wounds healed and significant complications resolved. * Potential subjects who have received previous chemotherapy and/or PARP inhibitors may be enrolled. * Measurable or non-measurable disease by the revised response evaluation criteria in solid tumors (RECIST) v.1.1.