General Oncology, Inc.
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.
In the current clinical trial, subjects will receive a combination of melphalan, BCNU, vitamin B12b, and vitamin C in conjunction with autologous stem cell infusion. The drug combination is designed to address multiple mechanisms of melphalan resistance. Investigational Treatment Description: * Hematopoietic Stem Cell Collection 1. Granulocyte colony-stimulating factor, and if needed Plerixafor, will be used to mobilize bone marrow stem cells, which will be collected by apheresis. 2. At least 2 bags of CD34+ cells, each containing at least 2 × 10\^6 cells/kg, will be prepared and stored…
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…
Intravenous melphalan (to be given in conjunction with the other listed drugs).
Intravenous BCNU (to be given in conjunction with the other listed drugs).
Intravenous vitamin B12b (to be given in conjunction with the other listed drugs).
Intravenous vitamin C (to be given in conjunction with the other listed drugs).
After each cycle of chemotherapy, participants will receive an autologous hematopoietic stem cell infusion.