SHARON: Study of Metastatic Cancers in Patients Using Autologous Stems Cells and Potentiated Redox Cycling to Overcome Drug Resistance to Nitrogen Mustard Derivatives
General Oncology, Inc.
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.
Description
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…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DrugMelphalan
Intravenous melphalan (to be given in conjunction with the other listed drugs).
- DrugBCNU
Intravenous BCNU (to be given in conjunction with the other listed drugs).
- DrugVitamin B12B
Intravenous vitamin B12b (to be given in conjunction with the other listed drugs).
- DrugVitamin C
Intravenous vitamin C (to be given in conjunction with the other listed drugs).
- DeviceAutologous Hematopoietic Stem Cells
After each cycle of chemotherapy, participants will receive an autologous hematopoietic stem cell infusion.
Locations (2)
- Massachusetts General HospitalBoston, Massachusetts
- Memorial Sloan Kettering Cancer CenterNew York, New York