NCT04150042

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

SHARON: Study of Metastatic Cancers in Patients Using Autologous Stems Cells and Potentiated Redox Cycling to Overcome Drug Resistance to Nitrogen Mustard Derivatives

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: General Oncology, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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. 3. Mobilization of hematopoietic stem cells will only occur prior to the first cycle of investigational therapy. 4. If there is not a sufficient mobilization of stem cells for at least 2 cycles of chemotherapy, then no investigational drugs will be given. * Investigational Drug Therapy and Stem Cell Infusion 1. All subjects will receive two cycles of investigational drug therapy with stem cell infusion unless precluded by adverse reactions. 2. Subjects will receive on day -2: 1. BCNU 2. Melphalan 3. Vitamin B12b 4. Vitamin C 3. On day 0, at least 2 × 10\^6 CD34+ cells/kg will be infused as per the institution's standard procedures. 4. Subjects will receive supportive care as per the institution's standard procedures before, during, and after the investigational drug therapy and stem cell infusion. * Additional Cycles a. Subjects will receive a second cycle of the investigational treatment described immediately above in "Investigational Drug Therapy and Stem Cell Infusion," with an interval of approximately 6 weeks between cycles.

Conditions

• Pancreatic Adenocarcinoma Metastatic
• BRCA1 Mutation
• BRCA2 Mutation
• Pancreatic Acinar Cell Carcinoma
• Pancreatic Ductal Adenocarcinoma
• Pancreatic Cancer
• Metastatic Pancreatic Cancer
• Metastatic Pancreatic Ductal Adenocarcinoma
• Breast Cancer Metastatic
• Breast Cancer Stage IV
• Pancreatic Cancer Stage IV
• HER2-negative Breast Cancer
• HER2 Negative Breast Carcinoma
• Adenocarcinoma of the Breast
• PALB2 Gene Mutation
• Pancreas Cancer, Metastatic
• Pancreas Cancer, Recurrent
• Pancreas Cancer
• Stage IV Pancreatic Cancer
• Stage 4 Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	Melphalan	Intravenous melphalan (to be given in conjunction with the other listed drugs).
DRUG	BCNU	Intravenous BCNU (to be given in conjunction with the other listed drugs).
DRUG	Vitamin B12B	Intravenous vitamin B12b (to be given in conjunction with the other listed drugs).
DRUG	Vitamin C	Intravenous vitamin C (to be given in conjunction with the other listed drugs).
DEVICE	Autologous Hematopoietic Stem Cells	After each cycle of chemotherapy, participants will receive an autologous hematopoietic stem cell infusion.

Timeline

• Start date: 2021-01-13
• Primary completion: 2028-12-01
• Completion: 2028-12-01
• First posted: 2019-11-04
• Last updated: 2026-01-29

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study