RecruitingPhase 1NCT04150042

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

Sponsor

General Oncology, Inc.

Enrollment

24 participants

Start Date

Jan 13, 2021

Study Type

INTERVENTIONAL

Conditions

Breast Cancer Metastatic Pancreatic Cancer HER2-negative Breast Cancer Metastatic Pancreatic Cancer Pancreatic Adenocarcinoma Metastatic BRCA1 Mutation BRCA2 Mutation Pancreatic Acinar Cell Carcinoma Pancreatic Ductal Adenocarcinoma Metastatic Pancreatic Ductal Adenocarcinoma Breast Cancer Stage IV Pancreatic Cancer Stage IV

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study (called SHARON) is testing a treatment for metastatic (stage IV) breast or pancreatic cancer that combines standard chemotherapy with a patient's own stem cells. Stem cells are harvested from the patient, stored, and given back after chemotherapy to help the body recover faster — potentially allowing higher doses of chemo. The goal is to see if this approach improves outcomes. **You may be eligible if...** - You are 18 or older with stage IV pancreatic or breast cancer - Your expected survival is at least 6 months - You are in reasonable health (Karnofsky score 60% or above) - You have not had chemotherapy in the last 2 weeks - You are at least 28 days past any recent surgery and have healed **You may NOT be eligible if...** - You have significant health problems unrelated to your cancer that limit your life expectancy - You received chemotherapy very recently Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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 Hospital

Boston, Massachusetts, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT04150042

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