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

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.

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

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.

Sponsors & Collaborators

• Myriad Genetics, Inc.

  collaborator INDUSTRY

• General Oncology, Inc.

  lead INDUSTRY

Principal Investigators

• Arnold Glazier, M.D. · General Oncology, Inc.

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-01-13

Primary Completion

2028-12-31

Completion

2028-12-31

FDA Drug

Yes

FDA Device

Yes

Countries

• United States

Study Locations