NCT04150042 - SHARON: A Clinical Trial for Metastatic Cancer With a BRCA or PALB2 Mutation Using Chemotherapy and Patients' Own Stem Cells | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

January 13, 2021

Primary Completion Date

August 31, 2026

Study Completion Date

August 31, 2027

Conditions

Pancreatic Adenocarcinoma MetastaticBRCA1 MutationBRCA2 MutationPancreatic Acinar Cell CarcinomaPancreatic Ductal AdenocarcinomaPancreatic CancerMetastatic Pancreatic CancerMetastatic Pancreatic Ductal AdenocarcinomaBreast Cancer MetastaticBreast Cancer Stage IVPancreatic Cancer Stage IVHER2-negative Breast CancerHER2 Negative Breast CarcinomaAdenocarcinoma of the BreastPALB2 Gene Mutation

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).

DRUG

Ethanol

Intravenous ethanol (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.

Trial Locations (2)

10065

RECRUITING

Memorial Sloan Kettering Cancer Center, New York

02114

ACTIVE_NOT_RECRUITING

Massachusetts General Hospital, Boston