Health Trials

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

ConditionsPancreatic 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 MutationPancreas Cancer, MetastaticPancreas Cancer, RecurrentPancreas CancerStage IV Pancreatic CancerStage 4 Pancreatic Cancer
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorGeneral Oncology, Inc.

About this trial

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 criteria

Qualifiers

Age ≥ 18 years.

Pancreatic or breast cancer, as described below.

Stage IV (based on AJCC staging guidelines) at the time of enrollment.

Expected survival time ≥ 6 months, as determined by the investigator.

Disqualifiers

Rapid disease progression or clinical features concerning for onset of rapid symptomatic deterioration, as determined by the investigator.

Biliary tract obstruction.

Current cholangitis. A biliary stent in situ does not otherwise exclude protocol participation.

A history of only one episode of cholangitis and fewer than 30 days have passed since discontinuation of antibiotic treatment.

Trial design

Treatments tested in this trial

  • Melphalan
  • BCNU
  • Vitamin B12B
  • Vitamin C
  • Autologous Hematopoietic Stem Cells

Treatment groups

24 Participants
are divided into 1 treatment group

Sponsors and collaborators

General Oncology, Inc.

Lead sponsor

Myriad Genetics, Inc.

Collaborator

Source ClinicalTrials.gov