← Back to Search

Stem Cell Transplantation

Chemotherapy + Stem Cell Transplant for Pancreatic Cancer

Phase 1

Recruiting

Led By Kenneth H Yu, M.D.

Research Sponsored by General Oncology, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Karnofsky score ≥ 60%

No chemotherapy within 2 weeks of enrollment

Must not have

Chemotherapy for an indication other than treatment of the current cancer within the past 1 year with a more than 30% risk of recurrence

Clinically significant structural heart disease or vascular disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up within 48 hours of vitamin c treatment

Awards & highlights

Summary

This trial is testing a new treatment for pancreatic cancer in patients with an inherited BRCA1 or BRCA2 mutation. The treatment involves a combination of drugs given through an IV, with the goal of determining if it is safe.

Who is the study for?

This trial is for adults with stage IV breast or pancreatic cancer who have a BRCA1, BRCA2, or PALB2 mutation. They should not have had chemotherapy in the last 2 weeks and must be expected to live at least another 6 months. Participants need a Karnofsky score of at least 60%, indicating they can care for themselves. Smokers must quit for the trial duration, and all participants agree to use contraception.Check my eligibility

What is being tested?

The SHARON trial tests a treatment combining chemotherapy drugs (melphalan, BCNU), vitamins (B12b, C), ethanol, and patients' own stem cells on metastatic cancer with specific genetic mutations. It's in phase 1 where safety is checked using increasing doses of vitamin C alongside other treatments given intravenously over two cycles.See study design

What are the potential side effects?

Potential side effects may include reactions from the chemotherapy like nausea, fatigue, hair loss; infusion-related issues due to stem cell transplant; possible organ damage from high-dose vitamin C; and complications related to ethanol administration.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am able to care for myself but may not be able to do active work.

Select...

I haven't had chemotherapy in the last 2 weeks.

Select...

My breast cancer is of the type called adenocarcinoma.

Select...

I have stage IV pancreatic or breast cancer, even if I responded well to previous chemotherapy.

Select...

I have a BRCA1, BRCA2, or PALB2 gene mutation.

Select...

My pancreatic cancer is either ductal adenocarcinoma or acinar cell carcinoma.

Select...

I have a BRCA1, BRCA2, or PALB2 gene mutation.

Select...

I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I had chemotherapy for a different cancer within the last year, with a high risk of it coming back.

Select...

I have a serious heart or blood vessel condition.

Select...

I have fluid buildup due to cancer in my abdomen or chest.

Select...

I am not willing to consume alcohol.

Select...

I have a blockage in my bile ducts.

Select...

My cancer has spread to my brain or spinal cord.

Select...

I have high blood pressure in the veins of my spleen.

Select...

I have very high blood pressure.

Select...

I have not had a heart attack in the last 6 months.

Select...

I have high blood pressure in the veins of my liver.

Select...

My cancer has spread to my heart or eye.

Select...

I have a serious kidney condition.

Select...

I have a history of lung scarring or damage.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ within 48 hours of vitamin c treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~within 48 hours of vitamin c treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and within 48 hours of vitamin c treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Overall incidence rate of Grade 3-5 adverse events

Overall incidence rate of adverse events

Overall incidence rate of serious adverse events

+7 more

Secondary outcome measures

Objective response according to RECIST version 1.1

Objective response rate in metastatic lesions

Overall Survival

+1 more

Other outcome measures

Area Under the Concentration-Time Curve for Melphalan

Clearance of Melphalan

Distribution-Phase Half-Life of Melphalan

+3 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Chemotherapy/stem cell treatmentExperimental Treatment6 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ethanol

2005

Completed Phase 4

~3000

BCNU

1996

Completed Phase 3

~1620

Vitamin C

2017

Completed Phase 4

~18470

Melphalan

2008

Completed Phase 3

~1500

0 / 21Eligibility criteria met

Find a Location

Who is running the clinical trial?

Myriad Genetics, Inc.Industry Sponsor

16 Previous Clinical Trials

5,379 Total Patients Enrolled

General Oncology, Inc.Lead Sponsor

Arnold Glazier, M.D.Study DirectorGeneral Oncology, Inc.

Media Library

Autologous Hematopoietic Stem Cells (Stem Cell Transplantation) Clinical Trial Eligibility Overview. Trial Name: NCT04150042 — Phase 1

Pancreatic Cancer Research Study Groups: Chemotherapy/stem cell treatment

Pancreatic Cancer Clinical Trial 2023: Autologous Hematopoietic Stem Cells Highlights & Side Effects. Trial Name: NCT04150042 — Phase 1

Autologous Hematopoietic Stem Cells (Stem Cell Transplantation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04150042 — Phase 1

~3 spots leftby Dec 2025

Unbiased ResultsWe believe in providing patients with all the options.

Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.

Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.