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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
Life expectancy not severely limited by diseases other than malignancy
Karnofsky score ≥ 60%
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 48 hours of vitamin c treatment
Awards & highlights

Study 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
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My life expectancy is mainly affected by my cancer, not other diseases.
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I am able to care for myself but may not be able to do active work.
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I haven't had chemotherapy in the last 2 weeks.
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I have had surgery or ablation to remove my primary tumor.
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My breast cancer is of the type called adenocarcinoma.
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I have stage IV pancreatic or breast cancer, even if I responded well to previous chemotherapy.
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I have a BRCA1, BRCA2, or PALB2 gene mutation.
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I agree to use contraception.
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My pancreatic cancer is either ductal adenocarcinoma or acinar cell carcinoma.
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I have a BRCA1, BRCA2, or PALB2 gene mutation.
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I am 18 years old or older.
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I am either male or female.

Timeline

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
Vitamin C
2017
Completed Phase 4
~18470
BCNU
1996
Completed Phase 3
~1620
Ethanol
2005
Completed Phase 4
~3000
Melphalan
2008
Completed Phase 3
~1500

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people are the researchers hoping to test in this clinical trial?

"Yes, this is an active trial. As the clinicaltrials.gov website indicates, the study was posted on 1/13/2021 and updated on 11/4/2022. They are currently looking for 10 participants at 2 sites."

Answered by AI

Who would be most likely to see benefits from participating in this trial?

"Eligibility requirements for this pancreatic cancer study include being between 18 and 70 years old as well as having a specific type of the disease (ductal adenocarcinoma). A maximum of 10 patients can take part in the clinical trial."

Answered by AI

What maladies has Autologous Hematopoietic Stem Cells shown to be helpful for?

"Autologous Hematopoietic Stem Cells are most commonly used to address vitamin deficiencies. However, this treatment can also be used for blood disorders like anemia, pernicious anemia, and multiple myeloma."

Answered by AI

Are young adults ineligible for this clinical research?

"The age limit for this particular study is 18 to 70. In contrast, there are 85 clinical trials only involving patients under 18 and 1598 studies focused on those over 65 years old."

Answered by AI

Are there any current openings for people who want to participate in this trial?

"The information available on clinicaltrials.gov verifies that this study is still recruiting patients. The trial was first announced on January 13th, 2021 and has been updated as recently as November 4th, 2022. They are looking for a total of 10 individuals who will be participating at 2 different locations."

Answered by AI

Does the FDA condone Autologous Hematopoietic Stem Cells as a treatment?

"Because this is an early Phase 1 trial, there is only limited data supporting the safety and efficacy of Autologous Hematopoietic Stem Cells."

Answered by AI

Are Autologous Hematopoietic Stem Cells a new or innovative treatment?

"City of Hope Comprehensive Cancer Center first studied Autologous Hematopoietic Stem Cells in 1997 and, since then, 622 completed studies exist with 235 clinical trials still active. Many of these ongoing medical studies are based out of New york City."

Answered by AI

What goals does this research hope to realize?

"The primary goal of this clinical trial is to assess the rate of delayed engraftment of platelets in patients. Secondary objectives include assessing the objective response rate in metastatic lesions and overall survival. These outcomes will be measured on Day 21 after each treatment, using CT scans with contrast of the abdomen, pelvis, and chest (among other sites as clinically indicated)."

Answered by AI

Who else is applying?

What state do they live in?
Kentucky
How old are they?
65+
What site did they apply to?
Memorial Sloan Kettering Cancer Center
Massachusetts General Hospital
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria

How responsive is this trial?

Most responsive sites:
  1. Massachusetts General Hospital: < 24 hours
Average response time
  • < 1 Day
Typically responds via
Email
~3 spots leftby Dec 2025