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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
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
No Placebo-Only Group

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.
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.
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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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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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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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I had chemotherapy for a different cancer within the last year, with a high risk of it coming back.
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I have a serious heart or blood vessel condition.
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I have fluid buildup due to cancer in my abdomen or chest.
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I am not willing to consume alcohol.
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I have a blockage in my bile ducts.
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My cancer has spread to my brain or spinal cord.
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I have high blood pressure in the veins of my spleen.
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I have very high blood pressure.
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I have not had a heart attack in the last 6 months.
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I have high blood pressure in the veins of my liver.
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My cancer has spread to my heart or eye.
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I have a serious kidney condition.
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I have a history of lung scarring or damage.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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 study objectives
Objective response according to RECIST version 1.1
Objective response rate in metastatic lesions
Overall Survival
+1 more
Other study objectives
Area Under the Concentration-Time Curve for Melphalan
Clearance of Melphalan
Distribution-Phase Half-Life of Melphalan
+3 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
Ethanol
2005
Completed Phase 4
~3000
BCNU
1996
Completed Phase 3
~1620
Melphalan
2008
Completed Phase 3
~1500

Find a Location

Who is running the clinical trial?

Myriad Genetics, Inc.Industry Sponsor
17 Previous Clinical Trials
5,563 Total Patients Enrolled
General Oncology, Inc.Lead Sponsor
Arnold Glazier, M.D.Study DirectorGeneral Oncology, Inc.
Kenneth H Yu, M.D.Principal InvestigatorMemorial Sloan Kettering Cancer Center
Colin D Weekes, M.D., Ph.D.Principal InvestigatorMassachusetts General Hospital

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
~2 spots leftby Dec 2025
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