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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 belowSelect...
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.
Select...
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:Select...
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 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
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 moreSecondary study objectives
Objective response according to RECIST version 1.1
Objective response rate in metastatic lesions
Overall Survival
+1 moreOther study objectives
Area Under the Concentration-Time Curve for Melphalan
Clearance of Melphalan
Distribution-Phase Half-Life of Melphalan
+3 moreAwards & 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.
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your disease can be measured or seen on medical tests using specific guidelines.My life expectancy is mainly affected by my cancer, not other diseases.I am able to care for myself but may not be able to do active work.I haven't had chemotherapy in the last 2 weeks.I had chemotherapy for a different cancer within the last year, with a high risk of it coming back.I have a serious heart or blood vessel condition.I have had surgery or ablation to remove my primary tumor.Abnormal test results from lab tests.I have fluid buildup due to cancer in my abdomen or chest.You are expected to live for at least 6 months.I am not willing to consume alcohol.I have a blockage in my bile ducts.I have cholangitis but meet specific treatment conditions.You have signs of sinusoidal obstruction syndrome.My breast cancer is of the type called adenocarcinoma.My cancer has spread to my brain or spinal cord.I have high blood pressure in the veins of my spleen.I have stage IV pancreatic or breast cancer, even if I responded well to previous chemotherapy.I have a BRCA1, BRCA2, or PALB2 gene mutation.I agree to use contraception.My pancreatic cancer is either ductal adenocarcinoma or acinar cell carcinoma.I have a BRCA1, BRCA2, or PALB2 gene mutation.You have a heart condition that makes your heart rhythm last longer than usual on an EKG test.I have very high blood pressure.I have not had a heart attack in the last 6 months.I have high blood pressure in the veins of my liver.My cancer has spread to my heart or eye.I am 18 years old or older.The presence of other medical conditions and reasons not to participate in the study.I have a serious kidney condition.I am either male or female.You have to have a biopsy or other tests to confirm the type of cancer you have.I have a history of lung scarring or damage.Your heart's pumping ability is less than 45%.
Research Study Groups:
This trial has the following groups:- Group 1: Chemotherapy/stem cell treatment
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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