Actively Recruiting
SHARON: A Clinical Trial for Metastatic Cancer Using Chemotherapy and Patients' Own Stem Cells
Led by General Oncology, Inc. · Updated on 2026-01-29
24
Participants Needed
2
Research Sites
411 weeks
Total Duration
On this page
Sponsors
G
General Oncology, Inc.
Lead Sponsor
M
Myriad Genetics, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
SHARON: A Clinical Trial for Metastatic Cancer Using Chemotherapy and Patients' Own Stem Cells
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Diagnosis of pancreatic or breast cancer with stage IV disease at enrollment
- Expected survival time of at least 6 months
- Karnofsky performance score of 60% or higher
- No chemotherapy within 2 weeks prior to enrollment
- Prior surgery or ablation allowed if wounds healed and complications resolved
- Previous chemotherapy or PARP inhibitors allowed
- Measurable or non-measurable disease by RECIST v1.1 criteria
- For germline BRCA1, BRCA2, or PALB2 mutations, mutations must be deleterious or suspected as assessed by a certified laboratory
- For somatic BRCA1, BRCA2, or PALB2 mutations, must have deleterious mutations with biallelic loss confirmed and approved by Genetics Review Committee
- Patients without BRCA1/2/PALB2 mutations must have received at least 16 weeks of first-line platinum-based chemotherapy without treatment failure
- Pancreatic cancer patients must have ductal adenocarcinoma or acinar cell carcinoma
- Breast cancer patients must have adenocarcinoma of the breast and HER2-negative status
- Histological or cytological confirmation of primary cancer
- Metastatic disease confirmation unless biopsy deemed unnecessary
- Female participants of childbearing potential must agree to effective contraception or abstinence through 6 months post-treatment
- Male participants must agree to effective contraception or abstinence through 6 months post-treatment
You will not qualify if you...
- Rapid disease progression or risk of rapid symptomatic deterioration
- Biliary tract obstruction or current cholangitis
- Multiple episodes of cholangitis with high risk for recurrence
- Portal hypertension or significant major vein or artery obstruction
- Clinically significant malignant ascites, pleural effusion, or metastatic lesions to heart or eye
- Chemotherapy for other cancers within past year with high recurrence risk
- Known or suspected CNS metastases
- Left ventricular ejection fraction below 45%
- Significant cardiovascular disease or recent myocardial infarction
- Prolonged QTc on EKG beyond specified limits
- Severe hypertension or significant uncontrolled cardiovascular conditions
- History or evidence of interstitial lung disease
- Smoking refusal to quit during trial
- Lung function (FEV1 or DLCO) below 50% predicted
- Elevated liver enzymes or bilirubin exceeding limits (exceptions for Gilbert's Disease)
- Albumin below 3.0 g/dl
- Sinusoidal obstruction syndrome
- Renal impairment with creatinine clearance below 50 ml/min/1.73 m2
- Hemolytic anemia or bone marrow insufficiency
- Catalase deficiency or severe reaction to hydrogen peroxide without exclusion testing
- Hemoglobin below 9 g/dL
- G6PD deficiency
- Bleeding disorders
- Pregnancy or breastfeeding unwilling to stop
- Wilson's disease or hemochromatosis
- Poorly controlled diabetes with Hgb A1c above 9%
- Hyperuricemia or plasma oxalate levels not responsive to treatment
- History of hepatitis B or C, HIV infection
- Active significant infections or colonization with multidrug-resistant organisms
- Uncontrolled seizure disorder
- Prior radiation to specific organs exceeding dose limits
- Allergies to study drugs or excipients
- Recent use of certain CYP2b6 inducers or disulfiram
- Chronic immunosuppressive therapy
- Prior bone marrow transplant
- Prior treatment with bleomycin or BCNU
- Recent use of unapproved drugs
- Unresolved toxicities from prior chemotherapy above grade 1 except alopecia and grade 2 neuropathy
- Concurrent anticancer treatments
- Serious medical, psychiatric, or other conditions interfering with study participation
- Inability or unwillingness to follow study protocol
- Unwillingness to receive ethanol during study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Completed
2
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
Research Team
G
General Oncology (study sponsor)
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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