Actively Recruiting
SHARON: Study of Metastatic Cancers Using Autologous Stem Cells and Potentiated Redox Cycling to Overcome Drug Resistance
Led by General Oncology, Inc. · Updated on 2026-01-29
24
Participants Needed
2
Research Sites
N/A
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
Researchers are evaluating the safety of a new combination treatment for adults with metastatic pancreatic or breast cancer. This phase 1, single-arm trial focuses on using chemotherapy drugs along with patients' own stem cells to overcome resistance to treatment. The investigational therapy combines intravenous melphalan, BCNU, vitamin B12b, and vitamin C, with vitamin C doses being gradually increased. The study is sponsored by General Oncology, Inc., and aims to assess how well patients tolerate this approach. Participants will first have their own hematopoietic stem cells collected after receiving medications that help mobilize these cells from bone marrow. At least two collections of stem cells are required before starting treatment. The investigational drug therapy consists of two cycles, each involving intravenous administration of BCNU, melphalan, vitamin B12b, and vitamin C given on day -2, followed by an infusion of the stored stem cells on day 0. The two cycles are spaced about six weeks apart. Supportive care is provided throughout the treatment periods. During the study, participants will be closely monitored for side effects such as sinusoidal obstruction syndrome, pulmonary toxicity, kidney issues, mucositis, and blood cell recovery problems for up to 12 months after treatment. Researchers will also assess tumor response using imaging criteria at multiple time points after stem cell infusions. Participants will have regular evaluations including laboratory tests and clinical exams to track overall health, treatment effects, and safety outcomes. Total participation may extend for at least a year after the second stem cell treatment.
CONDITIONS
Brief 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
- Diagnosed with stage IV pancreatic or breast cancer
- Expected survival of at least 6 months
- Karnofsky performance score of 60% or higher
- No chemotherapy within 2 weeks before enrollment
- Prior surgery allowed if wounds are healed and complications resolved
- Previous chemotherapy or PARP inhibitors allowed
- Measurable or non-measurable disease by RECIST v1.1
- Known deleterious or suspected BRCA1, BRCA2, or PALB2 mutation or meeting specific chemotherapy treatment history
- For pancreatic cancer: ductal adenocarcinoma or acinar cell carcinoma
- For breast cancer: adenocarcinoma, HER2-negative, male or female
- Histological or cytological confirmation of primary cancer
- Metastatic disease confirmed or clinically judged
- Agreement to use effective contraception for females and males of childbearing potential during and 6 months after treatment
You will not qualify if you...
- Rapid disease progression or risk of rapid deterioration
- Biliary tract obstruction or current cholangitis
- Portal hypertension or significant major vein/artery obstruction
- Clinically significant malignant ascites or pleural effusion
- Metastases to heart or eye
- Recent chemotherapy for other indications with high recurrence risk
- Known or suspected CNS metastases
- Left ventricular ejection fraction below 45%
- Significant cardiovascular disease or severe hypertension
- History or evidence of interstitial lung disease
- Smoking refusal during trial
- Poor lung function (FEV1 or DLCO < 50%)
- Elevated liver enzymes or bilirubin (except Gilbert's disease)
- Low albumin or renal function
- Hemolytic anemia or G6PD deficiency
- Pre-existing bleeding disorders
- Pregnancy or breastfeeding without willingness to stop
- Wilson's disease or hemochromatosis
- High Hgb A1c or uncontrolled hyperuricemia
- Prior hepatitis B or C, HIV infection
- Active serious infections or colonization with resistant bacteria
- Uncontrolled seizures
- Prior radiation to brain, kidneys, pelvis, or GI tract (except adjuvant breast/pancreatic therapy)
- Prior treatment with bleomycin or BCNU
- Recent use of non-FDA-approved drugs
- Unresolved toxicities from prior chemotherapy
- Concurrent anticancer treatments
- Serious medical or psychiatric illness affecting participation
- Inability or unwillingness to follow protocol
- Unwillingness to receive ethanol during treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Prior to first treatment cycle
Participants receive granulocyte colony-stimulating factor and, if needed, Plerixafor to mobilize bone marrow stem cells which are collected by apheresis and stored for treatment.
1 to 2 visits for stem cell mobilization and collection
Duration - Two cycles with approximately 6 weeks between cycles
Participants receive two cycles of investigational drug therapy with melphalan, BCNU, vitamin B12b, and vitamin C followed by infusion of their own stored hematopoietic stem cells. Supportive care is provided according to standard procedures.
2 treatment cycles each involving medication administration on day -2 and stem cell infusion on day 0
Duration - Up to 12 months after treatment completion
Participants are monitored for safety and treatment outcomes including adverse events and disease response for up to 12 months after the second stem cell treatment.
Regular follow-up visits as scheduled by the study team
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)
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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