Back to search results

SHARON: A Clinical Trial for Metastatic Cancer Using Chemotherapy and Patients' Own Stem Cells

This study is testing a new treatment for metastatic pancreatic or breast cancer, especially if you have BRCA1 or BRCA2 gene changes. The treatment involves two cycles of chemotherapy using a combination of drugs: melphalan, BCNU, vitamin B12b, and vitamin C. After each chemotherapy cycle, you will receive an infusion of your own stem cells (autologous hematopoietic stem cells). Researchers want to see how safe this treatment is and if it causes side effects like liver or lung problems. The study is looking for about 24 participants and is currently evaluating safety.

Study design
This is a Phase 1, single-arm study, meaning all 24 participants will receive the same investigational treatment. The study is designed to evaluate the safety of the treatment.
What's involved
You will undergo a stem cell collection procedure before starting treatment. You will then receive two cycles of investigational drug therapy with stem cell infusions, unless side effects prevent it.
Compensation
Not stated in the trial record.
Follow-up
Researchers will check for liver problems 30 days after treatment. They will also check for lung problems at 3 months and 6 months after your last treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04150042

SHARON: A Clinical Trial for Metastatic Cancer Using Chemotherapy and Patients' Own Stem Cells

Recruiting
PHASE1Ages 18+InterventionalTreatment
General Oncology, Inc.
~24 participants
Updated 2026-01-29 on ClinicalTrials.gov
What's tested:MelphalanBCNUVitamin B12BVitamin CAutologous Hematopoietic Stem Cells

At a glance

Recruiting sites
1 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Rate of Sinusoidal obstruction syndrome
Measured over 30 days after treatment
+13 more outcomes measured

Conditions

Pancreatic Adenocarcinoma Metastatic
BRCA1 Mutation
BRCA2 Mutation
Pancreatic Acinar Cell Carcinoma
Pancreatic Ductal Adenocarcinoma
Pancreatic Cancer
Metastatic Pancreatic Cancer
Metastatic Pancreatic Ductal Adenocarcinoma
Breast Cancer Metastatic
Breast Cancer Stage IV
Pancreatic Cancer Stage IV
HER2-negative Breast Cancer
HER2 Negative Breast Carcinoma
Adenocarcinoma of the Breast
PALB2 Gene Mutation
Pancreas Cancer, Metastatic
Pancreas Cancer, Recurrent
Pancreas Cancer
Stage IV Pancreatic Cancer
Stage 4 Pancreatic Cancer

Explore related trials

Breast CarcinomaPancreatic CarcinomaBRCA1 GeneBRCA2 GenePartner and Localizer of BRCA2

Where it's being run

2 sites across 2 states
Massachusetts1
New York1

Study leadership

  • Arnold Glazier, M.D. · STUDY_DIRECTOR · General Oncology, Inc.

Who to contact

General Oncology (study sponsor)
[email protected]
818-4-SHARON (818-474-2766)
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

Age ≥ 18 years.
Pancreatic or breast cancer, as described below.
Stage IV (based on AJCC staging guidelines) at the time of enrollment.
Expected survival time ≥ 6 months, as determined by the investigator.
Life expectancy not severely limited by diseases other than malignancy, as determined by the investigator.
Karnofsky score ≥ 60%.
No chemotherapy within 2 weeks of enrollment.
Prior surgical resection or ablation of the primary tumor is allowed but not required.
If post-surgical, the subject must be at least 28 days post-op with the surgical wounds healed and significant complications resolved.
Potential subjects who have received previous chemotherapy and/or PARP inhibitors may be enrolled.
Measurable or non-measurable disease by the revised response evaluation criteria in solid tumors (RECIST) v.1.1.
For potential subjects with a germline BRCA1, BRCA2, or PALB2 mutation:
For potential subjects with somatic BRCA1, BRCA2, or PALB2 mutations:
For subjects without a BRCA1, BRCA2, or PALB2 mutation
For potential subjects with pancreatic cancer:
For potential subjects with breast cancer:
Histological or cytological confirmation of the primary cancer diagnosis is required.
Metastatic disease must be histologically or cytologically confirmed unless in the clinical judgment of the investigator a biopsy is not needed for diagnostic purposes.
Female participants of childbearing potential must agree to do one of the following from the time of signing of the informed consent through 6 months after the last dose of melphalan:
Male participants:

Exclusion

Rapid disease progression or clinical features concerning for onset of rapid symptomatic deterioration, as determined by the investigator.
Biliary tract obstruction.
Current cholangitis. A biliary stent in situ does not otherwise exclude protocol participation.
A history of only one episode of cholangitis and fewer than 30 days have passed since discontinuation of antibiotic treatment.
A history of multiple episodes of cholangitis and after discussion between the site study team and sponsor medical monitor and careful evaluation for suitability the patient is deemed to be unsuitable for the trial due to risk of recurring cholangitis.
Portal hypertension.
Sinistral portal hypertension.
Obliteration or significant obstruction of the major veins or arteries (e.g., portal vein, superior mesenteric artery, superior mesenteric vein).
Clinically significant malignant ascites or malignant pleural effusion, as determined by the investigator.
Metastatic lesion to the heart or eye.
Chemotherapy for an indication other than treatment of the current cancer within the past 1 year with a more than 30% risk of recurrence as determined by the investigator.
Known or suspected metastatic involvement of the central nervous system.
Left ventricular ejection fraction less than 45% by Multigated Acquisition Scan or echocardiogram (or significantly below the lower limit of normal for the specific test).
Clinically significant structural heart disease or vascular disease.
Myocardial infarction within 6 months prior to enrollment; New York Heart Association (NYHA) Class III or IV heart failure; angina; uncontrolled ventricular arrhythmias; or electrocardiographic evidence of acute ischemia or active conduction system abnormalities.
Clinically significant prolongation of QTc (Bazett formula) on EKG, defined as \> 0.45 s in males and \> 0.47 s in females.
Severe hypertension, which is defined as the presence of any of the following:
Other clinically significant cardiovascular disease.
NOTE:
History or evidence of interstitial lung disease (e.g., pneumonitis or pulmonary fibrosis).
If a smoker, refusal to stop smoking for the duration of the trial.
FEV1 or DLCO (adjusted for hemoglobin) \< 50% of predicted.
Total bilirubin \> 2x upper normal limit, except that potential subjects with Gilbert's Disease are permitted to exceed 2x upper normal limit.
ALT or AST \> 2.5x upper normal limit.
Alkaline phosphatase \> 2.5x upper normal limit, in conjunction with elevated GGT.
Albumin \< 3.0 g/dl.
Clinical evidence of sinusoidal obstruction syndrome.
Corrected creatinine clearance consistently \< 50 ml/min/1.73 m\^2.
Clinically significant renal disease.
Hemolytic anemia.
Family history of catalase deficiency or history or evidence of a severe adverse reaction to hydrogen peroxide consistent with catalase deficiency, unless testing has demonstrated that the patient is not catalase-deficient.
Evidence of bone marrow insufficiency or failure, in the judgment of the investigator.
A hemoglobin \< 9 g/dL.
G6PD deficiency as measured by quantitative enzyme levels below the normal reference range in blood.
Pre-existing bleeding diathesis or coagulopathy.
Potential subject is pregnant.
Breast feeding and unwilling to stop.
Wilson's disease.
Primary or secondary hemochromatosis.
Hgb A1c \> 9%.
Hyperuricemia that is not responsive to therapy.
Plasma oxalate greater than 10 µM, which is not responsive to measures to reduce the level below 10 µM.
History of clinically significant elevation of plasma oxalic acid or complications related to oxalic acid.
Prior or current hepatitis B or C.
HIV infection or seropositivity for HIV.
Active, clinically significant bacterial, viral, or fungal infection.
History of colonization with a multidrug-resistant "superbug" that poses a high risk of an untreatable infection in the setting of neutropenia.
Uncontrolled seizure disorder.
If a potential subject has received radiation, then any of the following:
History of significant allergy or other contraindication to BCNU, melphalan, vitamin B12b, vitamin C, pegfilgrastim, or Neupogen, or to any excipient in those drugs.
Use of any of the following cytochrome P450 2b6 (CYP2b6) inducers within 21 days of the planned date of BCNU treatment: phenobarbital, carbamazepam, rifampicin, phenytoin, sulfinpyrazone, or verapamil.
Disulfiram (Antabuse) use within 30 days of the planned ethanol administration.
Current chronic use of immunosuppressive agents (e.g., methotrexate, cyclosporine, corticosteroids).
Prior bone marrow stem cell transplant.
Except for adjuvant therapy for breast cancer or pancreatic cancer, prior radiation therapy to the brain, kidneys, pelvis, or GI tract or treatment with yttrium-90.
Prior treatment with bleomycin or BCNU.
Prior treatment, within 30 days of enrollment, with a drug that has not been FDA-approved for any indication (cancer or otherwise).
Subject has not fully recovered (i.e., there remain toxicities \> Grade 1) from the reversible effects of prior chemotherapy, with the exception of chemotherapy-induced alopecia and grade 2 peripheral neuropathy, unless in the opinion of the principal investigator the effects are not of clinical significance.
Any concurrent anticancer treatment.
Serious underlying medical or psychiatric illness or another condition that in the clinical judgment of the principal investigator is likely to interfere with the potential subject completing participation in the trial, based on safety concerns or otherwise.
Inability or unwillingness to adhere to the study protocol.
Unwillingness to receive ethanol.

What this trial measures

  • Rate of Sinusoidal obstruction syndrome30 days after treatment

    Sinusoidal obstruction syndrome diagnosis and grading will use the European Society for Blood and Marrow Transplantation's Revised Diagnosis and Severity Criteria for Sinusoidal Obstruction Syndrome/Veno-Occlusive Disease in Adult Patients as published in 2016. Gradings are from mild to very severe (multi-organ dysfunction/multi-organ failure).

  • Rate of Idiopathic or Non-Infective Pulmonary Toxicity ≥ Grade 33 months after the last treatment

    The American Thoracic Society Committee on Idiopathic Pneumonia Syndrome definition will be employed.

  • Rate of Idiopathic or Non-Infective Pulmonary Toxicity ≥ Grade 36 months after the last treatment

    The American Thoracic Society Committee on Idiopathic Pneumonia Syndrome definition will be employed.

  • Rate of Presumptive Oxalate NephropathyWithin 48 hours of vitamin C treatment

    Oxalate nephropathy will be presumed if there is acute kidney injury or increased creatinine, grade 3 or higher by the criteria of CTCAE Version 5.0 within 48 h of the administration of vitamin C, in the absence of a clear alternative explanation (an example of an alternative explanation is tumor lysis syndrome).

  • Rate of Cytokine Release Syndrome ≥ Grade 3Within 48 hours of each vitamin C treatment

    Cytokine release syndrome will be assessed by the criteria of CTCAE Version 5.0. Elevation of plasma cytokine levels consistent with the diagnosis of cytokine release syndrome must be present.

  • Rate of Mucositis ≥ Grade 3Day 7 after each treatment

    Mucositis will be assessed using the WHO Mucositis Scale. Grading is from 0 (no symptoms) to 4 (no possible alimentation).

  • Rate of Mucositis ≥ Grade 3Day 14 after each treatment

    Mucositis will be assessed using the WHO Mucositis Scale. Grading is from 0 (no symptoms) to 4 (no possible alimentation).

  • Rate of Mucositis ≥ Grade 3Day 21 after each treatment

    Mucositis will be assessed using the WHO Mucositis Scale. Grading is from 0 (no symptoms) to 4 (no possible alimentation).

  • Rate of Delayed Engraftment of NeutrophilsDay 21 after each treatment

    Neutrophil engraftment is defined as an absolute neutrophil count ≥ 500/microliter for 3 days, with the date of engraftment being the first of those 3 days. Delayed engraftment is engraftment that occurs after 21 days but within 30 days.

  • Rate of Failed Engraftment of NeutrophilsDay 30 after each treatment

    Neutrophil engraftment is defined as an absolute neutrophil count ≥ 500/microliter for 3 days, with the date of engraftment being the first of those 3 days. Failure to engraft within 30 days will be considered an engraftment failure.

  • Rate of Delayed Engraftment of PlateletsDay 30 after each treatment

    Platelet engraftment is defined as a platelet count ≥ 20,000/microliter for 3 days, with the date of engraftment being the first of those 3 days. Delayed engraftment is engraftment that occurs after 30 days.

  • Overall incidence rate of adverse eventsUntil 12 months after the second stem cell treatment

    Adverse event is defined any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related.

  • Overall incidence rate of serious adverse eventsUntil 12 months after the second stem cell treatment

    An adverse event is considered serious if, in the view of either the investigator or Sponsor, it results in any of the following outcomes: * Death. * A life-threatening adverse event. * Inpatient hospitalization or prolongation of existing hospitalization. * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions. * A congenital anomaly or birth defect. Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious when, based upon appropriate medical judgment, they may jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the outcomes listed in this definition.

  • Overall incidence rate of Grade 3-5 adverse eventsUntil 12 months after the second stem cell treatment

    Grading will be measured using Common Terminology Criteria for Adverse Events version 5.0