OncoMatch/Clinical Trials/NCT04150042
SHARON: A Clinical Trial for Metastatic Cancer Using Chemotherapy and Patients' Own Stem Cells
Is NCT04150042 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1 trial studies multiple treatments for pancreatic adenocarcinoma metastatic.
Treatment: Melphalan · BCNU · Vitamin B12B · Vitamin C · Autologous Hematopoietic Stem Cells — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Chemotherapy
Other
Cancer type
Pancreatic Cancer
Breast Carcinoma
Biomarker criteria
Required: HER2 (ERBB2) wild-type
HER2-negative cancer as per American Society of Clinical Oncology/College of American Pathologists human epidermal growth factor receptor 2 (HER2) testing in breast cancer guidelines.
Allowed: BRCA1 deleterious mutation
germline BRCA1...mutation must be known to be deleterious or suspected to cause functional impairment as assessed by a CLIA-certified laboratory... For somatic BRCA1...mutation must be a known or suspected deleterious mutation...biallelic loss or inactivation...Genetics Review Committee...must agree that the biallelic mutations are deleterious or suspected deleterious.
Allowed: BRCA2 deleterious mutation
germline BRCA2...mutation must be known to be deleterious or suspected to cause functional impairment as assessed by a CLIA-certified laboratory... For somatic BRCA2...mutation must be a known or suspected deleterious mutation...biallelic loss or inactivation...Genetics Review Committee...must agree that the biallelic mutations are deleterious or suspected deleterious.
Allowed: PALB2 deleterious mutation
germline PALB2...mutation must be known to be deleterious or suspected to cause functional impairment as assessed by a CLIA-certified laboratory... For somatic PALB2...mutation must be a known or suspected deleterious mutation...biallelic loss or inactivation...Genetics Review Committee...must agree that the biallelic mutations are deleterious or suspected deleterious.
Disease stage
Required: Stage IV
Metastatic disease required
Prior therapy
Must have received: platinum-based chemotherapy — first-line
at least 16 weeks of first-line (platinum-based*) chemotherapy with no evidence of treatment failure
Cannot have received: bone marrow stem cell transplant
Prior bone marrow stem cell transplant
Cannot have received: bleomycin (bleomycin)
Prior treatment with bleomycin
Cannot have received: BCNU (BCNU)
Prior treatment with BCNU
Lab requirements
Blood counts
No evidence of bone marrow insufficiency or failure; Hemoglobin ≥ 9 g/dL; No hemolytic anemia; No G6PD deficiency; No pre-existing bleeding diathesis or coagulopathy
Kidney function
Corrected creatinine clearance ≥ 50 ml/min/1.73 m^2; No clinically significant renal disease; Plasma oxalate ≤ 10 µM; No history of significant elevation of plasma oxalic acid or complications
Liver function
Total bilirubin ≤ 2x upper normal limit (except Gilbert's Disease permitted); 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
Cardiac function
Left ventricular ejection fraction ≥ 45% by MUGA or echo; No clinically significant structural heart disease or vascular disease; No MI within 6 months; No NYHA Class III/IV heart failure; No angina; No uncontrolled ventricular arrhythmias; No acute ischemia or active conduction system abnormalities; QTc (Bazett) ≤ 0.45 s (males), ≤ 0.47 s (females); No severe hypertension (systolic ≤ 165 mm Hg, diastolic ≤ 110 mm Hg); No other clinically significant cardiovascular disease
See exclusion criteria for full details: LVEF < 45%, significant heart disease, MI within 6 months, NYHA III/IV, angina, arrhythmias, QTc > 0.45s (males)/0.47s (females), severe hypertension, etc. Total bilirubin > 2x ULN (except Gilbert's), ALT/AST > 2.5x ULN, Alk Phos > 2.5x ULN with elevated GGT, albumin < 3.0 g/dl, CrCl < 50 ml/min/1.73m^2, etc.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Massachusetts General Hospital · Boston, Massachusetts
- Memorial Sloan Kettering Cancer Center · New York, New York
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT04150042 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior bone marrow stem cell transplant, bleomycin, BCNU disqualifies patients from enrollment.
Does this trial require ERBB2?
Yes, ERBB2 wild-type is a required biomarker for enrollment.
What disease stage is eligible?
Stage IV is required (metastatic disease required).
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages