OncoMatch/Clinical Trials/NCT04150042
SHARON: A Clinical Trial for Metastatic Cancer Using Chemotherapy and Patients' Own Stem Cells
Is NCT04150042 recruiting? Yes, currently enrolling (May 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
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 →
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