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

Recruiting now · Phase 1

Conditions studied: 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

In brief

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.

Key facts

Study ID

NCT04150042

Run by

General Oncology, Inc.

People needed

24

Starts

2021-01-13

Expected to finish

2028-12-01

Last updated by the study team

2026-01-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥ 18 years.
• Pancreatic or breast cancer, as described below.
• Stage IV (based on AJCC staging guidelines) at the time of enrollment.
• a. Note that potential subjects with stage IV cancer that have had a complete response from prior chemotherapy are still potentially eligible.
• 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:
• a. The mutation must be known to be deleterious or suspected to cause functional impairment as assessed by a CLIA-certified laboratory according to the variant classification criteria described in the study protocol.
• For potential subjects with somatic BRCA1, BRCA2, or PALB2 mutations:
• The mutation must be a known or suspected deleterious mutation as assessed by a CLIA-certified laboratory according to the variant classification criteria described in the study protocol.
• There must be biallelic loss or inactivation of the mutated BRCA1, BRCA2, or PALB2 gene as assessed by a CLIA-certified laboratory.
• The Genetics Review Committee for this trial, which is comprised of a core group of investigators and whose actions are performed in accordance with the committee's charter, must agree that the biallelic mutations are deleterious or suspected deleterious.
• For subjects without a BRCA1, BRCA2, or PALB2 mutation
• Subject must have received at least 16 weeks of first-line (platinum-based*) chemotherapy with no evidence of treatment failure, where treatment failure is defined as growing tumors, new lesions, or a steadily rising tumor marker during or within eight weeks of completion of the first line therapy.
• * Subjects can also have been treated with FOLFIRINOX but switched to FOLFIRI due to oxaliplatin side effects.
• For potential subjects with pancreatic cancer:
• Pancreatic ductal adenocarcinoma or pancreatic acinar cell carcinoma.
• If the potential subject has had surgical resection of the primary tumor, then there must be no evidence of disease progression between the time of surgical resection of the primary tumor and screening for enrollment if the patient is seeking enrollment in the immediate post-surgery period.
• For potential subjects with breast cancer:

You may not qualify if…

• 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:
• History of hypertensive crisis, hypertensive emergency, or malignant hypertension within the last year.
• Sustained or persistent systolic BP > 165 mm Hg or diastolic > 110 mm Hg.
• Other clinically significant cardiovascular disease.
• NOTE:
• A past history of severe hypertension that is well-controlled with therapy or that was addressed by removal of the cause (e.g., removal of a medicine that caused the severe hypertension) is not an exclusion criterion.
• The presence of a pacemaker is not a contraindication and is not considered an exclusion criterion
• 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.

Where it is running

• Memorial Sloan Kettering Cancer Center — New York, New York, United States (enrolling)
• Massachusetts General Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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