Chemotherapy Plus Stem Cells for Advanced Pancreatic or Breast Cancer

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

Recruiting Phase 1 Interventional Study
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
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
24 (estimated)
Sponsor
General Oncology, Inc. · Industry
Who this trial is looking for

This trial is looking for adults with advanced pancreatic or breast cancer. Participants will receive a combination of chemotherapy and their own stem cells to help treat their cancer.

Are You a Good Fit for This Trial?

You may be able to join if

  • I am at least 18 years old.
  • I have stage IV pancreatic or breast cancer.
  • I have measurable disease.
  • My expected survival time is at least 6 months.
  • I can safely stop chemotherapy if currently being treated.
  • I have a Karnofsky score of at least 60%.
  • I have had surgery but no signs of cancer progression since.
  • I have a BRCA1, BRCA2, or PALB2 mutation, or I have received previous chemotherapy.

You may not be able to join if

  • I have rapidly progressing cancer.
  • I have current bile duct obstruction or cholangitis.
  • I have portal hypertension.
  • I have significant problems with major veins or arteries.
  • I have serious fluid buildup in my abdomen or chest due to cancer.
  • I have cancer that has spread to my heart or eyes.
  • I had chemotherapy for another cancer in the last year.
  • I have had multiple episodes of cholangitis.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

Think this trial could be right for you?

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About This Trial
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 f…
Trial Locations
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Eligibility Criteria
Inclusion Criteria * 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 el…
Contacts

General Oncology (study sponsor)

818-4-SHARON (818-474-2766)

contact@SharonTrial.com

CONTACT