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A Study of Melphalan, BCNU, Vitamin B12b, Vitamin C, and Stem Cell Infusion in People with Advanced Pancreatic Cancer and BRCA Mutations

A Study of Melphalan, BCNU, Vitamin B12b, Vitamin C, and Stem Cell Infusion in People with Advanced Pancreatic Cancer and BRCA Mutations

Clinicaltrials.gov identifier:
NCT04150042

Treatment:
Pancreatic

Study Contact Information:

Principal Inviestigator, Dr. Kenneth Yu at 646-888-4188.


A Study of Melphalan, BCNU, Vitamin B12b, Vitamin C, and Stem Cell Infusion in People with Advanced Pancreatic Cancer and BRCA Mutations

About the Study

The purpose of this study is to see whether the combination of melphalan, BCNU, vitamin B12b, and vitamin C, followed by autologous (self) bone marrow stem cell infusion, is safe and effective for treating patients with advanced pancreatic cancer who have a BRCA1 and/or BRCA2 gene mutation. All of these treatments are given intravenously (by vein).

Melphalan and BCNU are both chemotherapy drugs that work by targeting the processes that cancer cells use to grow and spread. Vitamin B12b and vitamin C work together to block cancer cell energy production and prevent cancer cells from repairing the damage caused by the chemotherapy drugs. Autologous bone marrow stem cell infusion involves using healthy blood-forming cells from a patient's own body to replace diseased or damaged bone marrow. The stem cell infusions will help decrease the side effects of the study treatment.

What the Study Entails

  • All participants will receive the combination of melphalan, BCNU, vitamin B12b, and vitamin C, followed by autologous bone marrow stem cell infusion.
  • If you decide to take part in this study, you will undergo a procedure called apheresis to collect and preserve blood stem cells for the autologous bone marrow stem cell infusion. The stem cells collected from your blood are like seeds from which bone marrow will grow. 
  • About 1 week after the apheresis, you will be admitted to the hospital for your first study treatment. You will get melphalan, BCNU, vitamin B12b, and vitamin C, and then you will have an autologous bone marrow stem cell infusion 2 days later. You may be able to leave the hospital before you have your stem cell infusion, depending on how you respond to the study treatment.
  • You will stay in the hospital again about 6 weeks after your first study treatment to get a second treatment. You will also have a second stem cell infusion.
  • You will come to the clinic daily for 3 weeks following each stem cell infusion or until your blood test results have returned to normal.
  • After you finish your second study treatment, the study doctor will continue to follow your condition for 1 year and watch you for side effects. The study doctor or a member of the study team will call you monthly to check if you are having any side effects, and you will come to the clinic 1, 3, 6, 9, and 12 months after your second study treatment.
  • During the study, you will need to stay in the New York City area for about 3 months, and possibly longer. You must be in the area around the time that you are receiving study treatment and stem cell infusions so you can easily come to the clinic if you have side effects.

Site

New York City, NY: Memorial Sloan Kettering Cancer Center 
Dr. Kenneth Yu at 646-888-4188

This Study is Open To:

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have advanced pancreatic cancer.
  • Patients must have responded to  platinum-based chemotherapy.
  • Patients must have a BRCA1 or BRCA2 mutation.
  • At least 4 weeks must pass between the completion of prior treatment and receipt of the study treatment.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for patients age 18 to 71.
This Study is Not Open To:
  • Patients whose cancer has spread to the central nervous system, eye, or heart or who have malignant ascites.
  • Patients who have clinical or radiographical evidence of tumor resistance to PARP inhibitors.
  • Patients with a G6PD deficiency.