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

  • STATUS
    Recruiting
  • End date
    May 8, 2024
  • participants needed
    10
  • sponsor
    General Oncology, Inc.
Updated on 8 June 2022
cancer chemotherapy
BRCA1
BRCA2

Summary

The clinical trial is a phase 1, single-arm trial that will evaluate the safety of the investigational treatment on pancreatic cancer in patients who have an inherited, deleterious BRCA1 or BRCA2 genetic alteration. The investigational treatment will involve 2 cycles of a combination of intravenous melphalan, BCNU, low-dose I.V. ethanol, vitamin B12b, and vitamin C in association with autologous hematopoietic stem cell infusion. A dose-escalation schedule will be employed for vitamin C

Description

In the current clinical trial, participants with BRCA-related metastatic pancreatic cancer will receive a combination of melphalan, BCNU, low-dose ethanol, vitamin B12b, and vitamin C in conjunction with autologous stem cell infusion. The drug combination is designed to address multiple mechanisms of melphalan resistance. The purpose of the ethanol is the protection of RBC catalase activity.

Investigational Treatment Description:

  • Hematopoietic Stem Cell Collection
    1. Granulocyte colony-stimulating factor, and if needed Plerixafor, will be used to mobilize bone marrow stem cells, which will be collected by apheresis.
    2. At least 2 bags of CD34+ cells, each containing at least 2 × 10^6 cells/kg, will be prepared and stored.
    3. Mobilization of hematopoietic stem cells will only occur prior to the first cycle of investigational therapy.
    4. If there is not a sufficient mobilization of stem cells for at least 2 cycles of chemotherapy, then no investigational drugs will be given.
  • Investigational Drug Therapy and Stem Cell Infusion
    1. All subjects will receive two cycles of investigational drug therapy with stem cell infusion unless precluded by adverse reactions.
    2. Subjects will receive on day -2:
    3. BCNU
    4. Melphalan
    5. Vitamin B12b
    6. Vitamin C
    7. Ethanol
    8. On day 0, at least 2 × 10^6 CD34+ cells/kg will be infused as per the institution's standard procedures.
    9. Subjects will receive supportive care as per the institution's standard procedures before, during, and after the investigational drug therapy and stem cell infusion.
  • Additional Cycles a. Subjects will receive a second cycle of the investigational treatment described immediately above in "Investigational Drug Therapy and Stem Cell Infusion," with an interval of approximately 6 weeks between cycles.

Details
Condition Pancreatic Adenocarcinoma Metastatic, BRCA1 Mutation, BRCA2 Mutation, Pancreatic Acinar Cell Carcinoma, Pancreatic Ductal Adenocarcinoma, Pancreatic Cancer, Metastatic Pancreatic Cancer, Metastatic Pancreatic Ductal Adenocarcinoma
Treatment melphalan, Vitamin C, BCNU, Ethanol, Autologous Hematopoietic Stem Cells, Vitamin B12B, Vitamin B12B
Clinical Study IdentifierNCT04150042
SponsorGeneral Oncology, Inc.
Last Modified on8 June 2022

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