Ignite Creation Date:
2024-05-06 @ 1:54 PM
Last Modification Date:
2024-10-26 @ 1:21 PM
Study NCT ID:
NCT04150042
Status:
RECRUITING
Last Update Posted:
2024-06-26
First Post:
2019-10-30
Brief Title:
SHARON A Clinical Trial for Metastatic Cancer With a BRCA or PALB2 Mutation Using Chemotherapy and Patients Own Stem Cells
Sponsor:
General Oncology Inc
Organization:
General Oncology Inc
Study Overview
Official Title:
SHARON Study of Metastatic Cancers in Patients With a Defect in a Homologous Recombination Gene Using Autologous Stems Cells and Potentiated Redox Cycling to Overcome Drug Resistance to Nitrogen Mustard Derivatives
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The clinical trial is a phase 1 single-arm trial that will evaluate the safety of the investigational treatment on metastatic cancer in patients who have a deleterious or suspected deleterious BRCA1 BRCA2 or PALB2 genetic alteration The investigational treatment will involve 2 cycles of a combination of intravenous melphalan BCNU low-dose IV ethanol vitamin B12b and vitamin C in association with autologous hematopoietic stem cell infusion A dose-escalation schedule will be employed for vitamin C
Detailed Description:
In the current clinical trial subjects with BRCA-related or PALB2-related metastatic pancreatic or breast 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 2 106 cellskg 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
1 BCNU
2 Melphalan
3 Vitamin B12b
4 Vitamin C
5 Ethanol
3 On day 0 at least 2 106 CD34 cellskg will be infused as per the institutions standard procedures
4 Subjects will receive supportive care as per the institutions 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
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 2 106 cellskg 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
1 BCNU
2 Melphalan
3 Vitamin B12b
4 Vitamin C
5 Ethanol
3 On day 0 at least 2 106 CD34 cellskg will be infused as per the institutions standard procedures
4 Subjects will receive supportive care as per the institutions 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None