Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001880
Status:
TERMINATED
Last Update Posted:
2021-11-10
First Post:
2006-07-03
Brief Title:
Stem Cell Transplantation for Metastatic Solid Tumors
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Exploratory Study of Non-Myeloablative Allogeneic Stem Cell Transplantation and Donor Lymphocyte Infusions for Metastatic Neoplasms Refractory to Standard Therapy
Status:
TERMINATED
Status Verified Date:
2020-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study was closed early due to lack of accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this research study is to identify other types of cancer malignant neoplasms that may be treatable with stem cell transplantation allogenic peripheral blood stem cell transplantation
Patients with a variety of different types of cancerous tumors that have spread metastasized and whose conditions have not improved with stand therapy will be eligible to participate Those patients selected to participate in the study will undergo a procedure known as a mini-transplant The mini-transplant is a transplantation of stem-cells collected from a sibling brother or sister of the patient Unlike traditional bone marrow transplants the mini-transplant does not require intense chemotherapy or radiation therapy Because of this patients experience fewer and less severe side effects
This study is open to patients diagnosed with a variety of metastatic solid tumors including esophageal gastric stomach colon rectal liver tumors hepatoma cancer of the biliary system cholangiocarcinoma cancer of the pancreas lung breast prostate bone sarcoma adrenal basal cell bladder and adenocarcinomas of unk primary origin
Patients with a variety of different types of cancerous tumors that have spread metastasized and whose conditions have not improved with stand therapy will be eligible to participate Those patients selected to participate in the study will undergo a procedure known as a mini-transplant The mini-transplant is a transplantation of stem-cells collected from a sibling brother or sister of the patient Unlike traditional bone marrow transplants the mini-transplant does not require intense chemotherapy or radiation therapy Because of this patients experience fewer and less severe side effects
This study is open to patients diagnosed with a variety of metastatic solid tumors including esophageal gastric stomach colon rectal liver tumors hepatoma cancer of the biliary system cholangiocarcinoma cancer of the pancreas lung breast prostate bone sarcoma adrenal basal cell bladder and adenocarcinomas of unk primary origin
Detailed Description:
The main objective of this study is to identify metastatic neoplasms which may be susceptible to the GVT effect We will treat patients with progressive metastatic solid tumors refractory to standard therapy with a non-myeloablative allogeneic PBSC transplant from a family donor A GVT effect from immunocompetent donor immune cells could extend life expectancy and possibly cure such patients
Eligible patients will be treated with an allogeneic peripheral blood stem cell transplant from an HLA identical or single HLA antigen-mismatched family donor using an intensive immunosuppressive regimen without myeloablation mini-transplant in an attempt to decrease the transplant related toxicities while preserving the anti-malignancy andor anti-host marrow effect of the graft The low intensity non-myeloablative conditioning regimen should provide adequate immunosuppression to allow stem cell and lymphocyte engraftment A T-cell replete donor-derived granulocyte colony stimulating factor G-CSF-mobilized peripheral blood stem cells PBSC will be used to establish hematopoietic and lymphoid reconstitution We will infuse lymphocytes in patients with 100 donor T-cell chimerism or with evidence of tumor progression in an attempt to prevent graft rejection and enhance a graft-versus-malignancy effect respectively
This trial is open to several different types of metastatic treatment-refractory solid neoplasms breast cholangiocarcinoma small intestinecolonrectal adenocarcinoma esophagealgastric hepatocellular pancreatic prostate and bonysoft tissue sarcomas The trial design permits up to 10 patients with a specific tumor type to be enrolled to screen for anti-tumor effects A single complete response in a specific tumor type is an indication to exclude further patients with that diagnosis from the study Subsequently a new protocol which focuses on further defining a GVT effect in that disease category will be instituted
Eligible patients will be treated with an allogeneic peripheral blood stem cell transplant from an HLA identical or single HLA antigen-mismatched family donor using an intensive immunosuppressive regimen without myeloablation mini-transplant in an attempt to decrease the transplant related toxicities while preserving the anti-malignancy andor anti-host marrow effect of the graft The low intensity non-myeloablative conditioning regimen should provide adequate immunosuppression to allow stem cell and lymphocyte engraftment A T-cell replete donor-derived granulocyte colony stimulating factor G-CSF-mobilized peripheral blood stem cells PBSC will be used to establish hematopoietic and lymphoid reconstitution We will infuse lymphocytes in patients with 100 donor T-cell chimerism or with evidence of tumor progression in an attempt to prevent graft rejection and enhance a graft-versus-malignancy effect respectively
This trial is open to several different types of metastatic treatment-refractory solid neoplasms breast cholangiocarcinoma small intestinecolonrectal adenocarcinoma esophagealgastric hepatocellular pancreatic prostate and bonysoft tissue sarcomas The trial design permits up to 10 patients with a specific tumor type to be enrolled to screen for anti-tumor effects A single complete response in a specific tumor type is an indication to exclude further patients with that diagnosis from the study Subsequently a new protocol which focuses on further defining a GVT effect in that disease category will be instituted
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 99-H-0064 | None | None | None |