Ignite Creation Date:
2024-05-05 @ 9:16 PM
Last Modification Date:
2024-10-26 @ 10:02 AM
Study NCT ID:
NCT00855452
Status:
COMPLETED
Last Update Posted:
2015-06-11
First Post:
2009-02-19
Brief Title:
Activated Allogeneic Lymphocytes for Induction Graft Versus Tumor Effect in Metastatic Solid Tumors
Sponsor:
Hadassah Medical Organization
Organization:
Hadassah Medical Organization
Study Overview
Official Title:
rIL-2 Activated Allogeneic Lymphocytes for the Induction of Graft Versus Tumor Effect GVT in Metastatic Solid Tumors
Status:
COMPLETED
Status Verified Date:
2008-10
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:
rIL-2LAK
Brief Summary:
The present protocol is a phase 2 study designed to investigate the potential application of allogeneic cell-mediated immunotherapy in metastatic solid tumors similarly to the well established graft versus leukemia GVL effects in patients with metastatic solid tumors resistant to conventional treatment modalities Patients will be eligible to participate in a treatment program based on systemic administration of mismatched lymphocytes activated in vitro with rIL-2 LAK followed by rIL-2 inoculation in vivo This treatment is aiming to induce an anti-tumor effect mediated by the efficient killing activity of the rIL-2 activated cells Prior to cell infusion patients will receive the conditioning treatment with low dose Cyclophosphamide Cyc or Fludarabine with 2 injections of low dose alpha interferon Cell therapy will be combined with specific anti-tumor monoclonal antibodies if available for the specific disease Further activation of the anti-tumor activity of alloreactive donor T cells and natural killer NK cells will be accomplished by in vivo inoculation of rIL-2 aiming for enhancing the anti-cancer potential of donor-derived effectors cells Patients will receive one - three cycles of cell therapy as long as there are no signs of Graft- versus - Host - disease GVHD and the malignant disease is controlled
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None