Cell Therapy of Cancer With Allogeneic Blood Lymphocytes Activated With Recombinant Interleukin-2 (rIL-2) for Metastatic Solid Tumors
Recruitment status was: Recruiting
The present protocol is 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 hematologic malignancies.
Patients with metastatic solid tumors resistant to conventional modalities will be eligible to participate in a treatment program based on the administration of non-myeloablative immunotherapy (i.e. fludarabine, Cytoxan) followed by interferon injections; subsequently the patients will be treated with mismatched alloreactive donor lymphocytes activated in vitro and in vivo with rIL-2. The aim of this study is based on the recognition of foreign tumor cell surface alloantigens.
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
|Official Title:||Tumor-Selective and Systemic Cell Therapy of Cancer With Allogeneic Blood Lymphocytes Activated With rIL-2 and Non-Myeloablative Stem Cell Transplantation|
- Study the feasibility, toxicity, and response rate of allogeneic cell therapy induced by selective intra-lesional and systemic administration of mismatched alloreactive lymphocytes in patients with metastatic cancer
- Study the feasibility, toxicity, and response to treatment with allogeneic mini-transplant using sibling donors in patients with metastatic cancer
|Study Start Date:||December 1996|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00149006
|Hadassah Medical Organization|
|Jerusalem, Israel, 91120|
|Principal Investigator:||Shimon Slavin, MD||Hadassah Medical Organization|
|Study Director:||Reuven Or, MD||Hadassah Medical Organization|