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Sponsored by: |
Hadassah Medical Organization |
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Information provided by: | Hadassah Medical Organization |
ClinicalTrials.gov Identifier: | NCT00855452 |
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.
Condition | Intervention | Phase |
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Metastatic Breast Cancer Malignant Melanoma Renal Cell Cancer Gastrointestinal Cancer |
Procedure: one - three cycles of cell therapy during 4-6 weeks (3-5x10^7 cells/kg will be given through IV systemically |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | rIL-2 Activated Allogeneic Lymphocytes for the Induction of Graft Versus Tumor Effect (GVT) in Metastatic Solid Tumors |
Estimated Enrollment: | 20 |
Study Start Date: | January 2009 |
Estimated Study Completion Date: | January 2011 |
Estimated Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 12 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Consenting patients (age 12-70) will be eligible for participation in the study involving anti-tumor immunotherapy provided the following criteria are met:
Evidence of cancer not expected to be cured with conventional modalities:
Pediatric patients: Chemotherapy-resistant neuroblastoma stage 4 & sarcomas. Adult patients: Metastatic breast cancer, malignant melanoma, renal cell cancer and selected cases of ovary cancer, gastrointestinal cancer, small-cell and non-small cell lung cancer with non-bulky metastatic disease, metastatic prostate cancer.
Exclusion Criteria:
Patients will be excluded from participation in the study if any of the following criteria are met:
Contact: Preuven Or, Prof., M.D. | 972-(2)-6776561 | reuvenor@hadassah.org.il |
Contact: Liliane Dray, RN | 972-(50)-8573250 | Lilane@hadassah.org.il |
Israel | |
Hadassah University Hospital | Recruiting |
Jerusalem, Israel, 91120 | |
Contact: Reuven Or, Prof., M.D. 972-(2)-6776551 reuvenor@hadassah.org.il | |
Contact: Liliane Dray, RN 972-(50)-8573250 Lilane@hadassah.org.il | |
Principal Investigator: Reuven Or, Prof., M.D. | |
Sub-Investigator: Igor B. Resnick, Prof., M.D.,Ph.D., D. Sci | |
Sub-Investigator: Michael Y Shapira, M.D. | |
Sub-Investigator: Bejumin Gesundheit, M.D. |
Principal Investigator: | Reuven Or, Prof., M.D. | Hadassah University Hospital |
Responsible Party: | Hadassah Medical Organization ( Prof. Reuven Or ) |
Study ID Numbers: | 0457-08-HMO-CTIL |
Study First Received: | February 19, 2009 |
Last Updated: | March 3, 2009 |
ClinicalTrials.gov Identifier: | NCT00855452 History of Changes |
Health Authority: | Israel: Ministry of Health |
GVL rIL-2(LAK) GVHD |
MST alloCT alloBMT |
Urinary Tract Neoplasm Gastrointestinal Diseases Urogenital Neoplasms Urologic Neoplasms Melanoma Renal Cancer Urologic Diseases Kidney Neoplasms Neoplasms, Germ Cell and Embryonal Nevus, Pigmented Neuroepithelioma Kidney Diseases Breast Diseases Morphine |
Kidney Cancer Digestive System Neoplasms Skin Diseases Breast Neoplasms Carcinoma Neuroendocrine Tumors Neuroectodermal Tumors Digestive System Diseases Carcinoma, Renal Cell Gastrointestinal Neoplasms Nevus Adenocarcinoma Neoplasms, Glandular and Epithelial |
Gastrointestinal Diseases Neoplasms, Nerve Tissue Urogenital Neoplasms Urologic Neoplasms Melanoma Neoplasms by Site Urologic Diseases Kidney Neoplasms Neoplasms, Germ Cell and Embryonal Nevi and Melanomas Kidney Diseases Breast Diseases Neoplasms by Histologic Type |
Digestive System Neoplasms Skin Diseases Breast Neoplasms Carcinoma Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms Digestive System Diseases Carcinoma, Renal Cell Gastrointestinal Neoplasms Adenocarcinoma Neoplasms, Glandular and Epithelial |