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Sponsors and Collaborators: |
Fred Hutchinson Cancer Research Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00068718 |
RATIONALE: White blood cells from donors may be able to kill cancer cells and prevent disease progression or relapse in patients who have undergone allogeneic bone marrow transplantation or allogeneic stem cell transplantation.
PURPOSE: This phase I/II trial is studying the side effects of donor lymphocyte infusion and to see how well it works in treating patients with persistent, relapsed, or progressing cancer after allogeneic bone marrow transplantation or stem cell transplantation.
Condition | Intervention | Phase |
---|---|---|
Chronic Myeloproliferative Disorders Graft Versus Host Disease Kidney Cancer Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Diseases Neuroblastoma Ovarian Cancer Sarcoma Testicular Germ Cell Tumor |
Drug: therapeutic allogeneic lymphocytes |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Donor Lymphocyte Infusion for the Treatment of Malignancy After Hematopoietic Cell Transplantation Using Nonmyeloablative Conditioning - A Multi-Center Trial |
Estimated Enrollment: | 100 |
Study Start Date: | May 2003 |
Estimated Primary Completion Date: | May 2011 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter, dose-escalation study.
Patients receive unirradiated (viable) donor lymphocyte infusion (DLI) over 15-30 minutes on day 0. Patients may receive a second infusion after 4 weeks if no graft-versus-host disease (GVHD) develops and disease worsens, or after 8 weeks if disease status is unchanged and persistent donor T cells are documented.
To determine the safety of this regimen, all patients receive a standard initial dose of DLI and then, among patients requiring a second treatment, cohorts of 5-25 patients receive decreasing doses of DLI. Acceptable safety is determined by the regimen during which no more than 15% of patients experience morbid GVHD.
Patients are followed every 2 months for 6 months, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 5-100 patients will be accrued for this study.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
United States, Oregon | |
Oregon Health and Science University Cancer Institute | Recruiting |
Portland, Oregon, United States, 97239-3098 | |
Contact: Clinical Trials Office - Oregon Health and Science University 503-494-1080 trials@ohsu.edu | |
United States, Washington | |
Fred Hutchinson Cancer Research Center | Recruiting |
Seattle, Washington, United States, 98109-1024 | |
Contact: Brenda Sandmaier, MD 206-667-4961 | |
Seattle Cancer Care Alliance | Recruiting |
Seattle, Washington, United States, 98109-1023 | |
Contact: Clinical Trials Office - Seattle Cancer Care Alliance 800-804-8824 | |
University of Washington School of Medicine | Recruiting |
Seattle, Washington, United States, 98195 | |
Contact: Clinical Trials Office - University of Washington School of Me 206-616-8289 | |
Veterans Affairs Medical Center - Seattle | Recruiting |
Seattle, Washington, United States, 98108 | |
Contact: Thomas R. Chauncey, MD, PhD 206-762-1010 | |
United States, Wisconsin | |
Medical College of Wisconsin Cancer Center | Recruiting |
Milwaukee, Wisconsin, United States, 53226 | |
Contact: Clinical Trials Office - Medical College of Wisconsin Cancer C 414-805-4380 | |
Germany | |
Universitaet Leipzig | Recruiting |
Leipzig, Germany, D-04103 | |
Contact: Dietger Niederwieser, MD 49-341-971-3050 dietger@medizin.uni_leipzig.de | |
Italy | |
Azienda Sanitaria Ospedale San Giovanni Battista Molinette di Torino | Recruiting |
Turin, Italy, 10126 | |
Contact: Benedetto Bruno, MD, PhD 39-339-112-9064 benedetto.bruno@unito.it |
Principal Investigator: | Brenda Sandmaier, MD | Fred Hutchinson Cancer Research Center |
Responsible Party: | Fred Hutchinson Cancer Research Center ( Brenda Sandmaier ) |
Study ID Numbers: | CDR0000327819, FHCRC-1803.00 |
Study First Received: | September 10, 2003 |
Last Updated: | December 31, 2008 |
ClinicalTrials.gov Identifier: | NCT00068718 |
Health Authority: | Unspecified |
graft versus host disease recurrent adult diffuse large cell lymphoma recurrent adult diffuse mixed cell lymphoma recurrent adult diffuse small cleaved cell lymphoma recurrent adult Burkitt lymphoma recurrent adult Hodgkin lymphoma recurrent adult immunoblastic large cell lymphoma recurrent adult lymphoblastic lymphoma recurrent cutaneous T-cell non-Hodgkin lymphoma recurrent grade 1 follicular lymphoma recurrent grade 2 follicular lymphoma recurrent grade 3 follicular lymphoma recurrent mantle cell lymphoma recurrent neuroblastoma recurrent ovarian epithelial cancer |
recurrent ovarian germ cell tumor recurrent malignant testicular germ cell tumor refractory chronic lymphocytic leukemia refractory hairy cell leukemia relapsing chronic myelogenous leukemia recurrent adult acute lymphoblastic leukemia recurrent adult acute myeloid leukemia previously treated myelodysplastic syndromes recurrent childhood acute lymphoblastic leukemia recurrent childhood acute myeloid leukemia recurrent/refractory childhood Hodgkin lymphoma refractory multiple myeloma chronic idiopathic myelofibrosis recurrent Wilms tumor and other childhood kidney tumors recurrent childhood rhabdomyosarcoma |
Chronic myelogenous leukemia Malignant mesenchymal tumor Hodgkin lymphoma, adult Lymphoma, small cleaved-cell, diffuse Urogenital Neoplasms Lymphoma, large-cell, immunoblastic Preleukemia Hemorrhagic Disorders Neuroepithelioma Kidney Diseases Rhabdomyosarcoma Endocrine Gland Neoplasms Myelodysplastic syndromes Precursor Cell Lymphoblastic Leukemia-Lymphoma Hematologic Diseases |
Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative Blood Coagulation Disorders Genital Neoplasms, Female Acute myelogenous leukemia Testicular Neoplasms Leukemia, Myeloid Carcinoma Myelodysplastic myeloproliferative disease B-cell lymphomas Sarcoma Lymphoma, Non-Hodgkin Hairy cell leukemia Neoplasms, Glandular and Epithelial Precancerous Conditions Blood Protein Disorders |
Neoplasms Pathologic Processes Disease Neoplasms by Site Neoplasms by Histologic Type Immune System Diseases |
Syndrome Neoplasms, Nerve Tissue Cardiovascular Diseases Neoplasms, Neuroepithelial Adnexal Diseases |