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Sponsored by: |
Fred Hutchinson Cancer Research Center |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00002673 |
RATIONALE: White blood cells from donors who have been exposed to cytomegalovirus may be able to help prevent this infection from occurring in patients who are undergoing bone marrow or peripheral stem cell transplantation.
PURPOSE: Phase II trial to study the effectiveness of donated white blood cells to prevent cytomegalovirus infection in patients who are undergoing bone marrow or peripheral stem cell transplantation.
Condition | Intervention | Phase |
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Cancer |
Procedure: infection prophylaxis and management |
Phase II |
Study Type: | Interventional |
Study Design: | Supportive Care |
Official Title: | A PHASE II STUDY OF CELLULAR ADOPTIVE IMMUNOTHERAPY AS PROPHYLAXIS FOR CYTOMEGALOVIRUS DISEASE AFTER ALLOGENEIC BONE MARROW TRANSPLANTATION |
Estimated Enrollment: | 30 |
Study Start Date: | June 1995 |
OBJECTIVES: I. Determine whether adoptive immunotherapy comprising donor-derived CD8+, CMV-specific, major histocompatibility complex class I-restricted cytotoxic T-lymphocyte (CTL) clones (CD8+ CMV-specific CTL clones) and CD4+ CMV-specific T-helper (Th)-cell clones is effective in preventing CMV viremia and disease in CMV-positive patients with malignancies requiring allogeneic bone marrow or peripheral blood stem cell transplantation. II. Determine whether the transfer of CD4+ CMV-specific Th-cell clones to patients with deficient responses can reconstitute CD4+ Th-cell activity and augment adoptively transferred CD8+ CMV-specific CTL clones.
OUTLINE: Allogeneic CD8+ CMV-specific, major histocompatibility complex class I-restricted cytotoxic T-lymphocyte (CTL) clones (CD8+ CMV-specific CTL clones) and CD4+ CMV-specific T-helper (Th)-cell clones are harvested and cultured in vitro at least 2 weeks before bone marrow or peripheral blood stem cell (PBSC) transplantation. Bone marrow or PBSC are infused on day 0. Patients receive the first infusion of CD8+ CMV-specific CTL clones beginning between days 28 and 45 posttransplantation, followed 8 days later by the second infusion, followed 2 days later by the first infusion of CD4+ CMV-specific Th-cell clones. Patients who receive prednisone posttransplantation or have deficient CD8+ CTL responses (i.e., less than 50% of the response measured in the immunocompetent bone marrow donor) after the second infusion of CD8+ CMV-specific CTL clones receive a third infusion of CD8+ CMV-specific CTL clones and a second infusion of CD4+ CMV-specific Th-cell clones before day 67.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within 12-18 months.
Ages Eligible for Study: | 12 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: See General Eligibility Criteria
PATIENT CHARACTERISTICS: See General Eligibility Criteria
PRIOR CONCURRENT THERAPY: See Disease Characteristics --Patients Characteristics-- Age: 12 to 60 Performance status: Not specified Hematopoietic: See Disease Characteristics Hepatic: Not specified Renal: Not specified
United States, Washington | |
Fred Hutchinson Cancer Research Center | |
Seattle, Washington, United States, 98109 |
Study Chair: | Stan Riddell, MD | Fred Hutchinson Cancer Research Center |
Study ID Numbers: | CDR0000064307, FHCRC-1011.01, NCI-V95-0702 |
Study First Received: | November 1, 1999 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00002673 |
Health Authority: | United States: Federal Government |
stage IV breast cancer stage IIIA breast cancer stage IIIB breast cancer recurrent childhood acute lymphoblastic leukemia recurrent adult Hodgkin lymphoma recurrent cutaneous T-cell non-Hodgkin lymphoma recurrent childhood rhabdomyosarcoma stage II ovarian epithelial cancer stage III ovarian epithelial cancer stage IV ovarian epithelial cancer recurrent ovarian epithelial cancer disseminated neuroblastoma recurrent neuroblastoma recurrent Wilms tumor and other childhood kidney tumors stage I multiple myeloma |
stage II multiple myeloma stage III multiple myeloma recurrent childhood lymphoblastic lymphoma stage III chronic lymphocytic leukemia stage IV chronic lymphocytic leukemia recurrent childhood acute myeloid leukemia recurrent adult acute myeloid leukemia recurrent adult acute lymphoblastic leukemia refractory chronic lymphocytic leukemia stage III malignant testicular germ cell tumor recurrent malignant testicular germ cell tumor chronic phase chronic myelogenous leukemia accelerated phase chronic myelogenous leukemia blastic phase chronic myelogenous leukemia adult acute myeloid leukemia in remission |
Blast Crisis Chronic myelogenous leukemia Hodgkin lymphoma, adult Lymphoma, Mantle-Cell Lymphoma, small cleaved-cell, diffuse Seminoma Ovarian epithelial cancer Small non-cleaved cell lymphoma Lymphoma, large-cell, immunoblastic Preleukemia Multiple myeloma Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Promyelocytic, Acute Neoplasm Metastasis Acute myeloid leukemia, adult |
Hodgkin Disease Rhabdomyosarcoma Chronic lymphocytic leukemia Myelodysplastic syndromes Lymphoma, Large B-Cell, Diffuse Precursor Cell Lymphoblastic Leukemia-Lymphoma Immunoproliferative Disorders Leukemia, B-cell, chronic Acute promyelocytic leukemia Acute myelogenous leukemia Breast Neoplasms Renal cancer Leukemia, Myeloid Testicular Neoplasms Carcinoma |
Neoplasms Neoplasms by Histologic Type Immune System Diseases |