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Immunotherapy in Treating Patients Who Are Undergoing Bone Marrow or Peripheral Stem Cell Transplantation
This study is ongoing, but not recruiting participants.
Sponsored by: Fred Hutchinson Cancer Research Center
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00002673
  Purpose

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
Cancer
Procedure: infection prophylaxis and management
Phase II

Genetics Home Reference related topics: breast cancer
MedlinePlus related topics: Bone Marrow Transplantation Cancer Cytomegalovirus Infections Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood Lymphoma Multiple Myeloma
U.S. FDA Resources
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

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 30
Study Start Date: June 1995
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   12 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002673

Locations
United States, Washington
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109
Sponsors and Collaborators
Fred Hutchinson Cancer Research Center
Investigators
Study Chair: Stan Riddell, MD Fred Hutchinson Cancer Research Center
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

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

Keywords provided by National Cancer Institute (NCI):
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

Study placed in the following topic categories:
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

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Immune System Diseases

ClinicalTrials.gov processed this record on January 14, 2009