Immunotherapy in Treating Patients Who Are Undergoing Bone Marrow or Peripheral Stem Cell Transplantation

This study has been completed.
Sponsor:
Information provided by:
Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier:
NCT00002673
First received: November 1, 1999
Last updated: June 15, 2010
Last verified: June 2010
  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 2

Study Type: Interventional
Study Design: Primary Purpose: Supportive Care
Official Title: A PHASE II STUDY OF CELLULAR ADOPTIVE IMMUNOTHERAPY AS PROPHYLAXIS FOR CYTOMEGALOVIRUS DISEASE AFTER ALLOGENEIC BONE MARROW TRANSPLANTATION

Resource links provided by NLM:


Further study details as provided by Fred Hutchinson Cancer Research Center:

Estimated Enrollment: 30
Study Start Date: June 1995
Study Completion Date: February 2002
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00002673     History of Changes
Other Study ID Numbers: 1011.01, FHCRC-1011.01, NCI-V95-0702, CDR0000064307
Study First Received: November 1, 1999
Last Updated: June 15, 2010
Health Authority: United States: Federal Government
United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Fred Hutchinson Cancer Research Center:
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

ClinicalTrials.gov processed this record on October 23, 2014