Seattle, Washington 98109


Purpose:

OBJECTIVES: I. Determine the safety of total body irradiation and post-transplant cyclosporine and mycophenolate mofetil in high-risk patients with human immunodeficiency virus-1. II. Determine whether this regimen results in stable mixed donor lymphocyte chimerism (5-95% donor CD3) in this patient population. III. Determine the kinetics of immune reconstruction following this treatment regimen in this patient population. IV. Determine the effect of this treatment regimen on viral load in this patient population.


Study summary:

PROTOCOL OUTLINE: Patients receive oral or IV cyclosporine 2-3 times daily on Days -1 to 50. Patients undergo total body irradiation followed by allogeneic peripheral blood stem cell or bone marrow transplantation on Day 0 (assuming donor is available). Beginning within 6 hours of transplantation, patients receive oral mycophenolate mofetil every 12 hours until Day 27. Patients with an unstable level of chimerism may receive 1-2 donor lymphocyte infusions. Patients are followed at Days 14, 28, 56, 80, 180, and 360.


Criteria:

PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Diagnosis of human immunodeficiency virus-1 not responsive to highly active antiretroviral therapy (HAART); treated with HAART for at least the past 6 months; viral load less than 50 copies/mL plasma; CD4 count less than 100/mm3 - Lymphoma or other HIV-associated malignancy allowed with the following criteria: malignancy is in complete remission or very good partial remission, defined as a significant reduction of disease with therapy and no evidence of continued tumor growth; viral load has decreased by at least 1.5 logs OR to less than 5,000 copies/mL plasma while on HAART; CD4 count is allowed to be greater than 100/mm3 - HLA genotypically identical donor available (under 75 years of age) --Prior/Concurrent Therapy-- - No concurrent growth factors during mycophenolate mofetil administration; concurrent continuation of anti-retroviral therapy required --Patient Characteristics-- - Life expectancy: At least 30 days - Other: No positive serology for Toxoplasma gondii; no other disease or organ dysfunction that would preclude survival; not pregnant or nursing; fertile patients must use effective contraception during and for 1 year after study


NCT ID:

NCT00010348


Primary Contact:

Study Chair
Ann Woolfrey
Fred Hutchinson Cancer Research Center


Backup Contact:

N/A


Location Contact:

Seattle, Washington 98109
United States

Ann Woolfrey
Phone: 206-667-4453

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: September 22, 2017

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

This study is not currently recruiting Study Participants on ClinicalConnection.com. The form below is not enabled.