Antiviral Therapy Plus Either Peripheral Stem Cell or Umbilical Cord Blood Transplantation in Treating Patients Who Are HIV Positive and Have Hematologic Cancer
|ClinicalTrials.gov Identifier: NCT00003435|
Recruitment Status : Withdrawn
First Posted : June 9, 2004
Last Update Posted : March 7, 2013
RATIONALE: Antiviral agents are drugs that act against viruses and may be an effective treatment for HIV. Peripheral stem cell transplantation or umbilical cord blood transplantation may be able to replace immune cells that were destroyed by chemotherapy and radiation therapy used to kill tumor cells. Combining either umbilical cord blood transplantation or peripheral stem cell transplantation with antiviral therapy may be an effective treatment for HIV-positive patients who have hematologic cancer.
PURPOSE: Phase I trial to study the effectiveness of antiviral therapy plus either peripheral stem cell transplantation or umbilical cord blood transplantation in treating HIV-positive patients who have refractory or recurrent hematologic cancer.
|Condition or disease||Intervention/treatment||Phase|
|Leukemia Lymphoma||Biological: anti-thymocyte globulin Drug: melphalan Procedure: antiviral therapy Procedure: bone marrow ablation with stem cell support Procedure: peripheral blood stem cell transplantation Procedure: umbilical cord blood transplantation Radiation: radiation therapy||Phase 1|
OBJECTIVES: I. Determine the feasibility and safety of combination antiretroviral therapy followed by HLA matched sibling peripheral blood stem cell or unrelated umbilical cord blood transplants in HIV infected adults with hematologic malignancies. II. Measure the effects of this treatment on HIV viral burden in the serum and tissues of these patients. III. Measure immune reconstitution following treatment in this patient population.
OUTLINE: Patients receive a combination of 3 antiretroviral agents beginning at least 3 weeks prior to the initiation of the myeloablative conditioning regimen. The antiretroviral agents are discontinued on days -5 to -1 prior to transplant. Beginning on day 0 the antiretroviral agents are restarted and continue indefinitely. Patients who are given umbilical cord blood (UCB) transplants undergo collection of autologous peripheral blood stem cells (PBSC) prior to the myeloablative conditioning regimen in case there is UCB graft failure. Prior to PBSC or UCB transplantation on day 0, all patients receive a myeloablative conditioning regimen. The conditioning regimen consists of total body irradiation twice a day on days -9 to -5 and melphalan IV over 60 minutes on days -4 to -2. Patients receiving UCB transplant also receive anti-thymocyte globulin over 6 hours on days -3 to -1. Patients are followed every 3 months for 3 years, then annually for the next 3 years.
PROJECTED ACCRUAL: A total of 6 patients will be accrued for this study over 2 years.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Official Title:||A Pilot Study Involving Administration of Combination Anti-Retroviral Therapy and Transplantation of HLA-Matched Sibling Peripheral Blood Stem Cells or Partially HLA-Matched Unrelated Umbilical Cord Blood In Adults With HIV Infection and Hematologic Malignancies|
|Study Start Date :||May 1998|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003435
|United States, North Carolina|
|Duke Comprehensive Cancer Center|
|Durham, North Carolina, United States, 27710|
|Study Chair:||Clayton Smith, MD||Duke Cancer Institute|