Carmustine, Etoposide, Cyclophosphamide, and Stem Cell Transplant in Treating Patients With HIV-Associated Lymphoma
RATIONALE: Giving high-dose chemotherapy drugs, such as carmustine, etoposide, and cyclophosphamide, before a peripheral blood stem cell transplant stops the growth of cancer cells by stopping them from dividing or killing them. After treatment, stem cells that were collected from the patient's blood are returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy.
PURPOSE: This clinical trial is studying the side effects of giving high-dose carmustine, etoposide, and cyclophosphamide together with a stem cell transplant and to see how well it works in treating patients with HIV-associated lymphoma.
Other: pharmacological study
Procedure: autologous hematopoietic stem cell transplantation
Procedure: peripheral blood stem cell transplantation
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||High Dose Chemotherapy and Combination Anti-HIV Therapy for HIV-Associated Hodgkin's and Non-Hodgkin's Lymphoma|
- Number of days to engraftment as defined by the standard operating procedures of the department of biostatistics at the City of Hope [ Time Frame: Day 100 post stem cell reinfusion ] [ Designated as safety issue: No ]
- Feasibility and treatment-associated toxicity of this regimen [ Time Frame: 1 year post stem cell reinfusion ] [ Designated as safety issue: Yes ]
- Ability to mobilize adequate numbers of peripheral blood stem cells (2.5 x 10e6 CD34+cells) [ Time Frame: At the completion of stem cell collection ] [ Designated as safety issue: No ]
- Disease-free and overall survival [ Time Frame: 2 years post stem cell reinfusion ] [ Designated as safety issue: No ]
- HIV viral load, CD4+/CD8+ counts, and immune recovery [ Time Frame: 2 years post stem cell reinfusion ] [ Designated as safety issue: No ]
|Study Start Date:||May 2000|
|Estimated Primary Completion Date:||October 2016 (Final data collection date for primary outcome measure)|
Experimental: Treatment (high-dose chemotherapy, anti-HIV therapy)
Patients undergo leukapheresis to obtain PBSCs for transplantation. At least 5 days later, patients with an adequate number of collected cells proceed to high-dose chemotherapy. Patients receive carmustine IV over 4 hours on days -7 to -5, etoposide IV over 4 hours on day -4, and cyclophosphamide IV on day -2. Patients receive an autologous PBSC infusion on day 0.
150 mg/m2 day -7, -6,and -5 prior to stem cell reinfusionDrug: cyclophosphamide
100 mg/kg on day -2 prior to stem cell reinfusionDrug: etoposide
60 mg/kg on day -4 prior to stem cell reinfusionOther: pharmacological study
Prior to start of etoposide infusion, 2 hours after start of infusion, just prior to the end of infusion, then at 0.5, 1, 2, 4, 24 and 48 hours after the end of infusionProcedure: autologous hematopoietic stem cell transplantation
Reinfusion of autologous stem cellsProcedure: peripheral blood stem cell transplantation
Reinfusion of autologous stem cells
- To evaluate the feasibility and toxicity of high-dose chemotherapy comprising carmustine, etoposide, and cyclophosphamide followed by autologous stem cell infusion in patients with HIV-associated lymphoma receiving combination anti-HIV therapy and to determine the efficiency of stem cell collection from these patients.
- To estimate the disease-free and overall survival of patients treated with this regimen.
- To evaluate HIV viral load, CD+4/CD+8 counts, and immune recovery after high-dose anti- lymphoma chemotherapy.
- To determine the pharmacokinetics of high-dose etoposide in patients receiving highly active anti-retroviral therapy (HAART).
OUTLINE: Patients undergo leukapheresis to obtain peripheral blood stem cells (PBSCs) for transplantation. At least 5 days later, patients with an adequate number of collected cells proceed to high-dose chemotherapy.
- High-dose chemotherapy: Patients receive carmustine IV over 4 hours on days -7 to -5, etoposide IV over 4 hours on day -4, and cyclophosphamide IV on day -2.
- Autologous PBSC transplantation: Patients receive PBSC infusion on day 0. Patients undergo blood sample collection periodically for pharmacokinetic studies of etoposide.
After completion of study treatment, patients are followed at approximately 30 days and 100 days, every 3 months for 1 year, every 6 months for 1 year, and then annually thereafter.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00641381
|United States, California|
|City of Hope Medical Center|
|Duarte, California, United States, 91010-3000|
|Principal Investigator:||Amrita Y. Krishnan, MD||City of Hope Medical Center|