Carmustine, Etoposide, Cyclophosphamide, and Stem Cell Transplant in Treating Patients With HIV-Associated Lymphoma
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|ClinicalTrials.gov Identifier: NCT00641381|
Recruitment Status : Active, not recruiting
First Posted : March 24, 2008
Last Update Posted : July 26, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma||Drug: carmustine Drug: cyclophosphamide Drug: etoposide Other: pharmacological study Procedure: autologous hematopoietic stem cell transplantation Procedure: peripheral blood stem cell transplantation||Phase 1|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||High Dose Chemotherapy and Combination Anti-HIV Therapy for HIV-Associated Hodgkin's and Non-Hodgkin's Lymphoma|
|Actual Study Start Date :||May 10, 2000|
|Estimated Primary Completion Date :||October 2018|
|Estimated Study Completion Date :||October 2018|
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 reinfusion
100 mg/kg on day -2 prior to stem cell reinfusion
60 mg/kg on day -4 prior to stem cell reinfusion
Other: 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 infusion
Procedure: autologous hematopoietic stem cell transplantation
Reinfusion of autologous stem cells
Procedure: peripheral blood stem cell transplantation
Reinfusion of autologous stem cells
- 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 ]
- Feasibility and treatment-associated toxicity of this regimen [ Time Frame: 1 year post stem cell reinfusion ]
- 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 ]
- Disease-free and overall survival [ Time Frame: 2 years post stem cell reinfusion ]
- HIV viral load, CD4+/CD8+ counts, and immune recovery [ Time Frame: 2 years post stem cell reinfusion ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|