Combination Chemotherapy and Rituximab in Treating Patients With Newly Diagnosed AIDS-Related B-Cell Non-Hodgkin's Lymphoma
- Conditions
- Lymphoma
- Interventions
- Biological: filgrastimBiological: pegfilgrastimBiological: rituximabBiological: sargramostimOther: immunohistochemistry staining methodOther: laboratory biomarker analysis
- Registration Number
- NCT00389818
- Lead Sponsor
- AIDS Malignancy Consortium
- Brief Summary
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some find cancer cells and help kill them or carry cancer-killing substances to them. Others interfere with the ability of cancer cells to grow and spread. Giving combination chemotherapy together with rituximab may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving combination chemotherapy together with rituximab works in treating patients with newly diagnosed AIDS-related B-cell non-Hodgkin's lymphoma.
- Detailed Description
OBJECTIVES:
Primary
* Determine the complete response rate (complete response and complete response unconfirmed) in patients with newly diagnosed, AIDS-related B-cell non-Hodgkin's lymphoma treated with doxorubicin hydrochloride liposome, rituximab, cyclophosphamide, vincristine, and prednisone (DR-COP).
* Determine the duration of response (relapse-free survival) in patients treated with this regimen.
* Determine the median survival time of patients treated with this regimen.
* Determine rate of bacterial, fungal, and opportunistic infections in patients treated with this regimen.
Secondary
* Determine, preliminarily, the relationship between MDR-1 expression in tumor tissue and response to therapy in patients treated with this regimen.
* Determine, preliminarily, any relationship between response and survival and BCL-2 expression in tumor tissue in patients treated with this regimen.
* Determine any relationship between development of bacterial, fungal, and/or opportunistic infections and baseline CD4 lymphocyte count, HIV-1 RNA level, and quantitative immunoglobulin levels, or changes in quantitative immunoglobulin levels over time in patients treated with this regimen.
* Compare the results of positron emission tomography (PET) scanning with traditional CT scans in predicting response to therapy in these patients.
* Examine the relationship between chemotherapeutic drug levels and receipt of specific antiretroviral and/or anti-infective medications in these patients.
* Examine the mortality and the causes of death in patients treated with this regimen.
* Determine event-free survival at 1 year.
OUTLINE: This is a nonrandomized, multicenter study.
Patients receive doxorubicin hydrochloride liposome IV over 90 minutes, rituximab IV over 5-7 hours, cyclophosphamide IV over 1 hour, and vincristine IV over 1-2 minutes on day 1 and oral prednisone on days 1-5. Patients also receive filgrastim (G-CSF), sargramostim (GM-CSF), or pegfilgrastim beginning on day 3 and continuing until blood counts recover. Treatment repeats every 21-28 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.
Patients undergo laboratory/biomarker studies at baseline and after every 2 courses of chemotherapy. Tissue is examined by immunohistochemistry for BCL-2, Ki67, and MDR-1, along with other markers.
After completion of study treatment, patients are followed periodically for 3 years.
PROJECTED ACCRUAL: A total of 44 patients will be accrued for this study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 43
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description DR-COP filgrastim Single arm interventional study: all subjects receive DR-COP regimen. DR-COP pegfilgrastim Single arm interventional study: all subjects receive DR-COP regimen. DR-COP rituximab Single arm interventional study: all subjects receive DR-COP regimen. DR-COP sargramostim Single arm interventional study: all subjects receive DR-COP regimen. DR-COP cyclophosphamide Single arm interventional study: all subjects receive DR-COP regimen. DR-COP pegylated liposomal doxorubicin hydrochloride Single arm interventional study: all subjects receive DR-COP regimen. DR-COP prednisone Single arm interventional study: all subjects receive DR-COP regimen. DR-COP vincristine sulfate Single arm interventional study: all subjects receive DR-COP regimen. DR-COP immunohistochemistry staining method Single arm interventional study: all subjects receive DR-COP regimen. DR-COP laboratory biomarker analysis Single arm interventional study: all subjects receive DR-COP regimen.
- Primary Outcome Measures
Name Time Method Complete Response Rate (Complete Response and Complete Response Unconfirmed) Defined as Disappearance of All Evidence of Disease Based on Radiographic Findings on CT or MRI . After cycles 2, 4, 6, 1 month after treatment discontinuation, every 2 months for 1 year after treatment discontinuation, every 6 months during the second and third years after treatment discontinuation Duration of Response After cycles 2, 4, 6, 1 month after treatment discontinuation, every 2 months for 1 year after treatment discontinuation, every 6 months during the second and third years after treatment discontinuation Median Survival Time After cycles 2, 4, 6, 1 month after treatment discontinuation, every 2 months for 1 year after treatment discontinuation, every 6 months during the second and third years after treatment discontinuation Rate of Bacterial, Fungal, and Opportunistic Infections After every cycle of treatment, 1 month after treatment discontinuation, every 2 months for 1 year after treatment discontinuation, every 6 months during the second and third years after treatment discontinuation
- Secondary Outcome Measures
Name Time Method Relationship Between Response and Survival and BCL-2 Expression in Tumor Tissue Baseline, after cycles 4 and 6, 1 month after treatment discontinuation Relationship Between MDR-1 Expression and Response to Treatment Baseline Relationship Between Development of Bacterial, Fungal, and/or Opportunistic Infections and Baseline CD4 Lymphocyte Count, HIV-1 RNA Level, and Quantitative Immunoglobin Level, or Changes in Quantitative Immunoglobin Levels Over Time After every cycle of treatment, 1 month after treatment discontinuation, every 2 months for 1 year after treatment discontinuation, every 6 months during the second and third years after treatment discontinuation Mortality and Cause of Death At any time through the third year after treatment discontinuation Event-free Survival at 1 Year 1 year post-treatment
Trial Locations
- Locations (14)
UCLA Clinical AIDS Research and Education (CARE) Center
🇺🇸Los Angeles, California, United States
Joan Karnell Cancer Center at Pennsylvania Hospital
🇺🇸Philadelphia, Pennsylvania, United States
Virginia Mason Medical Center
🇺🇸Seattle, Washington, United States
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
🇺🇸Saint Louis, Missouri, United States
USC/Norris Comprehensive Cancer Center and Hospital
🇺🇸Los Angeles, California, United States
Ochsner Cancer Institute at Ochsner Clinic Foundation
🇺🇸New Orleans, Louisiana, United States
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
🇺🇸Chicago, Illinois, United States
Boston University Cancer Research Center
🇺🇸Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
Albert Einstein Cancer Center at Albert Einstein College of Medicine
🇺🇸Bronx, New York, United States
Case Comprehensive Cancer Center
🇺🇸Cleveland, Ohio, United States
University of Miami Sylvester Comprehensive Cancer Center - Miami
🇺🇸Miami, Florida, United States
Rebecca and John Moores UCSD Cancer Center
🇺🇸La Jolla, California, United States
Memorial Sloan-Kettering Cancer Center
🇺🇸New York, New York, United States