Clinical Trial: EPOCH and Rituximab to Treat Non-Hodgkin's Lymphoma in Patients With HIV Infection

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Short-Course EPOCH-Rituximab in Untreated CD-20+ HIV-Associated Lymphomas

Brief Summary:

Background:

• HIV-infected patients have a weakened immune system, and chemotherapy, which is used to treat lymphoma, probably causes further damage to the immune system.
• Limiting the amount of immune damage due to chemotherapy might decrease the number of infections and the risk of developing cancer in the future in HIV-infected patients with non-Hodgkin's lymphoma.

Objectives:

• To determine whether reducing the total amount of chemotherapy using a specific combination of drugs called EPOCH-R (etoposide, doxorubicin, vincristine, cyclophosphamide and rituximab) will rid the body of lymphoma quickly while decreasing the risk of infections and future cancers.
• To determine whether the lymphoma will remain undetectable for at least one year if treatment is stopped one cycle after the patient enters remission.

Eligibility:

-Patients with non-Hodgkin's lymphoma and HIV infection 4 years of age and older who have not been treated previously with rituximab or cytotoxic chemotherapy.

Design:

• Patients receive EPOCH-R in 3-week treatment cycles for at least three and no more than six cycles.
• The lymphoma is evaluated using CT and PET scans at the end of treatment cycles 2 and 3. A bone marrow biopsy is repeated after cycle 2 if a biopsy was initially positive on screening for participation in the study.
• Anti-HIV therapy is stopped before chemoth
  

  Detailed Summary:

  Background:

  This is a study to investigate in a preliminary fashion the feasibility of short course chemotherapy to patients with HIV-associated non-Hodgkin's lymphoma (HIV-NHL).

  This study will investigate if the paradigm for treatment can be successfully changed from a standard of 6 cycles to one cycle beyond complete remission with 6 total allowable cycles.

  Objective:

  To assess with 90 percent probability that at least 50 percent of patients treated with short-course EPOCH-R will be progression free at one year.

  Eligibility:

  Aggressive CD20 positive DLBCL.

  HIV+ serology.

  All stages (I-IV) of disease.

  ECOG Performance status 0-4.

  NHL previously untreated with cytotoxic chemotherapy.

  Age greater than or equal to 18 years.

  May not be pregnant or nursing.

  May not have received previous rituximab.

  Design:

  Patients will be treated every three weeks with a combination of EPOCH and rituximab for one cycle beyond CR/CRu by CT scan of all detectable tumors for a minimum of three and maximum of six cycles. Following cycle 2, CT, positron emission tomography scans (PET), and bone marrow biopsies (if initially positive) will be performed.

  At the
  Sponsor: National Cancer Institute (NCI)
  

  Current Primary Outcome: Progression-free survival at 1 year after completion of study treatment [ Time Frame: Time of progressive disease ]
  
  

  Original Primary Outcome:
  
  

  Current Secondary Outcome:
  
  

  Original Secondary Outcome:
  
  Information By: National Institutes of Health Clinical Center (CC)
  

  Dates:
  Date Received: November 3, 2000
  Date Started: October 30, 2000
  Date Completion: March 31, 2021
  Last Updated: May 12, 2017
  Last Verified: December 29, 2016