EPOCH and Rituximab to Treat Non-Hodgkin's Lymphoma in Patients With HIV Infection
This study is currently recruiting participants.
Verified October 2012 by National Institutes of Health Clinical Center (CC)
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )
First received: November 3, 2000
Last updated: May 1, 2013
Last verified: October 2012
- 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.
- 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.
-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.
- 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 chemotherapy begins and is restarted when EPOCH-R treatment ends.
- Patients are monitored for treatment response with blood tests and imaging scans at baseline, when treatment ends, 2 months after treatment ends and then every 3 to 6 months for a total of 24 months following chemotherapy.
AIDS Related Lymphoma
Drug: doxorubicin hydrochloride
Drug: vincristine sulfate
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Short-Course EPOCH-Rituximab for Untreated CD-20+ HIV-Associated Lymphomas|
Resource links provided by NLM:
Drug Information available for: Cyclophosphamide Vincristine sulfate Doxorubicin Doxorubicin hydrochloride Etoposide Etoposide phosphate Filgrastim Lenograstim Granulocyte colony-stimulating factor RituximabU.S. FDA Resources
Further study details as provided by National Institutes of Health Clinical Center (CC):
Primary Outcome Measures:
- Progression-free survival at 1 year after completion of study treatment [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Toxicity during and 1 year after completion of study treatment. [ Designated as safety issue: Yes ]
- Response rate and duration at completion of study treatment and 5 years later. [ Designated as safety issue: No ]
- Ability of positron emission tomography (PET) scans to predict freedom from relapse at completion of study treatment and 5 years later. [ Designated as safety issue: No ]
- Effects of short course etoposide, vincristine, cyclophosphamide, doxorubicin, and rituximab (SC-EPOCH-R) on CD4 cell depletion and recovery at completion of study treatment and 18 months later. [ Designated as safety issue: No ]
- Response to antiretroviral therapy following SC-EPOCH-R 18 months after completion of study treatment. [ Designated as safety issue: No ]
|Study Start Date:||October 2000|
|Estimated Study Completion Date:||March 2018|
|Estimated Primary Completion Date:||March 2018 (Final data collection date for primary outcome measure)|
Intervention Details:Show Detailed Description
N/ADrug: doxorubicin hydrochloride
N/ADrug: vincristine sulfate
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00006436
|Contact: Margaret Shovlin, R.N.||(301) email@example.com|
|Contact: Wyndham H Wilson, M.D.||(301) firstname.lastname@example.org|
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact National Cancer Institute Referral Office (888) NCI-1937|
Sponsors and Collaborators
|Principal Investigator:||Wyndham H Wilson, M.D.||National Cancer Institute (NCI)|