Description:
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 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.
Title
- Brief Title: EPOCH and Rituximab to Treat Non-Hodgkin's Lymphoma in Patients With HIV Infection
- Official Title: Short-Course EPOCH - Rituximab in Untreated CD-20+ HIV-Associated Lymphomas
Clinical Trial IDs
- ORG STUDY ID:
010030
- SECONDARY ID:
01-C-0030
- NCT ID:
NCT00006436
- NCT ALIAS:
NCT00020384
Conditions
- Lymphoma, AIDS-related
- Lymphoma, Large B-Cell, Diffuse
Interventions
| Drug | Synonyms | Arms |
|---|
| Rituximab | | Arm 1 |
| filgrastim | | Arm 1 |
| EPOCH | | Arm 1 |
Purpose
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 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.
Detailed Description
Background:
This is a study to investigate in a preliminary fashion the feasibility of short course
chemotherapy to participants 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 participants 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:
Participants 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 conclusion of the study, we will estimate whether the number of cycles can be reduced
using the paradigm. If the cumulative number of participants to relapse exceeds 25 percent by
6 months, the study will be closed.
Following the completion of chemotherapy, restaging will be performed 2 months following the
end of treatment, then every 3 months for one year, every 6 months for one year, then every
12 months until relapse, death, or loss to follow up.
Antiretroviral therapy (ART) will be given concurrently with treatment regimen.
To study the effects of treatment approach on parameters of HIV disease, measurements of CD4
cells and viral loads will be made at baseline and at the completion of therapy, and then 2
months following the end of treatment, and then every 3-6 months for a total of 24 months
following chemotherapy.
Trial Arms
| Name | Type | Description | Interventions |
|---|
| Arm 1 | Experimental | Combination chemo and biological therapy | |
Eligibility Criteria
- INCLUSION CRITERIA:
Aggressive CD20 positive Diffuse Large B-cell lymphoma confirmed by Laboratory of
Pathology, NCI. Note: Participants with aggressive B-cell lymphoma of the plasmablastic
lymphoma sub-type who do not have surface CD20 expression, are also eligible.
HIV + serology.
All stages (I-IV) of disease.
ECOG Performance status 0-4
NHL previously untreated with cytotoxic chemotherapy; however, participants may be entered
if they have had prior cyclophosphamide for an urgent problem at diagnosis (e.g. epidural
cord compression, superior vena cava syndrome) and/or a single dose of intrathecal
methotrexte (MTX) at the time of the pre-treatment diagnostic lumbar puncture
Age greater than or equal to 18 years
Laboratory tests (unless impairment due to respective organ involvement by tumor):
- Creatinine less than or equal to 1.5 mg/dl or creatinine clearance greater than or
equal to 50 ml/min
- Bilirubin less than 2.0 mg/dl, or total bilirubin less than or equal to 4.5 mg/dl with
direct fraction less than or equal to 0.3 mg/dl in participants for whom these
abnormalities are felt to be due to protease inhibitor therapy
- AST and ALT less than or equal to 3x ULN (AST and ALT less than or equal to 6x ULN for
participants on hyperalimentation for whom these abnormalities are felt to be due to
the hyperalimentation)
- ANC greater than or equal to 1000/mm(3)
- Platelet greater than or equal to 75,000/mm(3) (unless impairment due to ITP)
Ability of participant to provide informed consent.
EXCLUSION CRITERIA:
Previous rituximab
Pregnancy or nursing.
- Doxorubicin, etoposide, vincristine and cyclophosphamide are teratogenic and may be
excreted in milk.
Current clinical heart failure or symptomatic ischemic heart disease.
Serious underlying medical condition or infection other than HIV that would contraindicate
SC-EPOCH-R.
- Examples include, but are not limited to:
- Severe AIDS-related wasting
- Sever intractable diarrhea
- Active inadequately treated opportunistic infection of the CNS
- Primary CNS lymphoma
Primary CNS lymphoma
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | Progression free survival |
| Time Frame: | Time of progressive disease |
| Safety Issue: | |
| Description: | Disease progression as indicated by imaging scans and blood tests (CD4 cells and viral loads) at baseline, at the completion of therapy, 2months following the end of treatment, and every 3-6 months (for a total of 24 months) following therapy. |
Secondary Outcome Measures
| Measure: | Overall response rate and duration |
| Time Frame: | Post treatment: every 2 months, then every 3 months, then every 6 months for 1 year then yearly |
| Safety Issue: | |
| Description: | number of patients who respond to treatment and the number of months they do not progress |
| Measure: | Safety and toxicity of SCEPOCH-R |
| Time Frame: | 6 Cycles |
| Safety Issue: | |
| Description: | number and types of AEs experienced |
Details
| Phase: | Phase 2 |
| Primary Purpose: | Interventional |
| Overall Status: | Active, not recruiting |
| Lead Sponsor: | National Cancer Institute (NCI) |
Trial Keywords
- AIDS
- Malignancy
- Antiretroviral
- Chemotherapy
- Monoclonal
Last Updated
July 20, 2021
