Trial Information

Short-Course EPOCH-Rituximab for Untreated CD-20+ HIV-Associated Lymphomas

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.

Objectives:

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.

Assess toxicity of SC-EPOCH-R.

Assess response rate and duration of SC-EPOCH-R.

Assess the utility of PET scans to predict freedom from relapse with SC-EPOCH-R.

Assess effects SC-EPOCH-R on CD4 cell depletion and recovery.

Assess response to antiretroviral therapy following SC-EPOCH-R.

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 4 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 conclusion of the study, we will estimate whether the number of cycles can be reduced
using the paradigm. If the cumulative number of patients 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.

Anti-HIV therapy will be suspended prior to initiation of the chemotherapy and optimum
therapy will be reinitiated after all the cycles have been administered.

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.