PROSPECTIVE NON-RANDOMIZED STUDY WITH CHEMOTHERAPY FOR RELAPSED OR REFRACTORY HIV-RELATED NON-HODGKIN'S LYMPHOMA: VMP REGIMEN FOR RELAPSED PATIENTS, CDE REGIMEN FOR REFRACTORY PATIENTS
OBJECTIVES: I. Evaluate the response rate and duration of response to etoposide,
mitoxantrone, and prednimustine in patients with relapsed HIV-associated non-Hodgkin's
lymphoma (NHL). II. Evaluate the response rate and duration of response to cyclophosphamide,
doxorubicin, and etoposide in patients with refractory HIV-associated NHL. III. Assess the
toxic effects of these regimens in these patients.
OUTLINE: Patients with relapsed non-Hodgkin's lymphoma (NHL) receive oral etoposide and
prednimustine on days 1-5 and intravenous mitoxantrone on day 1 every 3 weeks. Patients with
refractory NHL receive cyclophosphamide, doxorubicin, and etoposide as a continuous infusion
over 4 days every 4 weeks. All patients receive concomitant antiretroviral therapy with
zidovudine or didanosine. G-CSF is given for hematologic support as indicated. All patients
are evaluated for response after 2 courses of chemotherapy. Patients with a complete
response (CR) receive 2 additional courses. Patients with a stable or partial response
receive 2 additional courses and are re-evaluated; those with a CR receive 2 more courses,
while those with a stable or partial response are treated off study at the physician's
discretion. Patients with progressive disease are removed from study.
PROJECTED ACCRUAL: 15-20 patients will be treated on each regimen.
Interventional
Primary Purpose: Treatment
Umberto Tirelli, MD
Study Chair
Centro di Riferimento Oncologico - Aviano
United States: Federal Government
CDR0000065256
NCT00002905
June 1995
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