Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Combination Chemotherapy in Treating Patients With HIV-Related Non-Hodgkin's Lymphoma

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Closed 18 and over ITA-GICAT-C/941202-3 EU-96059, NCT00002905

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.

Entry Criteria

Disease Characteristics:

Histologically proven non-Hodgkin's lymphoma at first presentation
  No documented CNS involvement (i.e., primary CNS or meningeal lymphoma)

Positive serologic test for HIV antibodies required
  No opportunistic infection unless effectively treated

Disease relapsed, refractory, or unresponsive to first-line chemotherapy
  No more than 1 prior combination chemotherapy regimen
  Chemotherapy consisted of cyclophosphamide, doxorubicin, vincristine, and
     prednisone (CHOP) or a CHOP-like regimen, ACVBP, or other similar regimen

Prior/Concurrent Therapy:

See Disease Characteristics

Patient Characteristics:

Age:
  18 and over

Performance status:
  ECOG 0-3

Life expectancy:
  At least 1 month

Hematopoietic:
  Not specified

Hepatic:
  Bilirubin less than 5 times normal OR
  Transaminases less than 5 times normal

Renal:
  Creatinine less than 2 mg/dL

Expected Enrollment

15-20 patients will be treated on each regimen.

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.

Trial Contact Information

Trial Lead Organizations

Centro di Riferimento Oncologico - Aviano

Umberto Tirelli, MD, Protocol chair		Ph: 39-043-465-9284 Email: utirelli@cro.it

Registry Information
Official Title		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
Trial Start Date		1995-06-01
Registered in ClinicalTrials.gov		NCT00002905
Date Submitted to PDQ		1995-06-01
Information Last Verified		2000-12-01

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