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

Primary Purpose

Lymphoma

Status
Unknown status
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
cyclophosphamide
didanosine
doxorubicin hydrochloride
etoposide
mitoxantrone hydrochloride
prednimustine
zidovudine
Sponsored by
Centro di Riferimento Oncologico - Aviano
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma focused on measuring AIDS-related peripheral/systemic lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 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 PRIOR CONCURRENT THERAPY: See Disease Characteristics

Sites / Locations

  • Centro di Riferimento Oncologico - Aviano

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
September 19, 2013
Sponsor
Centro di Riferimento Oncologico - Aviano
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1. Study Identification

Unique Protocol Identification Number
NCT00002905
Brief Title
Combination Chemotherapy in Treating Patients With HIV-Related Non-Hodgkin's Lymphoma
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2011
Overall Recruitment Status
Unknown status
Study Start Date
June 1995 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Centro di Riferimento Oncologico - Aviano

4. Oversight

5. Study Description

Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients with HIV-related non-Hodgkin's lymphoma that has relapsed or has not responded to chemotherapy.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma
Keywords
AIDS-related peripheral/systemic lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
cyclophosphamide
Intervention Type
Drug
Intervention Name(s)
didanosine
Intervention Type
Drug
Intervention Name(s)
doxorubicin hydrochloride
Intervention Type
Drug
Intervention Name(s)
etoposide
Intervention Type
Drug
Intervention Name(s)
mitoxantrone hydrochloride
Intervention Type
Drug
Intervention Name(s)
prednimustine
Intervention Type
Drug
Intervention Name(s)
zidovudine

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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 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 PRIOR CONCURRENT THERAPY: See Disease Characteristics
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Umberto Tirelli, MD
Organizational Affiliation
Centro di Riferimento Oncologico - Aviano
Official's Role
Study Chair
Facility Information:
Facility Name
Centro di Riferimento Oncologico - Aviano
City
Aviano
ZIP/Postal Code
33081
Country
Italy

12. IPD Sharing Statement

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

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