Immune System/AIDS |
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Clinical Trial: Combination Chemotherapy in Treating Patients With HIV-Related Non-Hodgkin's Lymphoma
This study is no longer recruiting patients.
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Purpose
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.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| AIDS-related peripheral/systemic lymphoma | Drug: cyclophosphamide Drug: didanosine Drug: doxorubicin Drug: etoposide Drug: mitoxantrone Drug: prednimustine Drug: zidovudine | Phase II |
MedlinePlus related topics: Lymphoma
Study Type: Interventional
Study Design: Treatment
Official Title: Phase II Study of Etoposide/Mitoxantrone/Prednimustine for Relapsed Disease and Cyclophosphamide/Doxorubicin/Etoposide for Refractory Disease in Patients with HIV-Associated non-Hodgkin's Lymphoma
Study start: June 1995
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.
PROTOCOL 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.
Eligibility
Ages Eligible for Study: 18 Years and above
Criteria
PROTOCOL 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
Location Information
Italy
Centro di Riferimento Oncologico - Aviano, Aviano, 33081, Italy
Umberto Tirelli, Study Chair, Centro di Riferimento Oncologico - Aviano
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Record last reviewed: June 2004
Last Updated: October 13, 2004
Record first received: November 1, 1999
ClinicalTrials.gov Identifier: NCT00002905
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 8, 2005

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