Combination Chemotherapy in Treating Patients With HIV-Related Non-Hodgkin's Lymphoma
|ClinicalTrials.gov Identifier: NCT00002905|
Recruitment Status : Unknown
Verified September 2011 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : June 9, 2004
Last Update Posted : September 20, 2013
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 or disease||Intervention/treatment||Phase|
|Lymphoma||Drug: cyclophosphamide Drug: didanosine Drug: doxorubicin hydrochloride Drug: etoposide Drug: mitoxantrone hydrochloride Drug: prednimustine Drug: zidovudine||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|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 Start Date :||June 1995|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002905
|Centro di Riferimento Oncologico - Aviano|
|Aviano, Italy, 33081|
|Study Chair:||Umberto Tirelli, MD||Centro di Riferimento Oncologico - Aviano|