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

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

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.

Study Overview

• Status: Unknown
• Conditions: Lymphoma
• Intervention / Treatment: Drug: cyclophosphamide; Drug: mitoxantrone hydrochloride; Drug: etoposide; Drug: doxorubicin hydrochloride; Drug: didanosine; Drug: prednimustine; Drug: zidovudine

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.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 2

Contacts and Locations

Study Locations

• Italy
  • Aviano, Italy, 33081
    • Centro di Riferimento Oncologico - Aviano

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment

Collaborators and Investigators

• Sponsor: Centro di Riferimento Oncologico - Aviano
• Investigators: Study Chair: Umberto Tirelli, MD, Centro di Riferimento Oncologico - Aviano

Study record dates

Study Major Dates

• Study Start: June 1, 1995

Study Registration Dates

• First Submitted: November 1, 1999
• First Submitted That Met QC Criteria: June 8, 2004
• First Posted (Estimate): June 9, 2004

Study Record Updates

• Last Update Posted (Estimate): September 20, 2013
• Last Update Submitted That Met QC Criteria: September 19, 2013
• Last Verified: September 1, 2011

More Information

Terms related to this study

• Keywords: AIDS-related peripheral/systemic lymphoma
• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma; Lymphoma, Non-Hodgkin; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Peripheral Nervous System Agents; Antiviral Agents; Reverse Transcriptase Inhibitors; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; Analgesics; Sensory System Agents; Antirheumatic Agents; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Antineoplastic Agents, Alkylating; Alkylating Agents; Myeloablative Agonists; Antineoplastic Agents, Phytogenic; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Antibiotics, Antineoplastic; Cyclophosphamide; Etoposide; Zidovudine; Doxorubicin; Liposomal doxorubicin; Mitoxantrone; Didanosine; Prednimustine
• Other Study ID Numbers: CDR0000065256; ITA-GICAT-C-941202-3; EU-96059