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| Sponsored by: |
Centro di Riferimento Oncologico - Aviano |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00002905 |
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 | Intervention | Phase |
|---|---|---|
|
Lymphoma |
Drug: cyclophosphamide Drug: didanosine Drug: doxorubicin hydrochloride Drug: etoposide Drug: mitoxantrone hydrochloride Drug: prednimustine Drug: zidovudine |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment |
| 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 |
| Estimated Enrollment: | 20 |
| Study Start Date: | 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.
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 older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Italy | |
| Centro di Riferimento Oncologico - Aviano | |
| Aviano, Italy, 33081 | |
| Study Chair: | Umberto Tirelli, MD | Centro di Riferimento Oncologico - Aviano |
More Information
| Study ID Numbers: | CDR0000065256, ITA-GICAT-C/941202-3, EU-96059 |
| Study First Received: | November 1, 1999 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00002905 History of Changes |
| Health Authority: | United States: Federal Government |
|
AIDS-related peripheral/systemic lymphoma |
|
Antimetabolites Anti-Infective Agents Immunologic Factors Zidovudine Cyclophosphamide Etoposide phosphate Reverse Transcriptase Inhibitors Lymphoma, Small Cleaved-cell, Diffuse Anti-Bacterial Agents Anti-Retroviral Agents Prednimustine Analgesics Etoposide Lymphoma Alkylating Agents |
Anti-HIV Agents Immunoproliferative Disorders Acquired Immunodeficiency Syndrome Immunosuppressive Agents Antiviral Agents Doxorubicin Lymphatic Diseases Didanosine HIV Infections Peripheral Nervous System Agents Mitoxantrone Antineoplastic Agents, Alkylating Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Antirheumatic Agents |
|
Antimetabolites Anti-Infective Agents Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Zidovudine Cyclophosphamide Antibiotics, Antineoplastic Reverse Transcriptase Inhibitors Anti-Retroviral Agents Sensory System Agents Prednimustine Therapeutic Uses Analgesics |
Lymphoma Alkylating Agents Nucleic Acid Synthesis Inhibitors Anti-HIV Agents Immunoproliferative Disorders Neoplasms by Histologic Type Immune System Diseases Enzyme Inhibitors Antiviral Agents Immunosuppressive Agents Doxorubicin Pharmacologic Actions Lymphatic Diseases Neoplasms Didanosine |
