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


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Water-Related Injuries




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

This study is no longer recruiting patients.

Sponsored by: Centro di Riferimento Oncologico - Aviano
Information provided by: National Cancer Institute (NCI)

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

Further Study Details: 

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--

--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

Study chairs or principal investigators

Umberto Tirelli,  Study Chair,  Centro di Riferimento Oncologico - Aviano   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000065256; ITA-GICAT-C/941202-3; EU-96059
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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December 1, 2008



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