Clinical Trial: Combination Chemotherapy in Treating Patients With AIDS-Related Lymphoma

This study is no longer recruiting patients.

Sponsors and Collaborators: National Cancer Institute (NCI)
Eastern Cooperative Oncology Group
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 consisting of liposomal doxorubicin, cyclophosphamide, vincristine, and prednisone in treating patients with AIDS -related lymphoma.

Condition Treatment or Intervention Phase
AIDS-related diffuse small cleaved cell lymphoma
AIDS-related small noncleaved cell lymphoma
AIDS-related lymphoblastic lymphoma
AIDS-related diffuse mixed cell lymphoma
AIDS-related immunoblastic large cell lymphoma
AIDS-related peripheral/systemic lymphoma
AIDS-related diffuse large cell lymphoma
anaplastic large cell lymphoma
 Procedure: chemotherapy
 Procedure: biological response modifier therapy
 Procedure: radiation therapy
 Procedure: colony-stimulating factor therapy
 Procedure: cytokine therapy
 Drug: cyclophosphamide
 Drug: cytarabine
 Drug: doxorubicin HCl liposome
 Drug: filgrastim
 Drug: methotrexate
 Drug: prednisone
 Drug: vincristine
Phase II

MedlinePlus related topics:  Cancer;   Cancer Alternative Therapy;   Lymphatic Diseases;   Lymphoma

Study Type: Interventional
Study Design: Treatment

Official Title: Phase II Study of Doxorubicin HCl Liposome, Cyclophosphamide, Vincristine, and Prednisone in Patients With AIDS-Related Systemic Lymphoma

Further Study Details: 

Study start: February 1999

OBJECTIVES: I. Determine the one year survival and complete response rate of patients treated with doxorubicin HCl liposome/cyclophosphamide/vincristine/prednisone (Doxil-CVP) for AIDS-related lymphoma. II. Evaluate the toxicity of a combination chemotherapy regimen, Doxil-CVP, in this patient population. III. Evaluate the progression free and overall survival after treatment with Doxil-CVP in this patient population. IV. Evaluate the effects of treatment with Doxil-CVP on plasma viral mRNA levels, CD4+ lymphocyte count, and the incidences and types of opportunistic infections in this patient population.

PROTOCOL OUTLINE: Patients are stratified according to disease characteristics. All patients receive a 30 minute infusion of doxorubicin HCl liposome IV, cyclophosphamide IV, and vincristine IV on day 1. Patients also receive oral prednisone on days 1-5. Filgrastim (G-CSF) is administered subcutaneously starting on day 6 and continues until the absolute neutrophil count is at least 10,000/mm3. Treatment courses are repeated every 21 days. Patients with lymphomatous bone marrow involvement and/or category J lymphoma receive cytarabine and methotrexate intrathecally weekly for 4 weeks. Patients with lymphomatous meningitis receive whole brain irradiation and an alternating intrathecal chemotherapy regimen. A minimum of 4 and a maximum of 8 courses are administered. Patients are removed from the study for progressive disease, stable disease after 4 courses, a life threatening infection that would delay treatment for more than 6 weeks, or any delay, except due to neutropenia, in chemotherapy treatment for more than 6 weeks. Patients who achieve a complete response receive an additional 2 courses of therapy. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and annually thereafter.

PROJECTED ACCRUAL: A total of 38 patients will be accrued for this study.

Eligibility

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

[A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology.]

--Prior/Concurrent Therapy--

--Patient Characteristics--

  • Age: 18 and over
  • Performance status: ECOG 0-2
  • Life expectancy: Not specified
  • Hematopoietic: (Except patients with lymphomatous marrow involvement) Absolute neutrophil count at least 1000/mm3; Platelet count at least 50,000/mm3
  • Hepatic: Bilirubin no greater than 5.0 mg/dL
  • Renal: Creatinine less than 3.0 mg/dL
  • Cardiovascular: Patients with history of heart disease, evidence of congestive heart failure, radiographic evidence of cardiomegaly, or electrocardiographic evidence of a prior myocardial infarction must have LVEF at least at lower limit of normal
  • Neurologic: No grade 3 or greater peripheral neuropathy
  • Other: No prior or concurrent malignancy other than Kaposi's sarcoma, curatively treated basal cell or squamous cell carcinoma of the skin, or curatively treated carcinoma in situ of the cervix; Not pregnant or nursing; Fertile patients must use effective contraception; No history of sensitivity to E. coli-derived proteins

Location Information


California
      Stanford University Medical Center, Stanford,  California,  94305-5408,  United States

      Veterans Affairs Medical Center - Palo Alto, Palo Alto,  California,  94304,  United States

New Jersey
      Raritan Bay Medical Center, Perth Amboy,  New Jersey,  08861,  United States

New York
      Albert Einstein Comprehensive Cancer Center, Bronx,  New York,  10461,  United States

      MBCCOP-Our Lady of Mercy Cancer Center, Bronx,  New York,  10466,  United States

Study chairs or principal investigators

Matthew D. Volm,  Study Chair,  Eastern Cooperative Oncology Group   

More Information

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

Study ID Numbers:  CDR0000066385; E-3D97
Record last reviewed:  December 2003
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003388
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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