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

Further Study Details: 

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.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Histologically or cytologically confirmed AIDS-related non-Hodgkin's lymphoma of the intermediate or high grade histologic types; Anaplastic large cell lymphoma allowed
• Must be HIV positive
• Must have at least one objective measurable or evaluable disease parameter
• No parenchymal CNS involvement by lymphoma (meningeal lymphoma allowed)

[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--

• Biologic therapy: At least 5 days since interferon therapy
• Chemotherapy: No prior cytotoxic chemotherapy except for mucocutaneous Kaposi's sarcoma; At least 12 months since cytotoxic chemotherapy for Kaposi's sarcoma
• Endocrine therapy: Prior steroids allowed; No concurrent steroid therapy greater than 5 mg prednisone (or equivalent) per day
• Radiotherapy: No prior radiotherapy except for mucocutaneous Kaposi's sarcoma
• Surgery: Not specified
• Other: No concurrent zidovudine (AZT); Concurrent antiretroviral medications other than AZT allowed

--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

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   

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