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 I trial to study the effectiveness of liposomal doxorubicin plus combination chemotherapy in treating patients who have AIDS -associated non-Hodgkin's lymphoma.

Condition	Treatment or Intervention	Phase
AIDS-related diffuse small cleaved cell lymphoma AIDS-related small noncleaved cell lymphoma AIDS-related diffuse mixed cell lymphoma AIDS-related immunoblastic large cell lymphoma AIDS-related diffuse large cell lymphoma AIDS-related lymphoblastic lymphoma	Drug: doxorubicin HCl liposome  Drug: methotrexate  Drug: prednisone  Drug: sargramostim  Drug: vincristine	Phase I

Further Study Details: 

OBJECTIVES: I. Determine the toxicity and maximum tolerated dose of doxorubicin HCl liposome when administered with combination chemotherapy in patients with AIDS-associated non-Hodgkin's lymphoma.

II. Determine the optimal phase II dose of doxorubicin HCl liposome to be administered with the combination chemotherapy regimen.

III. Determine the effect of this regimen on HIV viral load in these patients.

IV. Determine the clinical response to this regimen by these patients.

PROTOCOL OUTLINE: This is a dose escalation study of doxorubicin HCl liposome. Patients are stratified by risk group (good vs poor).

Patients receive doxorubicin HCl liposome IV, vincristine IV, and methotrexate intrathecally on day 1, followed by oral prednisone on days 1-5. Sargramostim (GM-CSF) is administered subcutaneously on days 5-14 until blood counts recover. Treatment repeats every 4 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of doxorubicin HCl liposome until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6 patients experience dose limiting toxicity.

Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.

PROJECTED ACCRUAL: A minimum of 42-48 patients will be accrued for this study.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Histologically proven good or poor prognosis AIDS-associated non-Hodgkin's lymphoma expressing CD20 antigen; HIV positive; Stage II-IV
• Good risk patients are defined as: Karnofsky 80-100%; No prior history of AIDS defining illness; No bone marrow involvement with lymphoma; No clinical, radiographic, or cytologic evidence of CNS lymphoma
• Bidimensionally measurable disease

--Prior/Concurrent Therapy--

• Biologic therapy: Not specified
• Chemotherapy: No prior doxorubicin or doxorubicin HCl liposome; No prior chemotherapy for non-Hodgkin's lymphoma, except single dose of intrathecal chemotherapy at time of staging lumbar puncture
• Endocrine therapy: Not specified
• Radiotherapy: Not specified
• Surgery: At least 2 weeks since major surgery
• Other: No concurrent treatment for Kaposi's sarcoma; Concurrent antiretroviral therapy allowed

--Patient Characteristics--

• Age: 18 and over
• Performance status: Karnofsky 80-100%
• Life expectancy: At least 3 months
• Hematopoietic: Absolute neutrophil count greater than 1,000/mm3; Platelet count greater than 75,000/mm3; Hemoglobin greater than 9 g/dL
• Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN); SGOT or SGPT less than 5 times ULN; Alkaline phosphatase less than 5 times ULN
• Renal: Creatinine no greater than 1.5 times ULN
• Other: Not pregnant; No active opportunistic or any other serious infection; No other malignancy (including any other AIDS-associated malignancy) except stable cutaneous Kaposi's sarcoma; No serious medical or psychiatric condition

Alabama
      University of Alabama Comprehensive Cancer Center, Birmingham,  Alabama,  35294,  United States

Study chairs or principal investigators

Mansoor Noorali Saleh,  Study Chair,  UAB Comprehensive Cancer Center   

Study ID Numbers:  CDR0000067402; UAB-9708; NCI-G99-1627; UAB-F970529007
Record last reviewed:  August 2004
Last Updated:  October 13, 2004
Record first received:  December 10, 1999
ClinicalTrials.gov Identifier:  NCT00004162
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08