Overview

Liposomal Doxorubicin Plus Combination Chemotherapy in Treating Patients With AIDS-Associated Non-Hodgkin's Lymphoma

Status:
Completed
Trial end date:
2001-01-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Alabama at Birmingham
Collaborator:
National Cancer Institute (NCI)
Treatments:
Doxorubicin
Liposomal doxorubicin
Methotrexate
Sargramostim
Vincristine
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

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

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