Overview
Combination Chemotherapy in Treating Patients With AIDS-Related Lymphoma
Status:
Completed
Completed
Trial end date:
1969-12-31
1969-12-31
Target enrollment:
0
0
Participant gender:
All
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 II trial to study the effectiveness of combination chemotherapy consisting of liposomal doxorubicin, cyclophosphamide, vincristine, and prednisone in treating patients with AIDS-related lymphoma.Phase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Eastern Cooperative Oncology GroupCollaborator:
National Cancer Institute (NCI)Treatments:
Cyclophosphamide
Cytarabine
Doxorubicin
Liposomal doxorubicin
Methotrexate
Prednisone
Vincristine
Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed AIDS-relatednon-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.
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
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