A Phase III Randomized Trial of Low-Dose Versus Standard-Dose mBACOD Chemotherapy With rGM-CSF for Treatment of AIDS-Associated Non-Hodgkin's Lymphoma
HIV-infected patients are at increased risk for developing intermediate and high-grade NHL.
While combination chemotherapy for aggressive B-cell NHL in the absence of immunodeficiency
is highly effective, the outcome of therapy for patients with AIDS-associated NHL has been
disappointing. Treatment is frequently complicated by the occurrence of multiple
opportunistic infections, as well as the presence of poor bone marrow reserve, making the
administration of standard doses of chemotherapy difficult. A recent study was completed
using a low-dose modification of the standard mBACOD (cyclophosphamide, doxorubicin,
vincristine, bleomycin, dexamethasone, methotrexate ) treatment. A 46 percent response rate
was observed in patients treated with this combination of chemotherapeutic agents, with a
number of durable remissions and reduced toxicity when compared to previous experience with
more standard treatments. A subsequent study showed similar effectiveness using a lower dose
of methotrexate administered on day 15. It is hoped that the use of sargramostim
(granulocyte-macrophage colony-stimulating factor; GM-CSF) will improve bone marrow function
and allow for administration of a higher dose of chemotherapy.
Patients are randomized to one of two treatment groups. Patients are stratified for (1)
presence or absence of a prior AIDS diagnosis, (2) Karnofsky performance status of 70 or
greater and lower than 70. Treatment includes prophylaxis for meningeal lymphoma and
Pneumocystis carinii pneumonia. Patients on low-dose mBACOD who experience neutropenia may
be given rGM-CSF until the absolute neutrophil count improves. AZT may be initiated at the
completion of chemotherapy for all patients in complete remission at that time.
PER AMENDMENT 5/30/95: This trial was closed to accrual on 11/7/94 on the recommendation of
the Data and Safety Monitoring Board (DSMB), because the non-significant difference in
survival between the 2 treatment groups was not expected to change with further enrollment.
Interventional
Masking: Open Label, Primary Purpose: Treatment
L Kaplan
Study Chair
United States: Federal Government
ACTG 142
NCT00000658
February 1996
Name | Location |
---|---|
UCLA CARE Center CRS | Los Angeles, California 90095 |
USC CRS | Los Angeles, California 90033 |
Ucsf Aids Crs | San Francisco, California |
University of Colorado Hospital CRS | Aurora, Colorado 80262 |
Northwestern University CRS | Chicago, Illinois 60611 |
Rush Univ. Med. Ctr. ACTG CRS | Chicago, Illinois 60612 |
Indiana Univ. School of Medicine, Infectious Disease Research Clinic | Indianapolis, Indiana 46202 |
Johns Hopkins Adult AIDS CRS | Baltimore, Maryland 21287 |
Beth Israel Deaconess - East Campus A0102 CRS | Boston, Massachusetts 02215 |
Beth Israel Deaconess Med. Ctr., ACTG CRS | Boston, Massachusetts 02215 |
Bmc Actg Crs | Boston, Massachusetts 02118 |
Washington U CRS | St. Louis, Missouri |
SUNY - Buffalo, Erie County Medical Ctr. | Buffalo, New York 14215 |
NY Univ. HIV/AIDS CRS | New York, New York 10016 |
Memorial Sloan-Kettering Cancer Ctr. | New York, New York 10021 |
Beth Israel Med. Ctr. (Mt. Sinai) | New York, New York 10003 |
Univ. of Rochester ACTG CRS | Rochester, New York 14642 |
Unc Aids Crs | Chapel Hill, North Carolina 27599 |
Case CRS | Cleveland, Ohio 44106 |
The Ohio State Univ. AIDS CRS | Columbus, Ohio 43210 |
Hosp. of the Univ. of Pennsylvania CRS | Philadelphia, Pennsylvania 19104 |
Pitt CRS | Pittsburgh, Pennsylvania 15213 |