Phase I Trial of mBACOD and Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) in AIDS-Associated Large Cell, Immunoblastic, and Small Non-cleaved Lymphoma
Treatment of patients with AIDS-associated lymphoma is achieving inferior results when
compared with outcomes for non-AIDS patients. Treatment with mBACOD has been promising, but
the toxicity is very high. Patients treated with mBACOD have very low white blood cell
counts. GM-CSF has increased the number of white blood cells in animal studies and
preliminary human studies. It is hoped that including GM-CSF among the drugs given to
lymphoma patients will prevent or lessen the decrease in white blood cells caused by mBACOD.
Patients admitted to the study receive chemotherapy in 21-day cycles. The length of therapy,
2 - 8 months, depends on how the tumor responds to treatment. Four medicines are given on
day 1 of each cycle by vein (IV) (doxorubicin, cyclophosphamide, bleomycin, vincristine).
Dosages of doxorubicin and cyclophosphamide are increased in later groups of patients if
toxicity in the first group is tolerable. A fifth medicine (dexamethasone) is given by mouth
(PO) on days 1 - 5 of each cycle and the sixth medicine (methotrexate) is given IV on day 15
of each cycle. Leucovorin is given after methotrexate to prevent methotrexate side effects.
GM-CSF treatment is started on day 3 and continued for 11 days. To prevent the spread of the
tumor, a spinal tap is done on 4 occasions to inject cytosine arabinoside directly into the
spinal fluid. If tumor cells are present in the spinal fluid, the patient also takes
cytosine arabinoside by spinal tap 3 x/week until the tumor cells disappear and then at
monthly intervals for 1 year. Patients with tumor cells in the spinal fluid are also given
radiation treatment to the head.
Masking: Open Label, Primary Purpose: Treatment
United States: Federal Government
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