Abstract
The use of full-dose intensive regimens of chemotherapy in patients with HIV-associated lymphoma has often resulted in severe toxicity, treatment delay, and reduced subsequent dosing. We conducted a Phase I trial to evaluate the toxicity of the combination of m-BACOD (methotrexate, Bleomycin, doxorubicin, cyclophosphamide, vincristine, dexamethasone) with granulocyte-macrophage colony stimulating factor (GMCSF) in these patients. A total of 17 patients were entered and treated at three dose levels of m-BACOD in combination with a fixed dose of GMCSF. Eight patients received standard dose m-BACOD plus GMCSF without experiencing dose-limiting hematologic toxicity, although significant nonhematologic toxicity was seen. We conclude that it is feasible to treat patients with HIV-associated lymphoma using standard dose m-BACOD plus GMCSF, but further study is needed to determine whether full-dose regimens improve survival when compared with reduced dose regimens in these individuals.
Publication types
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Clinical Trial
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Clinical Trial, Phase I
MeSH terms
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AIDS-Related Opportunistic Infections / complications
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Adult
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Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
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Bleomycin / administration & dosage
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Bleomycin / adverse effects
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Cyclophosphamide / administration & dosage
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Cyclophosphamide / adverse effects
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Dexamethasone / administration & dosage
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Dexamethasone / adverse effects
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Doxorubicin / administration & dosage
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Doxorubicin / adverse effects
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Granulocyte-Macrophage Colony-Stimulating Factor / adverse effects
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Granulocyte-Macrophage Colony-Stimulating Factor / therapeutic use*
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HIV Core Protein p24 / blood
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Humans
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Kidney / drug effects
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Leucovorin / administration & dosage
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Leucovorin / adverse effects
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Leukocyte Count / drug effects
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Lung / drug effects
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Lymphoma, AIDS-Related / blood
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Lymphoma, AIDS-Related / drug therapy*
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Lymphoma, Non-Hodgkin / blood
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Lymphoma, Non-Hodgkin / drug therapy*
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Male
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Methotrexate / administration & dosage
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Methotrexate / adverse effects
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Neutropenia / chemically induced
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Remission Induction
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Vincristine / administration & dosage
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Vincristine / adverse effects
Substances
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HIV Core Protein p24
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Bleomycin
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Vincristine
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Dexamethasone
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Doxorubicin
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Granulocyte-Macrophage Colony-Stimulating Factor
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Cyclophosphamide
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Leucovorin
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Methotrexate