Phase I trial of m-BACOD and granulocyte macrophage colony stimulating factor in HIV-associated non-Hodgkin's lymphoma.
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.
Walsh
C
C
New York University School of Medicine, New York.
Wernz
J C
JC
Levine
A
A
Rarick
M
M
Willson
E
E
Melendez
D
D
Bonnem
E
E
Thompson
J
J
Shelton
B
B
D017088:AIDS-Related Opportunistic Infections / Q000150:complications; D000328:Adult; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001761:Bleomycin / Q000008:administration & dosage / Q000009:adverse effects; D003520:Cyclophosphamide / Q000008:administration & dosage / Q000009:adverse effects; D003907:Dexamethasone / Q000008:administration & dosage / Q000009:adverse effects; D004317:Doxorubicin / Q000008:administration & dosage / Q000009:adverse effects; D016178:Granulocyte-Macrophage Colony-Stimulating Factor / Q000009:adverse effects / Q000627:therapeutic use*; D016655:HIV Core Protein p24 / Q000097:blood; D006801:Humans; D007668:Kidney / Q000187:drug effects; D002955:Leucovorin / Q000008:administration & dosage / Q000009:adverse effects; D007958:Leukocyte Count / Q000187:drug effects; D008168:Lung / Q000187:drug effects; D016483:Lymphoma, AIDS-Related / Q000097:blood / Q000188:drug therapy*; D008228:Lymphoma, Non-Hodgkin / Q000097:blood / Q000188:drug therapy*; D008297:Male; D008727:Methotrexate / Q000008:administration & dosage / Q000009:adverse effects; D009503:Neutropenia / Q000139:chemically induced; D012074:Remission Induction; D014750:Vincristine / Q000008:administration & dosage / Q000009:adverse effects
D016655:HIV Core Protein p24; D001761:Bleomycin; D014750:Vincristine; D003907:Dexamethasone; D004317:Doxorubicin; D016178:Granulocyte-Macrophage Colony-Stimulating Factor; D003520:Cyclophosphamide; D002955:Leucovorin; D008727:Methotrexate