Phase I trial of m-BACOD and granulocyte macrophage colony stimulating factor in HIV-associated non-Hodgkin's lymphoma

J Acquir Immune Defic Syndr (1988). 1993 Mar;6(3):265-71.

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

  • Clinical Trial
  • Clinical Trial, Phase I

MeSH terms

  • AIDS-Related Opportunistic Infections / complications
  • Adult
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
  • Bleomycin / administration & dosage
  • Bleomycin / adverse effects
  • Cyclophosphamide / administration & dosage
  • Cyclophosphamide / adverse effects
  • Dexamethasone / administration & dosage
  • Dexamethasone / adverse effects
  • Doxorubicin / administration & dosage
  • Doxorubicin / adverse effects
  • Granulocyte-Macrophage Colony-Stimulating Factor / adverse effects
  • Granulocyte-Macrophage Colony-Stimulating Factor / therapeutic use*
  • HIV Core Protein p24 / blood
  • Humans
  • Kidney / drug effects
  • Leucovorin / administration & dosage
  • Leucovorin / adverse effects
  • Leukocyte Count / drug effects
  • Lung / drug effects
  • Lymphoma, AIDS-Related / blood
  • Lymphoma, AIDS-Related / drug therapy*
  • Lymphoma, Non-Hodgkin / blood
  • Lymphoma, Non-Hodgkin / drug therapy*
  • Male
  • Methotrexate / administration & dosage
  • Methotrexate / adverse effects
  • Neutropenia / chemically induced
  • Remission Induction
  • Vincristine / administration & dosage
  • Vincristine / adverse effects

Substances

  • HIV Core Protein p24
  • Bleomycin
  • Vincristine
  • Dexamethasone
  • Doxorubicin
  • Granulocyte-Macrophage Colony-Stimulating Factor
  • Cyclophosphamide
  • Leucovorin
  • Methotrexate

Supplementary concepts

  • M-BACOD protocol