Phase I Trial of Liposomal Doxorubicin (Doxil) Based Combination Chemotherapy Regimen in AIDS-Associated Non-Hodgkin's Lymphoma
OBJECTIVES: I. Determine the toxicity and maximum tolerated dose of doxorubicin HCl liposome
when administered with combination chemotherapy in patients with AIDS-associated
non-Hodgkin's lymphoma. II. Determine the optimal phase II dose of doxorubicin HCl liposome
to be administered with the combination chemotherapy regimen. III. Determine the effect of
this regimen on HIV viral load in these patients. IV. Determine the clinical response to
this regimen by these patients.
OUTLINE: This is a dose escalation study of doxorubicin HCl liposome. Patients are
stratified by risk group (good vs poor). Patients receive doxorubicin HCl liposome IV,
vincristine IV, and methotrexate intrathecally on day 1, followed by oral prednisone on days
1-5. Sargramostim (GM-CSF) is administered subcutaneously on days 5-14 until blood counts
recover. Treatment repeats every 4 weeks for up to 6 courses in the absence of disease
progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of
doxorubicin HCl liposome until the maximum tolerated dose (MTD) is determined. The MTD is
defined as the dose at which 2 of 6 patients experience dose limiting toxicity. Patients are
followed every 3 months for 1 year, every 6 months for 2 years, and then annually
PROJECTED ACCRUAL: A minimum of 42-48 patients will be accrued for this study.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Determine the toxicity and maximum tolerated dose of doxorubicin HCl liposome when administered with combination chemotherapy in patients with AIDS-associated non-Hodgkin's lymphoma.
baseline to last dose of study drug
Mansoor N. Saleh, MD
University of Alabama at Birmingham
United States: Federal Government
|University of Alabama Comprehensive Cancer Center||Birmingham, Alabama 35294|