PILOT STUDY OF BUTHIONINE SULFOXIMINE (BSO) IN COMBINATION WITH MELPHALAN FOR HIGH RISK NEUROBLASTOMA PATIENTS
OBJECTIVES: I. Describe the toxic effects of combined chemotherapy with buthionine
sulfoximine (BSO) and melphalan (L-PAM) in pediatric patients with progressive
neuroblastoma. II. Determine the pharmacokinetics of BSO/L-PAM in pediatric patients. III.
Assess the ability of BSO to deplete glutathione by at least 90% in tumor metastatic to bone
marrow, in normal marrow, and in peripheral blood lymphocytes. IV. Estimate the response
rate in these patients treated with BSO/L-PAM within the confines of a pilot study.
OUTLINE: The following acronyms are used: BSO Buthionine sulfoximine, NSC-326231 L-PAM
Melphalan, NSC-8806 G-CSF Granulocyte Colony-Stimulating Factor, NSC-614629 Single-Agent
Chemotherapy with Drug Resistance Inhibition. L-PAM/BSO.
PROJECTED ACCRUAL: At least 18 patients will be entered to provide an adequate number of
patients with marrow involvement; if the BSO dose is increased to achieve adequate GSH
depletion in the marrow, an additional 12 patients will be entered. If less than 50% of
patients have tumor metastatic to marrow at entry, there will be a proportional increase in
the total number of patients required.
Primary Purpose: Treatment
C. Patrick Reynolds, MD, PhD
Children's Hospital Los Angeles
United States: Federal Government
|Children's Hospital of Philadelphia||Philadelphia, Pennsylvania 19104|
|University of Minnesota Cancer Center||Minneapolis, Minnesota 55455|
|UCSF Cancer Center and Cancer Research Institute||San Francisco, California 94115-0128|
|Children's Hospital Los Angeles||Los Angeles, California 90027-0700|