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PILOT STUDY OF BUTHIONINE SULFOXIMINE (BSO) IN COMBINATION WITH MELPHALAN FOR HIGH RISK NEUROBLASTOMA PATIENTS


Phase 1
N/A
21 Years
Not Enrolling
Both
Neuroblastoma

Thank you

Trial Information

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.

Inclusion Criteria


DISEASE CHARACTERISTICS: Neuroblastoma histologically confirmed at initial diagnosis or
demonstration of malignant, small, round cell tumor with elevated catecholamine
metabolites Refractory to conventional therapy and other higher priority therapy

PATIENT CHARACTERISTICS: Age: No greater than 21 at diagnosis Performance status: 0-2 Life
expectancy: At least 2 months Hematopoietic: Cytopenias from marrow involvement eligible
with study chairman approval ANC at least 1,000 Platelets at least 100,000 (transfusion
independent) Counts between 70,000-100,000 allowed provided: Autologous bone marrow or
peripheral stem cells available for rescue Study chairman approves entry Hemoglobin at
least 8 g/dL (may transfuse) Hepatic: Bilirubin no greater than 1.5 times normal AST/ALT
less than 2.5 times normal Renal: Creatinine no greater than 1.5 times normal OR
Creatinine clearance or radioisotope GFR at least 70 mL/min per 1.73 square meters
Pulmonary: No history of dyspnea at rest No exercise intolerance Other: No active
infection requiring hospitalization No pregnant or nursing women Negative pregnancy test
required of fertile women Effective contraception required of fertile patients during and
for 2 months after study Patients unable to receive blood products due to religious
reasons may receive buthionine sulfoximine alone

PRIOR CONCURRENT THERAPY: At least 6 months since myeloablative therapy with bone marrow
transplantation Recovered from toxic effects of prior therapy Biologic therapy: Not
specified Chemotherapy: At least 3 weeks since chemotherapy (6 weeks since mitomycin or
nitrosourea) Endocrine therapy: Not specified Radiotherapy: At least 6 weeks since
radiotherapy to any extremity site or significant marrow-containing compartment At least 6
months since the following: More than 24 Gy craniospinal irradiation Total abdominopelvic
plus lung irradiation Mantle plus Y-port irradiation Total-body irradiation No palliative
radiotherapy to bony lesions within 1 month after entry Surgery: Not specified

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

C. Patrick Reynolds, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Children's Hospital Los Angeles

Authority:

United States: Federal Government

Study ID:

CDR0000064620

NCT ID:

NCT00002730

Start Date:

June 1996

Completion Date:

Related Keywords:

  • Neuroblastoma
  • recurrent neuroblastoma
  • Neuroblastoma

Name

Location

Children's Hospital of PhiladelphiaPhiladelphia, Pennsylvania  19104
University of Minnesota Cancer CenterMinneapolis, Minnesota  55455
UCSF Cancer Center and Cancer Research InstituteSan Francisco, California  94115-0128
Children's Hospital Los AngelesLos Angeles, California  90027-0700