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Chemotherapy in Treating Children With Neuroblastoma

Primary Purpose

Neuroblastoma

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
buthionine sulfoximine
melphalan
Sponsored by
Children's Hospital Los Angeles
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neuroblastoma focused on measuring recurrent neuroblastoma

Eligibility Criteria

undefined - 21 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Children's Hospital Los Angeles
  • UCSF Cancer Center and Cancer Research Institute
  • University of Minnesota Cancer Center
  • Children's Hospital of Philadelphia

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
January 30, 2017
Sponsor
Children's Hospital Los Angeles
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00002730
Brief Title
Chemotherapy in Treating Children With Neuroblastoma
Official Title
PILOT STUDY OF BUTHIONINE SULFOXIMINE (BSO) IN COMBINATION WITH MELPHALAN FOR HIGH RISK NEUROBLASTOMA PATIENTS
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
June 1996 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Children's Hospital Los Angeles
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Some tumors become resistant to chemotherapy drugs. Combining buthionine sulfoximine with chemotherapy may reduce resistance to the drug and allow more tumor cells to be killed. PURPOSE: Phase I trial to study the effectiveness of melphalan, buthionine sulfoximine, and G-CSF in treating children with progressive neuroblastoma that has not responded to previous therapy.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuroblastoma
Keywords
recurrent neuroblastoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
buthionine sulfoximine
Intervention Type
Drug
Intervention Name(s)
melphalan

10. Eligibility

Sex
All
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
C. Patrick Reynolds, MD, PhD
Organizational Affiliation
Children's Hospital Los Angeles
Official's Role
Study Chair
Facility Information:
Facility Name
Children's Hospital Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027-0700
Country
United States
Facility Name
UCSF Cancer Center and Cancer Research Institute
City
San Francisco
State/Province
California
ZIP/Postal Code
94115-0128
Country
United States
Facility Name
University of Minnesota Cancer Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

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Chemotherapy in Treating Children With Neuroblastoma

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