Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002730
Status:
COMPLETED
Last Update Posted:
2017-02-01
First Post:
1999-11-01
Brief Title:
Chemotherapy in Treating Children With Neuroblastoma
Sponsor:
Childrens Hospital Los Angeles
Organization:
Childrens Hospital Los Angeles
Study Overview
Official Title:
PILOT STUDY OF BUTHIONINE SULFOXIMINE BSO IN COMBINATION WITH MELPHALAN FOR HIGH RISK NEUROBLASTOMA PATIENTS
Status:
COMPLETED
Status Verified Date:
2017-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 BSOL-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 BSOL-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-PAMBSO
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
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-PAMBSO
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-T95-0092O | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000064620 | REGISTRY | None | None |