Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002803
Status:
COMPLETED
Last Update Posted:
2013-12-19
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy or Observation Following Surgery in Treating Infants With Neuroblastoma
Sponsor:
Childrens Hospital Medical Center Cincinnati
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
COOPERATIVE MULTICENTER TRIAL FOR THE TREATMENT OF INFANTS WITH NEUROBLASTOMA
Status:
COMPLETED
Status Verified Date:
2008-04
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 Sometimes neuroblastoma will regress without treatment but sometimes additional treatment may be necessary Giving more than one chemotherapy drug after surgery to remove the tumor may kill more tumor cells
PURPOSE Phase II trial to study combination chemotherapy or observation following surgery in treating infants with neuroblastoma
PURPOSE Phase II trial to study combination chemotherapy or observation following surgery in treating infants with neuroblastoma
Detailed Description:
OBJECTIVES I Determine the incidence of spontaneous regression of localized neuroblastoma in infants II Determine how many infants with neuroblastoma do not need chemotherapy III Evaluate the time course of regression by radiologic criteria and catecholamine metabolites IV Determine the reliability of risk estimation by molecular characteristics N-myc amplification CD44 del 1p compared to clinical criteria V Evaluate whether reduced therapeutic toxicity results in a decrease in treatment-related deaths VI Correlate cytostatic drug levels with chemotherapy side effects
OUTLINE All patients undergo resection of the primary tumor and N-myc determination within 6 months of age unless critically ill then are treated according to risk Patients with amplified N-myc or with indeterminate N-myc amplification but with other risk features are treated per protocol GER-NB90 Stage 4S patients who are critically ill or thrombocytopenic receive doxorubicin vincristine and cyclophosphamide over 7 days Patients with no amplification of N-myc are observed for 6 months until between 12 and 18 months of age Patients with minimal residual disease less than 10 or diameter no greater than 2-5 mm continue observation while those with residual disease but no disease progression undergo repeat biopsy Patients whose biopsy indicates tumor regression also continue observation All other patients including those with disease progression are treated per protocol GER-NB90
PROJECTED ACCRUAL 36-44 patients per year will be accrued 22-27 patients with stages 1-3 8-10 patients with stage 4S and 6-7 patients with stage 4 neuroblastoma
OUTLINE All patients undergo resection of the primary tumor and N-myc determination within 6 months of age unless critically ill then are treated according to risk Patients with amplified N-myc or with indeterminate N-myc amplification but with other risk features are treated per protocol GER-NB90 Stage 4S patients who are critically ill or thrombocytopenic receive doxorubicin vincristine and cyclophosphamide over 7 days Patients with no amplification of N-myc are observed for 6 months until between 12 and 18 months of age Patients with minimal residual disease less than 10 or diameter no greater than 2-5 mm continue observation while those with residual disease but no disease progression undergo repeat biopsy Patients whose biopsy indicates tumor regression also continue observation All other patients including those with disease progression are treated per protocol GER-NB90
PROJECTED ACCRUAL 36-44 patients per year will be accrued 22-27 patients with stages 1-3 8-10 patients with stage 4S and 6-7 patients with stage 4 neuroblastoma
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 |
|---|---|---|---|
| GER-NB95-S | None | None | None |
| EU-96003 | None | None | None |