Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002740
Status:
COMPLETED
Last Update Posted:
2014-07-24
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy Plus Peripheral Stem Cell Transplantation Followed by Surgery andor Radiation Therapy in Treating Young Patients With Advanced Neuroblastoma
Sponsor:
Childrens Oncology Group
Organization:
Childrens Oncology Group
Study Overview
Official Title:
Phase I Pilot Study of Multiple Cycles of High Dose Chemotherapy With Peripheral Blood Stem Cell Infusions In Advanced Stage Neuroblastoma
Status:
COMPLETED
Status Verified Date:
2014-07
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 Peripheral stem cell transplantation may allow doctors to give higher doses of chemotherapy drugs and kill more tumor cells Radiation therapy uses high-energy x-rays to damage tumor cells
PURPOSE Phase I trial to study the effectiveness of combination chemotherapy plus peripheral stem cell transplantation followed by surgery andor radiation therapy in treating young patients who have newly diagnosed advanced neuroblastoma
PURPOSE Phase I trial to study the effectiveness of combination chemotherapy plus peripheral stem cell transplantation followed by surgery andor radiation therapy in treating young patients who have newly diagnosed advanced neuroblastoma
Detailed Description:
OBJECTIVES I Estimate the maximum tolerated dose of carboplatin that can be given in combination with cyclophosphamide CTX and etoposide following high dose CTX doxorubicin and vincristine in patients with newly diagnosed stage IV neuroblastoma II Determine the hematologic and nonhematologic toxic effects of this regimen in this patient population III Determine the change in neuroblastoma tumor cell content in peripheral blood stem cells PBSC collected following chemotherapy IV Assess the feasibility of repetitive collection storage and infusion of PBSC with multicycle high-dose chemotherapy in pediatric patients V Assess hematopoietic recovery following PBSC infusion as well as the CD34 content and CFU-GM yield of the PBSC products VI Assess the response rate and disease-free survival in the context of a phase I pilot study VII Determine the feasibility of administering twice-daily radiotherapy fractions to post-chemotherapy residual tumor volumes in neuroblastoma patients
OUTLINE This is a dose escalation study of carboplatin Patients receive induction chemotherapy consisting of vincristine IV over 24 hours cyclophosphamide IV over 4 hours and doxorubicin IV over 24 hours on days 0 1 21 and 22 Patients receive filgrastim G-CSF subcutaneously SQ or IV beginning on days 3 and 24 and continuing until blood counts recover Patients undergo peripheral blood stem cell PBSC collection after course 2 of induction chemotherapy Patients receive G-CSF SQ or IV for 2 days prior to and during collection PBSC are collected daily for 1-3 days Patients may undergo autologous bone marrow collection after course 1 of consolidation therapy after PBSC collection Following mobilization patients receive consolidation chemotherapy consisting of etoposide IV over 4 hours on days 0 1 and 2 and carboplatin IV over 1 hour and cyclophosphamide IV over 4 hours on days 0 and 1 Patients receive G-CSF SQ or IV beginning on day 3 within 4 hours of PBSC infusion and continuing until blood counts recover Patients receive PBSC reinfusion at 48-72 hours following completion of each chemotherapy course Treatment repeats every 3 weeks for 3 courses in the absence of disease progression or unacceptable toxicity Upon recovery from consolidation chemotherapy patients with no disease progression undergo tumor resection with or without radiotherapy Patients undergoing radiotherapy receive therapy twice daily over 7 days Patients with no disease progression less than 2 detectable bone marrow disease and adequate bone marrow cellularity may undergo additional therapy consisting of autologous bone marrow transplantation per appropriate transplant protocol Cohorts of 6-12 patients receive escalating doses of carboplatin until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 3 of 6 or 4 of 12 patients experience dose limiting toxicity Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 24-30 patients will be accrued for this study within approximately 2 years
OUTLINE This is a dose escalation study of carboplatin Patients receive induction chemotherapy consisting of vincristine IV over 24 hours cyclophosphamide IV over 4 hours and doxorubicin IV over 24 hours on days 0 1 21 and 22 Patients receive filgrastim G-CSF subcutaneously SQ or IV beginning on days 3 and 24 and continuing until blood counts recover Patients undergo peripheral blood stem cell PBSC collection after course 2 of induction chemotherapy Patients receive G-CSF SQ or IV for 2 days prior to and during collection PBSC are collected daily for 1-3 days Patients may undergo autologous bone marrow collection after course 1 of consolidation therapy after PBSC collection Following mobilization patients receive consolidation chemotherapy consisting of etoposide IV over 4 hours on days 0 1 and 2 and carboplatin IV over 1 hour and cyclophosphamide IV over 4 hours on days 0 and 1 Patients receive G-CSF SQ or IV beginning on day 3 within 4 hours of PBSC infusion and continuing until blood counts recover Patients receive PBSC reinfusion at 48-72 hours following completion of each chemotherapy course Treatment repeats every 3 weeks for 3 courses in the absence of disease progression or unacceptable toxicity Upon recovery from consolidation chemotherapy patients with no disease progression undergo tumor resection with or without radiotherapy Patients undergoing radiotherapy receive therapy twice daily over 7 days Patients with no disease progression less than 2 detectable bone marrow disease and adequate bone marrow cellularity may undergo additional therapy consisting of autologous bone marrow transplantation per appropriate transplant protocol Cohorts of 6-12 patients receive escalating doses of carboplatin until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 3 of 6 or 4 of 12 patients experience dose limiting toxicity Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 24-30 patients will be accrued for this study within approximately 2 years
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 |
|---|---|---|---|
| CCG-3951 | OTHER | None | None |
| CDR0000064656 | OTHER | Clinical Trialsgov | None |