Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002941
Status:
COMPLETED
Last Update Posted:
2014-08-01
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Children With Recurrent or Refractory Hodgkins or Non-Hodgkins Lymphoma
Sponsor:
Childrens Oncology Group
Organization:
Childrens Oncology Group
Study Overview
Official Title:
A Pilot Study of Peripheral Blood Stem Cell Transplantation PBSCT After Preparative Therapy Consisting of Cyclophosphamide BCNU and Etoposide CBV for Recurrent and Primarily Refractory Hodgkins and Non-Hodgkins Lymphoma
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 cancer cells from dividing so they stop growing or die Peripheral stem cell transplantation may allow doctors to give higher doses of chemotherapy and kill more cancer cells
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy followed by peripheral stem cell transplantation in treating children who have recurrent or refractory Hodgkins lymphoma or non-Hodgkins lymphoma
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy followed by peripheral stem cell transplantation in treating children who have recurrent or refractory Hodgkins lymphoma or non-Hodgkins lymphoma
Detailed Description:
OBJECTIVES
Estimate the failure-free survival rate in a cohort of relapsed Hodgkins lymphoma and non-Hodgkins lymphoma patients after retrieval therapy which includes peripheral blood stem cell transplantation PBSCT in patients who achieve a complete remission or partial remission
Estimate the post completepartial remission failure-free survival rate in these patients
Characterize the time to recovery of normal bone marrow function after transplantation in these patients
OUTLINE Patients receive 2 courses of reinduction chemotherapy followed by bone marrow biopsy and aspirate prior to peripheral blood stem cell PBSC harvest If marrow involvement is still present at harvest then 2 additional courses of induction chemotherapy are given
The PBSC transplantation preparative regimen should begin within 2 weeks of completing reinduction therapy course consisting of the following
Carmustine IV over 3 hours on days -8 -7 and -6
Etoposide continuous IV over days -8 -7 and -6
Cyclophosphamide IV over 1 hour daily on days -5 -4 -3 and -2
Mesna as a 15 min infusion before each dose of cyclophosphamide then at 3 6 9 and 12 hours after initiation of each cyclophosphamide dose Methylprednisolone IV is given to protect lungs from the toxic effects of carmustine
PROJECTED ACCRUAL A total of 30 patients will be accrued in each subgroup
Estimate the failure-free survival rate in a cohort of relapsed Hodgkins lymphoma and non-Hodgkins lymphoma patients after retrieval therapy which includes peripheral blood stem cell transplantation PBSCT in patients who achieve a complete remission or partial remission
Estimate the post completepartial remission failure-free survival rate in these patients
Characterize the time to recovery of normal bone marrow function after transplantation in these patients
OUTLINE Patients receive 2 courses of reinduction chemotherapy followed by bone marrow biopsy and aspirate prior to peripheral blood stem cell PBSC harvest If marrow involvement is still present at harvest then 2 additional courses of induction chemotherapy are given
The PBSC transplantation preparative regimen should begin within 2 weeks of completing reinduction therapy course consisting of the following
Carmustine IV over 3 hours on days -8 -7 and -6
Etoposide continuous IV over days -8 -7 and -6
Cyclophosphamide IV over 1 hour daily on days -5 -4 -3 and -2
Mesna as a 15 min infusion before each dose of cyclophosphamide then at 3 6 9 and 12 hours after initiation of each cyclophosphamide dose Methylprednisolone IV is given to protect lungs from the toxic effects of carmustine
PROJECTED ACCRUAL A total of 30 patients will be accrued in each subgroup
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 |
|---|---|---|---|
| CDR0000065390 | OTHER | Clinical Trialsgov | None |
| COG-A5962 | OTHER | None | None |
| CCG-A5962 | OTHER | None | None |
| POG-A5962 | OTHER | None | None |
| CCG-5962 | OTHER | None | None |