Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006760
Status:
COMPLETED
Last Update Posted:
2013-07-26
First Post:
2000-12-06
Brief Title:
Combination Chemotherapy in Treating Children With Refractory or Relapsed Hodgkins Lymphoma
Sponsor:
Childrens Oncology Group
Organization:
Childrens Oncology Group
Study Overview
Official Title:
A Pilot Study of Re-Induction Chemotherapy With Ifosfamide and Vinorelbine IV in Children With RefractoryRelapsed Hodgkins Disease
Status:
COMPLETED
Status Verified Date:
2013-07
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 such as ifosfamide and vinorelbine work in different ways to stop cancer cells from dividing so they stop growing or die Combining more than one drug may kill more cancer cells
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy in treating children who have refractory or relapsed Hodgkins lymphoma
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy in treating children who have refractory or relapsed Hodgkins lymphoma
Detailed Description:
OBJECTIVES
Determine the response rate overall and within strata in both minimally pretreated low-risk and heavily pretreated high-risk children with refractory or relapsed Hodgkins lymphoma treated with ifosfamide and vinorelbine with filgrastim G-CSF
Determine the cardiac hepatic renal and hematologic toxicity of this regimen in minimally-pretreated low-risk patients
Determine the toxic death rate in minimally pretreated low-risk patients treated with this regimen
Determine whether this treatment regimen can mobilize sufficient hematopoietic stem cells CD34 for subsequent stem cell transplantation in minimally pretreated low-risk patients
Determine the incidence of hypermutability by longitudinal genotoxic biomonitoring of patients treated with this regimen
Determine the prognostic significance of biological markers including serum interleukin IL-10 receptor serum IL-2 receptor p53 and mdm-2 in patients treated with this regimen
OUTLINE This is a multicenter study Patients are stratified by prior therapy minimally pretreated low-risk vs heavily pretreated high-risk
Patients receive ifosfamide IV over 24 hours on days 1-4 and vinorelbine IV over 6-10 minutes on days 1 and 5 Patients also receive filgrastim G-CSF subcutaneously or IV over 15-30 minutes beginning 24-36 hours after completion of vinorelbine and continuing daily until blood counts recover Treatment repeats at least every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity Patients may receive a third course of therapy at the discretion of the investigator
Heavily pretreated high-risk patients who achieve a complete response are eligible for stem cell transplantation Patients undergo peripheral blood stem cell PBSC collection during hematopoietic recovery after the second course of chemotherapy Patients with sufficient PBSCs collected may undergo PBSC transplantation on protocol COG-AHOD0121
Patients are followed at 1 6 and 12 months and then periodically thereafter
PROJECTED ACCRUAL A total of 66 patients will be accrued for this study within 15 years
Determine the response rate overall and within strata in both minimally pretreated low-risk and heavily pretreated high-risk children with refractory or relapsed Hodgkins lymphoma treated with ifosfamide and vinorelbine with filgrastim G-CSF
Determine the cardiac hepatic renal and hematologic toxicity of this regimen in minimally-pretreated low-risk patients
Determine the toxic death rate in minimally pretreated low-risk patients treated with this regimen
Determine whether this treatment regimen can mobilize sufficient hematopoietic stem cells CD34 for subsequent stem cell transplantation in minimally pretreated low-risk patients
Determine the incidence of hypermutability by longitudinal genotoxic biomonitoring of patients treated with this regimen
Determine the prognostic significance of biological markers including serum interleukin IL-10 receptor serum IL-2 receptor p53 and mdm-2 in patients treated with this regimen
OUTLINE This is a multicenter study Patients are stratified by prior therapy minimally pretreated low-risk vs heavily pretreated high-risk
Patients receive ifosfamide IV over 24 hours on days 1-4 and vinorelbine IV over 6-10 minutes on days 1 and 5 Patients also receive filgrastim G-CSF subcutaneously or IV over 15-30 minutes beginning 24-36 hours after completion of vinorelbine and continuing daily until blood counts recover Treatment repeats at least every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity Patients may receive a third course of therapy at the discretion of the investigator
Heavily pretreated high-risk patients who achieve a complete response are eligible for stem cell transplantation Patients undergo peripheral blood stem cell PBSC collection during hematopoietic recovery after the second course of chemotherapy Patients with sufficient PBSCs collected may undergo PBSC transplantation on protocol COG-AHOD0121
Patients are followed at 1 6 and 12 months and then periodically thereafter
PROJECTED ACCRUAL A total of 66 patients will be accrued for this study within 15 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-A5981 | OTHER | None | None |
| CDR0000068325 | OTHER | None | None |
| NCI-2012-02366 | OTHER | None | None |
| U10CA098543 | NIH | NCI | httpsreporternihgovquickSearchU10CA098543 |