Ignite Creation Date:
2024-05-05 @ 11:32 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00070304
Status:
COMPLETED
Last Update Posted:
2013-07-26
First Post:
2003-10-03
Brief Title:
Gemcitabine and Vinorelbine in Treating Young Patients With Recurrent or Refractory Hodgkins Lymphoma
Sponsor:
Childrens Oncology Group
Organization:
Childrens Oncology Group
Study Overview
Official Title:
A Phase II Study Of Weekly Gemcitabine And Vinorelbine In Children With Recurrent Or Refractory 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 gemcitabine and vinorelbine use 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 This phase II trial is studying how well giving gemcitabine together with vinorelbine works in treating young patients with recurrent or refractory Hodgkins lymphoma
PURPOSE This phase II trial is studying how well giving gemcitabine together with vinorelbine works in treating young patients with recurrent or refractory Hodgkins lymphoma
Detailed Description:
OBJECTIVES
Determine the response rate of pediatric patients with recurrent or refractory Hodgkins lymphoma treated with gemcitabine and vinorelbine
Determine the toxicity of this regimen in these patients
OUTLINE This is a nonrandomized multicenter study
Patients receive vinorelbine IV over 6-10 minutes and gemcitabine IV over 100 minutes on days 1 and 8 Patients also receive filgrastim G-CSF subcutaneously daily beginning on day 9 and continuing for at least 7 days and until blood counts recover Treatment repeats every 21 days for at least 2 courses in the absence of disease progression or unacceptable toxicity Patients with responding disease after 2 courses may proceed directly to stem cell transplantation off study OR receive 2 additional courses Patients with stable disease after 2 courses receive at least 2 additional courses Patients with continued stable or responding disease with no disease progression after 4 courses may continue to receive study treatment for up to 1 year or discontinue study for alternative therapy at the discretion of the treating physician
Patients are followed for survival
PROJECTED ACCRUAL A total of 13-26 patients will be accrued for this study within 15 years
Determine the response rate of pediatric patients with recurrent or refractory Hodgkins lymphoma treated with gemcitabine and vinorelbine
Determine the toxicity of this regimen in these patients
OUTLINE This is a nonrandomized multicenter study
Patients receive vinorelbine IV over 6-10 minutes and gemcitabine IV over 100 minutes on days 1 and 8 Patients also receive filgrastim G-CSF subcutaneously daily beginning on day 9 and continuing for at least 7 days and until blood counts recover Treatment repeats every 21 days for at least 2 courses in the absence of disease progression or unacceptable toxicity Patients with responding disease after 2 courses may proceed directly to stem cell transplantation off study OR receive 2 additional courses Patients with stable disease after 2 courses receive at least 2 additional courses Patients with continued stable or responding disease with no disease progression after 4 courses may continue to receive study treatment for up to 1 year or discontinue study for alternative therapy at the discretion of the treating physician
Patients are followed for survival
PROJECTED ACCRUAL A total of 13-26 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 |
|---|---|---|---|
| COG-AHOD0321 | OTHER | Childrens Oncology Group | None |
| CDR0000331915 | OTHER | None | None |