Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003234
Status:
COMPLETED
Last Update Posted:
2014-07-28
First Post:
1999-11-01
Brief Title:
Vinorelbine in Treating Children With Recurrent or Refractory Cancers
Sponsor:
Childrens Oncology Group
Organization:
Childrens Oncology Group
Study Overview
Official Title:
A Phase II Study of Navelbine Vinorelbine In Children With Recurrent Or Refractory Malignancies
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
PURPOSE Phase II trial to study the effectiveness of vinorelbine in treating children with recurrent or refractory cancer
PURPOSE Phase II trial to study the effectiveness of vinorelbine in treating children with recurrent or refractory cancer
Detailed Description:
OBJECTIVES I Determine the response rate of children with recurrent or refractory malignancies treated with vinorelbine II Assess the toxic effects of this drug in these children
OUTLINE Patients receive vinorelbine IV over 6-10 minutes weekly on weeks 1-6 Treatment repeats every 8 weeks for a total of 10 courses in the absence of disease progression or unacceptable toxicity Patients are followed every 4 months for 2 years every 6 months for 1 year and then annually thereafter
PROJECTED ACCRUAL A maximum of 100 patients will be accrued for this study within 2 years
OUTLINE Patients receive vinorelbine IV over 6-10 minutes weekly on weeks 1-6 Treatment repeats every 8 weeks for a total of 10 courses in the absence of disease progression or unacceptable toxicity Patients are followed every 4 months for 2 years every 6 months for 1 year and then annually thereafter
PROJECTED ACCRUAL A maximum of 100 patients will be accrued for this study within 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 |
|---|---|---|---|
| CDR0000066106 | OTHER | Clinical Trialsgov | None |
| COG-A09705 | OTHER | None | None |
| CCG-09705 | OTHER | None | None |