Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003019
Status:
COMPLETED
Last Update Posted:
2014-07-25
First Post:
2000-08-03
Brief Title:
Vinblastine and Methotrexate in Treating Children With Desmoid Tumors
Sponsor:
Childrens Oncology Group
Organization:
Childrens Oncology Group
Study Overview
Official Title:
Vinblastine and Methotrexate in Children With Desmoid Tumor Aggressive Fibromatosis Which is Recurrent or Not Amenable to Surgical Resection or Irradiation - A Pediatric Oncology Group Phase II Study
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 Combining more than one drug may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of chemotherapy with vinblastine and methotrexate in treating children who have desmoid tumors that are recurrent or untreatable with surgery or radiation therapy
PURPOSE Phase II trial to study the effectiveness of chemotherapy with vinblastine and methotrexate in treating children who have desmoid tumors that are recurrent or untreatable with surgery or radiation therapy
Detailed Description:
OBJECTIVES I Estimate the efficacy and toxicity of vinblastine and methotrexate for newly diagnosed or recurrent desmoid tumors in children who are not good candidates for treatment with surgery or radiation therapy
OUTLINE Patients receive vinblastine and methotrexate IV weekly for 26 weeks then every 2 weeks for an additional 26 weeks Treatment continues for a maximum of 1 year in the absence of unacceptable toxicity or disease progression Patients with a complete response receive an additional 8 doses of chemotherapy Patients are followed every 6 months for 4 years and then annually thereafter
PROJECTED ACCRUAL A total of 13-25 patients will be accrued for this study
OUTLINE Patients receive vinblastine and methotrexate IV weekly for 26 weeks then every 2 weeks for an additional 26 weeks Treatment continues for a maximum of 1 year in the absence of unacceptable toxicity or disease progression Patients with a complete response receive an additional 8 doses of chemotherapy Patients are followed every 6 months for 4 years and then annually thereafter
PROJECTED ACCRUAL A total of 13-25 patients will be accrued for this study
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-P9650 | OTHER | Childrens Oncology Group | None |
| POG-9650 | OTHER | None | None |
| CCG-P9650 | OTHER | None | None |
| CDR0000065601 | OTHER | None | None |