Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00030264
Status:
COMPLETED
Last Update Posted:
2018-08-08
First Post:
2002-02-14
Brief Title:
Combination Chemotherapy in Treating Patients With Neurofibromatosis and Progressive Plexiform Neurofibromas
Sponsor:
Childrens Hospital of Philadelphia
Organization:
Childrens Hospital of Philadelphia
Study Overview
Official Title:
VinblastineMethotrexate For Severe Progressive Plexiform Neurofibromas A Phase II Study
Status:
COMPLETED
Status Verified Date:
2018-07
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 methotrexate with vinblastine may be effective treatment for neurofibromatosis type 1 associated with progressive plexiform neurofibromas
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have neurofibromatosis type 1 associated with progressive plexiform neurofibromas
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have neurofibromatosis type 1 associated with progressive plexiform neurofibromas
Detailed Description:
OBJECTIVES
Determine the effect of chronic vinblastine and methotrexate on time to disease progression in children or young adults with progressive plexiform neurofibroma associated with neurofibromatosis type 1
Determine the objective response rate in patients treated with this regimen
Determine the toxic effects of this regimen in these patients
Determine the quality of life of patients treated with this regimen
OUTLINE Patients are stratified according to tumor status severely debilitating andor life-threatening vs cosmetically disfiguring
Patients receive methotrexate and vinblastine IV weekly for 26 weeks and then every 2 weeks for 26 weeks in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at baseline and then every 3 months during study participation
Patients are followed every 3 months until disease progression
PROJECTED ACCRUAL A total of 35 patients will be accrued for this study within approximately 3 years
Determine the effect of chronic vinblastine and methotrexate on time to disease progression in children or young adults with progressive plexiform neurofibroma associated with neurofibromatosis type 1
Determine the objective response rate in patients treated with this regimen
Determine the toxic effects of this regimen in these patients
Determine the quality of life of patients treated with this regimen
OUTLINE Patients are stratified according to tumor status severely debilitating andor life-threatening vs cosmetically disfiguring
Patients receive methotrexate and vinblastine IV weekly for 26 weeks and then every 2 weeks for 26 weeks in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at baseline and then every 3 months during study participation
Patients are followed every 3 months until disease progression
PROJECTED ACCRUAL A total of 35 patients will be accrued for this study within approximately 3 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 |
|---|---|---|---|
| CHP-686 | OTHER | Childrens Hospital of Philadelphia | None |