Ignite Creation Date:
2024-05-05 @ 11:36 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00085475
Status:
COMPLETED
Last Update Posted:
2012-09-24
First Post:
2004-06-10
Brief Title:
Imatinib Mesylate in Treating Patients With Locally Advanced or Metastatic Dermatofibrosarcoma Protuberans or Giant Cell Fibroblastoma
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Organization:
European Organisation for Research and Treatment of Cancer - EORTC
Study Overview
Official Title:
Phase II Study of Glivec Imatinib in Locally Advanced andor Metastatic Soft Tissue Sarcomas Expressing the t1722q22q13 Translocation Resulting in a COL1A1PDGF-beta Fusion Protein ie DermatoFibroSarcoma Protuberans DFSP and Giant Cell Fibroblastoma GCF
Status:
COMPLETED
Status Verified Date:
2012-09
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 Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for their growth
PURPOSE This phase II trial is studying how well imatinib mesylate works in treating patients with locally advanced or metastatic dermatofibrosarcoma protuberans or giant cell fibroblastoma
PURPOSE This phase II trial is studying how well imatinib mesylate works in treating patients with locally advanced or metastatic dermatofibrosarcoma protuberans or giant cell fibroblastoma
Detailed Description:
OBJECTIVES
Primary
Determine the therapeutic activity of imatinib mesylate in patients with locally advanced or metastatic dermatofibrosarcoma protuberans or giant cell fibroblastoma
Determine the progression-free rate at 14 weeks in patients treated with this drug
Secondary
Determine objective response rate progression-free survival and overall survival in patients treated with this drug
Determine the duration of response in patients treated with this drug
OUTLINE This is an open-label non-randomized multicenter study
Patients receive oral imatinib mesylate twice daily for at least 14 weeks in the absence of disease progression or unacceptable toxicity Patients with stable disease after 14 weeks receive imatinib mesylate for 12 additional weeks Patients with a partial or complete response at 14 weeks undergo surgical resection if possible If surgical resection of all remaining tumor is not possible OR if complete resection is not achieved section margins positive patients continue to receive imatinib mesylate in the absence of disease progression
Patients are followed monthly for 6 months every 3 months for 6 months every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL A total of 44 patients will be accrued for this study within 2 years
Primary
Determine the therapeutic activity of imatinib mesylate in patients with locally advanced or metastatic dermatofibrosarcoma protuberans or giant cell fibroblastoma
Determine the progression-free rate at 14 weeks in patients treated with this drug
Secondary
Determine objective response rate progression-free survival and overall survival in patients treated with this drug
Determine the duration of response in patients treated with this drug
OUTLINE This is an open-label non-randomized multicenter study
Patients receive oral imatinib mesylate twice daily for at least 14 weeks in the absence of disease progression or unacceptable toxicity Patients with stable disease after 14 weeks receive imatinib mesylate for 12 additional weeks Patients with a partial or complete response at 14 weeks undergo surgical resection if possible If surgical resection of all remaining tumor is not possible OR if complete resection is not achieved section margins positive patients continue to receive imatinib mesylate in the absence of disease progression
Patients are followed monthly for 6 months every 3 months for 6 months every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL A total of 44 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 |
|---|---|---|---|
| EUDRACT-2004-002538-20 | None | None | None |
| EORTC-62027 | None | None | None |