Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00084630
Status:
COMPLETED
Last Update Posted:
2013-02-28
First Post:
2004-06-10
Brief Title:
Imatinib Mesylate in Treating Patients With Locally Recurrent or Metastatic Dermatofibrosarcoma Protuberans
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Study of Imatinib NSC-716051 in Patients With Locally Advanced or Metastatic Dermatofibrosarcoma Protuberans
Status:
COMPLETED
Status Verified Date:
2013-02
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:
This phase II trial is studying how well imatinib mesylate works in treating patients with locally recurrent or metastatic dermatofibrosarcoma protuberans DFSP or transformed fibrosarcomatous DFSP a type of soft tissue sarcoma Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for their growth
Detailed Description:
PRIMARY OBJECTIVES
I To assess the response rate confirmed complete and confirmed partial response in patients with locally advanced or metastatic dermatofibrosarcoma protuberans DFSP treated with imatinib
II To estimate the one-year progression-free survival probability in this population when treated with imatinib
III To evaluate the frequency and severity of toxicities associated with this treatment
IV To measure the presence of PDGFB gene rearrangement in DFSP detectable by RT-PCR for COL1A1-PDGFB fusions andor FISH PDGFB rearrangements with unknown partners and explore relationships between these measures and survival and tumor response in a preliminary manner
V To investigate in a preliminary fashion the correlation of plasma levels of imatinib after 1 month of treatment with the response of DFSP
VI To obtain tumor material for additional future correlative studies of the activity of intracellular kinases cDNA microarray analyses and PDGFB receptor gene sequence analyses
OUTLINE
Patients receive oral imatinib mesylate once daily on days 1-56 Treatment repeats every 56 days for 6 courses in the absence of disease progression or unacceptable toxicity Patients with documented tumor progression and no serious side effects may continue therapy at a higher dose for another 6 courses
Patients are followed every 6 months for 2 years and then annually for 3 years
I To assess the response rate confirmed complete and confirmed partial response in patients with locally advanced or metastatic dermatofibrosarcoma protuberans DFSP treated with imatinib
II To estimate the one-year progression-free survival probability in this population when treated with imatinib
III To evaluate the frequency and severity of toxicities associated with this treatment
IV To measure the presence of PDGFB gene rearrangement in DFSP detectable by RT-PCR for COL1A1-PDGFB fusions andor FISH PDGFB rearrangements with unknown partners and explore relationships between these measures and survival and tumor response in a preliminary manner
V To investigate in a preliminary fashion the correlation of plasma levels of imatinib after 1 month of treatment with the response of DFSP
VI To obtain tumor material for additional future correlative studies of the activity of intracellular kinases cDNA microarray analyses and PDGFB receptor gene sequence analyses
OUTLINE
Patients receive oral imatinib mesylate once daily on days 1-56 Treatment repeats every 56 days for 6 courses in the absence of disease progression or unacceptable toxicity Patients with documented tumor progression and no serious side effects may continue therapy at a higher dose for another 6 courses
Patients are followed every 6 months for 2 years and then annually for 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 |
|---|---|---|---|
| S0345 | None | None | None |
| U10CA032102 | NIH | None | None |
| CDR0000365465 | REGISTRY | PDQ Physician Data Query | httpsreporternihgovquickSearchU10CA032102 |