Ignite Creation Date:
2024-05-05 @ 11:36 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00087074
Status:
COMPLETED
Last Update Posted:
2013-06-04
First Post:
2004-07-08
Brief Title:
CCI-779 in Treating Patients With Soft Tissue Sarcoma or Gastrointestinal Stromal Tumor
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Trial of CCI-779 in Patients With Soft Tissue Sarcoma
Status:
COMPLETED
Status Verified Date:
2013-06
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 CCI-779 works in treating patients with soft tissue sarcoma or gastrointestinal stromal tumor Drugs used in chemotherapy such as CCI-779 work in different ways to stop tumor cells from dividing so they stop growing or die
Detailed Description:
PRIMARY OBJECTIVES
I To assess the antitumor activity of CCI-779 in this patient population
SECONDARY OBJECTIVES
I To assess the following in patients with soft tissue sarcomas and following treatment with CCI-779 duration of response time to progression survival
TERTIARY OBJECTIVES
I To describe and correlate the following with patient characteristics and outcome in this patient population and following treatment with CCI-779 relative levels of 4EBP1 to eIF4E phospho 4EBP1 total and phospho ribosomal S6 on pretreatment tumor tissue expression levels of EGFR activated EGFR Her2 c-Myc phospho Akt total Akt phospho-mTOR and total mTOR on pretreatment tumor tissue drug induced inhibition of p70S6 kinase activity and phosphorylation of S6 in PBMC relative levels of serum sirolimus in post-treatment samples
OUTLINE
Patients receive CCI-779 IV over 30 minutes on days 1 8 15 and 22 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity Patients achieving a complete response CR receive 2 additional courses beyond CR
Patients are followed every 3 months for 1 year every 4 months for 1 year and then every 6 months for 3 years
I To assess the antitumor activity of CCI-779 in this patient population
SECONDARY OBJECTIVES
I To assess the following in patients with soft tissue sarcomas and following treatment with CCI-779 duration of response time to progression survival
TERTIARY OBJECTIVES
I To describe and correlate the following with patient characteristics and outcome in this patient population and following treatment with CCI-779 relative levels of 4EBP1 to eIF4E phospho 4EBP1 total and phospho ribosomal S6 on pretreatment tumor tissue expression levels of EGFR activated EGFR Her2 c-Myc phospho Akt total Akt phospho-mTOR and total mTOR on pretreatment tumor tissue drug induced inhibition of p70S6 kinase activity and phosphorylation of S6 in PBMC relative levels of serum sirolimus in post-treatment samples
OUTLINE
Patients receive CCI-779 IV over 30 minutes on days 1 8 15 and 22 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity Patients achieving a complete response CR receive 2 additional courses beyond CR
Patients are followed every 3 months for 1 year every 4 months for 1 year and then every 6 months 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 |
|---|---|---|---|
| N01CM17104 | NIH | None | httpsreporternihgovquickSearchN01CM17104 |
| MC027B | None | None | None |