Ignite Creation Date:
2024-05-05 @ 10:05 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004002
Status:
COMPLETED
Last Update Posted:
2012-11-09
First Post:
1999-11-01
Brief Title:
PS-341 in Treating Patients With Advanced Solid Tumors or Lymphoma
Sponsor:
NYU Langone Health
Organization:
NYU Langone Health
Study Overview
Official Title:
Phase I Trial of PS-341 in Advanced Cancers
Status:
COMPLETED
Status Verified Date:
2005-09
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 Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die
PURPOSE Phase I trial to study the effectiveness of PS-341 in treating patients who have advanced solid tumors or lymphoma that have not responded to previous treatment
PURPOSE Phase I trial to study the effectiveness of PS-341 in treating patients who have advanced solid tumors or lymphoma that have not responded to previous treatment
Detailed Description:
OBJECTIVES I Determine the dose-limiting toxicity and maximum tolerated dose of PS-341 in patients with advanced solid tumors or lymphoma II Evaluate the pharmacodynamics of this drug by measuring 20S proteasome inhibition in these patients III Assess changes in P53 or P27 and possibly E2F-1 and cyclin E in patients with lymphoma in response to this drug IV Evaluate objective tumor response to this drug in these patients V Evaluate the relationship between toxicity and 20S proteasome inhibition in blood and in accessible tumor tissue in these patients VI Evaluate response to treatment with this drug in patients with measurable or evaluable disease
OUTLINE This is a dose-escalation multicenter study Patients receive PS-341 IV on days 1 and 4 Treatment repeats every 14 days for at least 2 courses in the absence of unacceptable toxicity or disease progression Patients with stable or responding disease may receive additional courses at the discretion of the treating physician Cohorts of 3-6 patients receive escalating doses of PS-341 until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which 2 of 3 or 6 patients experience dose-limiting toxicity Patients are followed at 4 weeks
PROJECTED ACCRUAL A maximum of 27 patients will be accrued for this study
OUTLINE This is a dose-escalation multicenter study Patients receive PS-341 IV on days 1 and 4 Treatment repeats every 14 days for at least 2 courses in the absence of unacceptable toxicity or disease progression Patients with stable or responding disease may receive additional courses at the discretion of the treating physician Cohorts of 3-6 patients receive escalating doses of PS-341 until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which 2 of 3 or 6 patients experience dose-limiting toxicity Patients are followed at 4 weeks
PROJECTED ACCRUAL A maximum of 27 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 |
|---|---|---|---|
| NCI-T99-0047 | None | None | None |
| NYU-9909 | None | None | None |