Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006098
Status:
COMPLETED
Last Update Posted:
2013-06-18
First Post:
2000-08-03
Brief Title:
PS-341 in Treating Patients With Hematologic Cancer
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
A Phase I Study of PS-341 in Patients With Hematologic Malignancies
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:
RATIONALE PS-341 may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth
PURPOSE Phase I trial to study the effectiveness of PS-341 in treating patients who have hematologic cancer
PURPOSE Phase I trial to study the effectiveness of PS-341 in treating patients who have hematologic cancer
Detailed Description:
OBJECTIVES I Determine the maximum tolerated dose and dose-limiting toxicity of PS-341 in patients with hematologic malignancies II Determine the pharmacodynamics of this drug in these patients III Determine response to this drug in these patients IV Determine the correlation between response of malignancies and proteasome inhibition and apoptosis in peripheral blood mononuclear cells PBMC of these patients V Determine the correlation between therapy toxicity and proteasome inhibition and apoptosis in PBMC of these patients VI Determine the effect of this drug on other molecular markers ie BCL-2 in follicular lymphoma patients and t922BCRABL in chronic lymphocytic leukemia patients VII Determine the correlation between interleukin-6 serum levels in multiple myeloma patients and drug dosing toxicity of therapy extent of protease inhibition response to therapy and apoptosis in PBMC of these patients
OUTLINE This is a dose-escalation multicenter study Patients receive PS-341 IV over 30 minutes on days 1 4 8 11 15 18 22 and 25 followed by a 2-week rest Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity 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 6 patients experience dose-limiting toxicity
PROJECTED ACCRUAL A total of 3-30 patients will be accrued for this study
OUTLINE This is a dose-escalation multicenter study Patients receive PS-341 IV over 30 minutes on days 1 4 8 11 15 18 22 and 25 followed by a 2-week rest Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity 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 6 patients experience dose-limiting toxicity
PROJECTED ACCRUAL A total of 3-30 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-G00-1827 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000068105 | REGISTRY | None | None |