Ignite Creation Date:
2024-05-05 @ 4:41 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00293488
Status:
COMPLETED
Last Update Posted:
2016-06-23
First Post:
2006-02-16
Brief Title:
SL-11047 in Treating Patients With Relapsed or Refractory Lymphoma
Sponsor:
Progen Pharmaceuticals
Organization:
Progen Pharmaceuticals
Study Overview
Official Title:
An Open Label Phase I Study Evaluating Safety Tolerability and Pharmacokinetics of SL-11047 in Patients With Refractory Lymphoma
Status:
COMPLETED
Status Verified Date:
2016-06
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 Drugs used in chemotherapy such as SL-11047 work in different ways to stop the growth of cancer cells either by killing the cells or by stopping them from dividing
PURPOSE This phase I trial is studying the side effects and best dose of SL-11047 in treating patients with relapsed or refractory lymphoma
PURPOSE This phase I trial is studying the side effects and best dose of SL-11047 in treating patients with relapsed or refractory lymphoma
Detailed Description:
OBJECTIVES
Primary
Determine the maximum tolerated dose MTD of SL-11047 in patients with relapsed or refractory lymphoma
Describe and quantify the toxicity of SL-11047 administered to patients with relapsed or refractory lymphoma
Secondary
Describe the pharmacokinetics of SL-11047 administered as a 30-minute IV infusion
Assess the response rate and duration of response in patients treated with SL-11047
Assess the level of SL-11047 within tumor tissues following intravenous administration of the drug
Determine the sensitivity of abnormal circulating macrophages to SL-11047
OUTLINE This is an open-label nonrandomized dose-escalation study
Patients receive SL-11047 IV over 30 minutes on days 1-5 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of SL-11047 until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
After completion of study treatment patients are followed periodically
PROJECTED ACCRUAL A total of 20 patients will be accrued for this study
Primary
Determine the maximum tolerated dose MTD of SL-11047 in patients with relapsed or refractory lymphoma
Describe and quantify the toxicity of SL-11047 administered to patients with relapsed or refractory lymphoma
Secondary
Describe the pharmacokinetics of SL-11047 administered as a 30-minute IV infusion
Assess the response rate and duration of response in patients treated with SL-11047
Assess the level of SL-11047 within tumor tissues following intravenous administration of the drug
Determine the sensitivity of abnormal circulating macrophages to SL-11047
OUTLINE This is an open-label nonrandomized dose-escalation study
Patients receive SL-11047 IV over 30 minutes on days 1-5 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of SL-11047 until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
After completion of study treatment patients are followed periodically
PROJECTED ACCRUAL A total of 20 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 |
|---|---|---|---|
| UCSF-SL002 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000463738 | REGISTRY | None | None |
| UCSF-H1956-21906-02 | None | None | None |