Trials / Completed
CompletedNCT00293488
SL-11047 in Treating Patients With Relapsed or Refractory Lymphoma
An Open Label Phase I Study Evaluating Safety, Tolerability and Pharmacokinetics of SL-11047 in Patients With Refractory Lymphoma
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- Sponsor
- Progen Pharmaceuticals · Industry
- Sex
- All
- Age
- 18 Years – 120 Years
- Healthy volunteers
- Not accepted
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.
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | polyamine analogue PG11047 |
Timeline
- Start date
- 2006-01-01
- Primary completion
- 2008-09-01
- First posted
- 2006-02-17
- Last updated
- 2016-06-23
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00293488. Inclusion in this directory is not an endorsement.