SL-11047 in Treating Patients With Relapsed or Refractory Lymphoma
- Conditions
- Lymphoma
- Registration Number
- NCT00293488
- Lead Sponsor
- Progen Pharmaceuticals
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
UCSF Helen Diller Family Comprehensive Cancer Center
🇺🇸San Francisco, California, United States