SL-11047 in Treating Patients With Relapsed or Refractory Lymphoma
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.
|Study Design:||Allocation: Non-Randomized
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open Label Phase I Study Evaluating Safety, Tolerability and Pharmacokinetics of SL-11047 in Patients With Refractory Lymphoma|
|Study Start Date:||January 2006|
|Primary Completion Date:||September 2008 (Final data collection date for primary outcome measure)|
- 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.
- 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.
|United States, California|
|UCSF Helen Diller Family Comprehensive Cancer Center|
|San Francisco, California, United States, 94115|
|Investigator:||Barbara Hicks||Progen Pharmaceuticals|