SL-11047 in Treating Patients With Relapsed or Refractory Lymphoma
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|ClinicalTrials.gov Identifier: NCT00293488|
Recruitment Status : Completed
First Posted : February 17, 2006
Last Update Posted : June 23, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma||Drug: polyamine analogue PG11047||Phase 1|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Masking:||None (Open Label)|
|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|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00293488
|United States, California|
|UCSF Helen Diller Family Comprehensive Cancer Center|
|San Francisco, California, United States, 94115|
|OverallOfficial:||Barbara Hicks||Progen Pharmaceuticals|