A Phase 1 interventional study of polyamine analogue PG11047 in Lymphoma, sponsored by Progen Pharmaceuticals. Completed at 1 site in United States. Open to participants aged 18 Years to 120 Years. Per ClinicalTrials.gov, last updated 2016-06-23.
Sponsored by Progen Pharmaceuticals · Phase 1, Interventional, and Treatment
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.
OBJECTIVES:
Primary
Secondary
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.
5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.
This study's planned enrollment of 20 is below the median of 40 across 4,508 interventional studies indexed under Lymphoma.
Browse Lymphoma studies →Progen Pharmaceuticals is the lead sponsor of 6 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
Histologically* confirmed Hodgkin's or non-Hodgkin's lymphoma (NHL) of any histology
The following NHL types are eligible:
PATIENT CHARACTERISTICS:
No significant ventricular conduction abnormality by ECG or Holter monitoring, as evidenced by any of the following:
No history of recent gastrointestinal bleeding
NOTE: **Elevated due to direct lymphomatous involvement allowed
PRIOR CONCURRENT THERAPY:
This study is completed, as verified in Jun 2016. You cannot join it, but the record below documents what was studied.
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Progen Pharmaceuticals