GCS-100LE in Combination With Etoposide and Dexamethasone in Relapsed or Refractory Diffuse Large B-Cell Lymphoma
Phase 1/2, open-label, dose-escalation study to assess the safety and tolerability of GCS-100 in combination with etoposide and dexamethasone in patients with relapsed or refractory diffuse large B-cell lymphoma.
Diffuse Large B-cell Lymphoma
Drug: Etoposide; Dexamethasone
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase 1/2 Study of GCS-100 in Combination With Etoposide and Dexamethasone in Relapsed or Refractory Diffuse Large B Cell Lymphoma|
- To determine the maximum tolerated dose of GCS-100 in combination with etoposide and dexamethasone by comprehensive lab, pharmacokinetics, physical assessments, and PET-CT imaging. [ Time Frame: Study Day 12 for toxicity, and 21-day cycles assessed every 2 cycles by physical and imaging assessments until disease progression ] [ Designated as safety issue: Yes ]
- Overall response rate; correlate response to GCS-100 with the expression of galectin-3 in tumors; correlate serum galectin-3 levels with the administration of GCS-100 [ Time Frame: Baseline, Day 1, and Day 5 laboratory assessments ] [ Designated as safety issue: No ]
|Study Start Date:||July 2008|
|Study Completion Date:||April 2009|
|Primary Completion Date:||April 2009 (Final data collection date for primary outcome measure)|
GCS-100 80 mg/m2 IV (in the vein) on Study Days 1, 2, 3, 4, and 5 of a 21-day course. Three or up to six patients will be enrolled in each cohort until the maximum tolerated dose is reached. The dose levels: 1) 80 mg/m2; 2) 120 mg/m2; 3) 160 mg/m2Drug: Etoposide; Dexamethasone
Etoposide 100 mg/m2 on Study Days 3, 4 and 5; Dexamethasone 10 mg/m2 on Study Days 1, 2, 3, 4 and 5.
This study will investigate the safety and efficacy of the combination of GCS-100 with etoposide and dexamethasone. In vitro data demonstrates potentiation of the killing of lymphoma cells when GCS-100 is combined with dexamethasone or etoposide (Linda Baum, unpublished data; Finbarr Cotter et al, Annals of Oncology, vol 16, 205, Suppl 5.) GCS-100 will be administered in increasing doses to define a maximum tolerated dose (MTD) in combination with these chemotherapeutic agents. When the MTD is defined, the cohort will be expanded to characterize the efficacy of this combination.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00776802
|United States, California|
|UCLA Medical Center|
|Los Angeles, California, United States, 90095|
|Principal Investigator:||Lauren Pinter-Brown, MD||UCLA, Division of Hematology/Oncology|