GCS-100LE in Combination With Etoposide and Dexamethasone in Relapsed or Refractory Diffuse Large B-Cell Lymphoma
- Conditions
- Diffuse Large B-cell Lymphoma
- Interventions
- Registration Number
- NCT00776802
- Lead Sponsor
- La Jolla Pharmaceutical Company
- Brief Summary
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.
- Detailed Description
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potentiation of the killing of lymphoma cells when GCS-100 is combined with dexamethasone or etoposide (Linda Baum, unpublished data; Finbarr Cotter et al, Annals of Oncology, vol 16, 205, Suppl 5.)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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
-
Male or female patients who are 18 years of age or older with diffuse large B-cell cell lymphoma (DLBCL) relapsed or refractory after initial therapy who:
- Are not candidates for autologous stem cell transplant.
- Have relapsed after autologous or allogeneic stem cell transplant.
- Have relapsed or refractory disease after 3 successive chemotherapy regimens.
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ECOG Performance Score 0-2
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Creatinine clearance > 60 mL/min/1.73 m2.
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Total bilirubin ≤2.0 X Institutional Upper Limit of Normal (IULN)
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AST (SGOT)/ALT (SGPT) ≤2.5 X IUNL, or ≤5X IUNL in patients with liver involvement of DLBCL
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Absolute neutrophil count >1,000 /_L; hemoglobin >9 g/mL; platelet count > 75,000 /_L at screening.
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Patients must be capable of understanding the purpose and risks of the study and able to provide written consent.
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Patients must be willing and able to comply with the prescribed treatment protocol and evaluations
- Treatment with experimental (unlicensed) drug within 3 weeks of treatment.
- Previous chemotherapy, or major surgery within 21 days prior to first study treatment, or radiation therapy within 6 weeks.
- Rapidly progressive disease or organ function threatened by disease
- Serious, uncontrolled active infections.
- Serologically positive for HIV, HBV, or HCV.
- Clinically significant cardiac, pulmonary, and/or hepatic dysfunction
- Lymphoma involving the central nervous system
- Female patients who are pregnant or breast feeding.
- Patients not capable of understanding the purpose and risks of the study and or unable to provide written consent.
- Patients not willing and or unable to comply with the prescribed treatment protocol and evaluations
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description GCS-10 Etoposide; Dexamethasone - GCS-10 GCS-100 -
- Primary Outcome Measures
Name Time Method 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. Study Day 12 for toxicity, and 21-day cycles assessed every 2 cycles by physical and imaging assessments until disease progression
- Secondary Outcome Measures
Name Time Method 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 Baseline, Day 1, and Day 5 laboratory assessments
Trial Locations
- Locations (1)
UCLA Medical Center
🇺🇸Los Angeles, California, United States