Status:
WITHDRAWN
GCS-100LE in Combination With Etoposide and Dexamethasone in Relapsed or Refractory Diffuse Large B-Cell Lymphoma
Lead Sponsor:
La Jolla Pharmaceutical Company
Conditions:
Diffuse Large B-cell Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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-ce...
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-10...
Eligibility Criteria
Inclusion
- 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.
- ECOG Performance Score 0-2
- Creatinine clearance \> 60 mL/min/1.73 m2.
- Total bilirubin ≤2.0 X Institutional Upper Limit of Normal (IULN)
- AST (SGOT)/ALT (SGPT) ≤2.5 X IUNL, or ≤5X IUNL in patients with liver involvement of DLBCL
- Absolute neutrophil count \>1,000 /\_L; hemoglobin \>9 g/mL; platelet count \> 75,000 /\_L at screening.
- Patients must be capable of understanding the purpose and risks of the study and able to provide written consent.
- Patients must be willing and able to comply with the prescribed treatment protocol and evaluations
Exclusion
- 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
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2009
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00776802
Start Date
July 1 2008
End Date
April 1 2009
Last Update
June 25 2013
Active Locations (1)
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1
UCLA Medical Center
Los Angeles, California, United States, 90095