GCS-100LE in Combination With Etoposide and Dexamethasone in Relapsed or Refractory Diffuse Large B-Cell Lymphoma

Withdrawn before enrolling · Phase 1/Phase 2

Conditions studied: Diffuse Large B-cell Lymphoma

In brief

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.

Key facts

Study ID

NCT00776802

Run by

La Jolla Pharmaceutical Company

People needed

0

Starts

2008-07-01

Expected to finish

2009-04-01

Last updated by the study team

2013-06-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• UCLA Medical Center — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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