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

• Status: Withdrawn
• Trial end date: 2009-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: La Jolla Pharmaceutical Company
• Treatments: BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Etoposide; Etoposide phosphate

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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