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

La Jolla Pharmaceutical

Status and phase

Withdrawn

Phase 2

Phase 1

Conditions

Diffuse Large B-cell Lymphoma

Treatments

Drug: Etoposide; Dexamethasone

Drug: GCS-100

Study type

Interventional

Funder types

Industry

Identifiers

NCT00776802

PR-CS010

Details and patient eligibility

About

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.

Full 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potentiation of the killing of lymphoma cells when GCS-100 is combined with dexamethasone or etoposide (Linda Baum, unpublished data; Finbarr Cotter et al, Annals of Oncology, vol 16, 205, Suppl 5.)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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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