Expired Study
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Los Angeles, California 90095


Purpose:

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.


Study summary:

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potentiation of the killing of lymphoma cells when GCS-100 is combined with dexamethasone or etoposide (Linda Baum, unpublished data; Finbarr Cotter et al, Annals of Oncology, vol 16, 205, Suppl 5.)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


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


NCT ID:

NCT00776802


Primary Contact:

Principal Investigator
Lauren Pinter-Brown, MD
UCLA, Division of Hematology/Oncology


Backup Contact:

N/A


Location Contact:

Los Angeles, California 90095
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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