DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Information source: La Jolla Pharmaceutical Company
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Diffuse Large B-cell Lymphoma

Intervention: GCS-100 (Drug); Etoposide; Dexamethasone (Drug)

Phase: Phase 1/Phase 2

Status: Withdrawn

Sponsored by: La Jolla Pharmaceutical Company

Official(s) and/or principal investigator(s):
Lauren Pinter-Brown, MD, Principal Investigator, Affiliation: UCLA, Division of Hematology/Oncology

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.

Clinical Details

Official title: Phase 1/2 Study of GCS-100 in Combination With Etoposide and Dexamethasone in Relapsed or Refractory Diffuse Large B Cell Lymphoma

Study design: Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: To determine the maximum tolerated dose of GCS-100 in combination with etoposide and dexamethasone by comprehensive lab, pharmacokinetics, physical assessments, and PET-CT imaging.

Secondary outcome: Overall response rate; correlate response to GCS-100 with the expression of galectin-3 in tumors; correlate serum galectin-3 levels with the administration of GCS-100

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potentiation of the killing of lymphoma cells when GCS-100 is combined with dexamethasone or etoposide (Linda Baum, unpublished data; Finbarr Cotter et al, Annals of Oncology, vol 16, 205, Suppl 5.)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

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

UCLA Medical Center, Los Angeles, California 90095, United States
Additional Information

Starting date: July 2008
Last updated: June 21, 2013

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017