Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Los Angeles, California 90095


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potentiation of the killing of lymphoma cells when GCS-100 is combined with dexamethasone or etoposide (Linda Baum, unpublished data; Finbarr Cotter et al, Annals of Oncology, vol 16, 205, Suppl 5.)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


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

Study is Available At:

Original ID:




Secondary ID:

Study Acronym:


Brief Title:

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

Official Title:

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

Overall Status:


Study Phase:

Phase 1/Phase 2



Minimum Age:

18 Years

Maximum Age:


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

La Jolla Pharmaceutical Company

Oversight Authority:

United States: Food and Drug Administration

Reasons Why Stopped:

Lack of funding

Study Type:


Study Design:

Endpoint Classification: Safety Study, Interventi

Number of Arms:


Number of Groups:


Total Enrollment:


Enrollment Type:


Overall Contact Information

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

Study Dates

Start Date:July 2008
Completion Date:April 2009
Completion Type:Actual
Primary Completion Date:April 2009
Primary Completion Type:Actual
Verification Date:June 2013
Last Changed Date:June 21, 2013
First Received Date:October 19, 2008

Study Outcomes

Outcome Type:Secondary Outcome
Measure: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
Time Frame:Baseline, Day 1, and Day 5 laboratory assessments
Safety Issues:False
Outcome Type:Primary Outcome
Measure: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.
Time Frame:Study Day 12 for toxicity, and 21-day cycles assessed every 2 cycles by physical and imaging assessm
Safety Issues:True

Study Interventions

Intervention Type:Drug
Description:GCS-100 80 mg/m2 IV (in the vein) on Study Days 1, 2, 3, 4, and 5 of a 21-day course. Three or up to six patients will be enrolled in each cohort until the maximum tolerated dose is reached. The dose levels: 1) 80 mg/m2; 2) 120 mg/m2; 3) 160 mg/m2
Arm Name:GCS-10
Intervention Type:Drug
Name:Etoposide; Dexamethasone
Description:Etoposide 100 mg/m2 on Study Days 3, 4 and 5; Dexamethasone 10 mg/m2 on Study Days 1, 2, 3, 4 and 5.
Arm Name:GCS-10
Other Name:Eposin

Study Arms

Study Arm Type:Experimental
Arm Name:GCS-10

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:La Jolla Pharmaceutical Company

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.

This study is not currently recruiting Study Participants. The form below is not enabled.