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potentiation of the killing of lymphoma cells when GCS-100 is combined with dexamethasone or etoposide (Linda Baum, unpublished data; Finbarr Cotter et al, Annals of Oncology, vol 16, 205, Suppl 5.)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


Study is Available At:


Original ID:

PR-CS010


NCT ID:

NCT00776802


Secondary ID:


Study Acronym:

GCS-100LE


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:

Withdrawn


Study Phase:

Phase 1/Phase 2


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


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:

Interventional


Study Design:

Endpoint Classification: Safety Study, Interventi


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

0


Enrollment Type:

Actual


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
Name:GCS-100
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

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