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

Primary Purpose

Diffuse Large B-cell Lymphoma

Status
Withdrawn
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
GCS-100
Etoposide; Dexamethasone
Sponsored by
La Jolla Pharmaceutical Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diffuse Large B-cell Lymphoma focused on measuring GCS-100, Diffuse Large B-cell Lymphoma, DLBCL, Relapsed or refractory DLBCL, Etoposide; Dexamethasone

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • UCLA Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

GCS-10

Arm Description

Outcomes

Primary Outcome Measures

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 Measures

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

Full Information

First Posted
October 19, 2008
Last Updated
June 21, 2013
Sponsor
La Jolla Pharmaceutical Company
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1. Study Identification

Unique Protocol Identification Number
NCT00776802
Brief Title
GCS-100LE in Combination With Etoposide and Dexamethasone in Relapsed or Refractory Diffuse Large B-Cell Lymphoma
Acronym
GCS-100LE
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 Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Withdrawn
Why Stopped
Lack of funding
Study Start Date
July 2008 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
April 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
La Jolla Pharmaceutical Company

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diffuse Large B-cell Lymphoma
Keywords
GCS-100, Diffuse Large B-cell Lymphoma, DLBCL, Relapsed or refractory DLBCL, Etoposide; Dexamethasone

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
GCS-10
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
GCS-100
Intervention 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
Intervention Type
Drug
Intervention Name(s)
Etoposide; Dexamethasone
Other Intervention Name(s)
Eposin, VP-16, Etopophos, Vepesid, Decadron
Intervention 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.
Primary Outcome Measure Information:
Title
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 assessments until disease progression
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lauren Pinter-Brown, MD
Organizational Affiliation
UCLA, Division of Hematology/Oncology
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCLA Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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