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

June 21, 2013 updated by: La Jolla Pharmaceutical Company

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

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 Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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potentiation of the killing of lymphoma cells when GCS-100 is combined with dexamethasone or etoposide (Linda Baum, unpublished data; Finbarr Cotter et al, Annals of Oncology, vol 16, 205, Suppl 5.)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

Study Type

Interventional

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90095
        • UCLA Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: GCS-10
Drug: GCS-100
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
Drug: Etoposide; Dexamethasone
Etoposide 100 mg/m2 on Study Days 3, 4 and 5; Dexamethasone 10 mg/m2 on Study Days 1, 2, 3, 4 and 5.
Other Names:
  • Decadron
  • Vepesid
  • VP-16
  • Eposin
  • Etopophos

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Study Day 12 for toxicity, and 21-day cycles assessed every 2 cycles by physical and imaging assessments until disease progression

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Baseline, Day 1, and Day 5 laboratory assessments

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

La Jolla Pharmaceutical Company

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2008

Primary Completion (Actual)

April 1, 2009

Study Completion (Actual)

April 1, 2009

Study Registration Dates

First Submitted

October 19, 2008

First Submitted That Met QC Criteria

October 20, 2008

First Posted (Estimate)

October 21, 2008

Study Record Updates

Last Update Posted (Estimate)

June 25, 2013

Last Update Submitted That Met QC Criteria

June 21, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PR-CS010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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