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

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ClinicalTrials.gov Identifier: NCT00776802
Recruitment Status : Withdrawn (Lack of funding)
First Posted : October 21, 2008
Last Update Posted : June 25, 2013
Sponsor:
Information provided by (Responsible Party):
La Jolla Pharmaceutical Company

Study Description
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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.

Condition or disease Intervention/treatment Phase
Diffuse Large B-cell Lymphoma Drug: GCS-100 Drug: Etoposide; Dexamethasone Phase 1 Phase 2

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potentiation of the killing of lymphoma cells when GCS-100 is combined with dexamethasone or etoposide (Linda Baum, unpublished data; Finbarr Cotter et al, Annals of Oncology, vol 16, 205, Suppl 5.)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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : July 2008
Actual Primary Completion Date : April 2009
Actual Study Completion Date : April 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arms and Interventions
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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:
  • Eposin
  • VP-16
  • Etopophos
  • Vepesid
  • Decadron


Outcome Measures
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Primary Outcome Measures :
  1. 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 Measures :
  1. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00776802


Locations
United States, California
UCLA Medical Center
Los Angeles, California, United States, 90095
Sponsors and Collaborators
La Jolla Pharmaceutical Company
Investigators
Principal Investigator: Lauren Pinter-Brown, MD UCLA, Division of Hematology/Oncology
More Information
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Responsible Party: La Jolla Pharmaceutical Company
ClinicalTrials.gov Identifier: NCT00776802     History of Changes
Other Study ID Numbers: PR-CS010
First Posted: October 21, 2008    Key Record Dates
Last Update Posted: June 25, 2013
Last Verified: June 2013

Keywords provided by La Jolla Pharmaceutical Company:
GCS-100
Diffuse Large B-cell Lymphoma
DLBCL
Relapsed or refractory DLBCL
Etoposide; Dexamethasone

Additional relevant MeSH terms:
Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Dexamethasone acetate
Dexamethasone
Etoposide phosphate
Etoposide
BB 1101
 Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic