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Withdrawn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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Diffuse Large B-cell Lymphoma | Drug: GCS-100 Drug: Etoposide; Dexamethasone | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 0 participants |
Allocation: | N/A |
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 |

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:
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- 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 ]
- 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 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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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

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
United States, California | |
UCLA Medical Center | |
Los Angeles, California, United States, 90095 |
Principal Investigator: | Lauren Pinter-Brown, MD | UCLA, Division of Hematology/Oncology |
Responsible Party: | La Jolla Pharmaceutical Company |
ClinicalTrials.gov Identifier: | NCT00776802 |
Other Study ID Numbers: |
PR-CS010 |
First Posted: | October 21, 2008 Key Record Dates |
Last Update Posted: | June 25, 2013 |
Last Verified: | June 2013 |
GCS-100 Diffuse Large B-cell Lymphoma DLBCL Relapsed or refractory DLBCL Etoposide; Dexamethasone |
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 Etoposide 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 Antineoplastic Agents, Phytogenic Topoisomerase II Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |