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

This study has been withdrawn prior to enrollment.
(Lack of funding)
Sponsor:
Information provided by (Responsible Party):
La Jolla Pharmaceutical Company
ClinicalTrials.gov Identifier:
NCT00776802
First received: October 19, 2008
Last updated: June 21, 2013
Last verified: June 2013
  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.


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

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by La Jolla Pharmaceutical Company:

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. [ Time Frame: Study Day 12 for toxicity, and 21-day cycles assessed every 2 cycles by physical and imaging assessments until disease progression ] [ Designated as safety issue: Yes ]

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 [ Time Frame: Baseline, Day 1, and Day 5 laboratory assessments ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: July 2008
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: La Jolla Pharmaceutical Company
ClinicalTrials.gov Identifier: NCT00776802     History of Changes
Other Study ID Numbers: PR-CS010
Study First Received: October 19, 2008
Last Updated: June 21, 2013
Health Authority: United States: Food and Drug Administration

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
Dexamethasone 21-phosphate
Etoposide phosphate
Etoposide
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents

ClinicalTrials.gov processed this record on April 16, 2014