GCS-100LE in Combination With Etoposide and Dexamethasone in Relapsed or Refractory Diffuse Large B-Cell Lymphoma
Information source: La Jolla Pharmaceutical Company
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Diffuse Large B-cell Lymphoma
Intervention: GCS-100 (Drug); Etoposide; Dexamethasone (Drug)
Phase: Phase 1/Phase 2
Status: Withdrawn
Sponsored by: La Jolla Pharmaceutical Company Official(s) and/or principal investigator(s): Lauren Pinter-Brown, MD, Principal Investigator, Affiliation: UCLA, Division of Hematology/Oncology
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.
Clinical Details
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 design: Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: 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: 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
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unpublished data; Finbarr Cotter et al, Annals of Oncology, vol 16, 205, Suppl 5.)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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
UCLA Medical Center, Los Angeles, California 90095, United States
Additional Information
Starting date: July 2008
Last updated: June 21, 2013
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