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

NCT00776802 | Withdrawn Phase 1

• 1 other identifier: PR-CS010
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Diffuse Large B-cell Lymphoma

Keywords

GCS-100; Diffuse Large B-cell Lymphoma; DLBCL; Relapsed or refractory DLBCL; Etoposide; Dexamethasone

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (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

  Baseline, Day 1, and Day 5 laboratory assessments

Study Arms (1)

GCS-10

EXPERIMENTAL

Drug: GCS-100; Drug: Etoposide; Dexamethasone

Interventions

GCS-100 DRUG

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

GCS-10

Etoposide; Dexamethasone DRUG

Etoposide 100 mg/m2 on Study Days 3, 4 and 5; Dexamethasone 10 mg/m2 on Study Days 1, 2, 3, 4 and 5.

Also known as: Eposin, VP-16, Etopophos, Vepesid, Decadron

GCS-10

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• La Jolla Pharmaceutical Company: lead

Study Sites (1)

UCLA Medical Center

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse; Recurrence

Interventions

GCS-100; Etoposide; Dexamethasone; etoposide phosphate; Calcium Dobesilate

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Steroids, Fluorinated; Benzenesulfonates; Benzene Derivatives; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Study Officials

• Lauren Pinter-Brown, MD

  UCLA, Division of Hematology/Oncology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2008
• First Posted: October 21, 2008
• Study Start: July 1, 2008
• Primary Completion: April 1, 2009
• Study Completion: April 1, 2009
• Last Updated: June 25, 2013

Record last verified: 2013-06

Locations

US (1)