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Phase 1/2 Study of GCS-100 in Combination With Etoposide and Dexamethasone in Relapsed or Refractory Diffuse Large B Cell Lymphoma


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Diffuse Large B-cell Lymphoma

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Trial Information

Phase 1/2 Study of GCS-100 in Combination With Etoposide and Dexamethasone in Relapsed or Refractory Diffuse Large B Cell Lymphoma


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unpublished data; Finbarr Cotter et al, Annals of Oncology, vol 16, 205, Suppl 5.)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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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.

Outcome Time Frame:

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

Safety Issue:

Yes

Principal Investigator

Lauren Pinter-Brown, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UCLA, Division of Hematology/Oncology

Authority:

United States: Food and Drug Administration

Study ID:

PR-CS010

NCT ID:

NCT00776802

Start Date:

July 2008

Completion Date:

April 2009

Related Keywords:

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

Name

Location

UCLA Medical Center Los Angeles, California  90095-7059