A Single Agent Phase II Study of Depsipeptide (FK228) in the Treatment of Cutaneous T-cell Lymphoma
Responses were evaluated according to a composite assessment (Objective Primary Disease
Response Evaluation Criteria [OPDREC]) that included cutaneous manifestations of disease,
lymph node involvement, and circulating malignant T-cells (Sézary cells). Skin involvement
was measured using a weighted body surface area skin assessment tool (WBSA/SWAT) or an
erythroderma score, depending upon the pt's disease. Disease response was assessed by the
Investigators and an Independent Response Review Committee (IRRC) with the IRRC assessment
considered supportive of the Investigator's evaluations using the following criteria:
Complete Response (CR):
- Complete resolution of skin patches, skin plaques, and skin tumors, or erythroderma
- No evidence of abnormal lymph nodes
- Absence of circulating Sézary cells.
- No evidence of new tumors (cutaneous or non-cutaneous)
- Findings confirmed by skin biopsy
Clinical complete response (CCR):
- Same as CR but without skin biopsy
Partial Response (PR):
- ≥50% improvement in the summation of (change in Skin + change in Lymph Node + change in
Peripheral Blood) with
- At least >30% improvement in Skin and
- No worsening in Lymph Node or Sézary cells.
- No evidence of new tumors (cutaneous/non-cutaneous)
Stable Disease (SD):
- Not enough improvement or worsening in the summation of (change in Skin + change in
Lymph Node + change in Peripheral Blood to qualify as PR or PD
- No evidence of new tumors (cutaneous/non-cutaneous)
SD90:
- SD90 was defined as documented evidence of SD for at least 90 Days Duration
Progressive Disease (PD):
- Evidence of new tumor (cutaneous or non-cutaneous), OR
- >25% worsening in the summation of (change in Skin + change in Lymph Node + change in
Peripheral Blood) with >15% worsening in change in Skin.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
The Percent of Patients (Pts) With Objective Disease Response
The percent of pts with confirmed Objective Disease Response (confirmed best responses of complete response [CR], clinical complete response [CCR], or partial response [PR]). Responses were evaluated according to a composite assessment (Objective Primary Disease Response Evaluation Criteria - OPDREC).
6 months
No
Jean Nichols, Ph.D.
Study Director
Gloucester Pharmaceuticals, Inc.
United States: Food and Drug Administration
GPI-04-0001
NCT00106431
January 2005
December 2008
Name | Location |
---|---|
MD Anderson Cancer Center | Houston, Texas 77030-4096 |
Vanderbilt-Ingram Cancer Center | Nashville, Tennessee 37232-6838 |
Boston Medical Center | Boston, Massachusetts 02118 |
UCLA Jonsson Cancer Center | Los Angeles, California 90095 |
Stanford Comprehensive Cancer Center | Stanford, California 94305 |
University of Pennsylvania Abrahamson Cancer Center | Philadelphia, Pennsylvania 19104 |