NCT00383565

Brief Summary

FR901228 may stop the growth of cancer cells by blocking some of the enzymes needed for cell to grow and by blocking blood flow to the cancer. This phase II trial is studying how well FR901228 works in treating patients with relapsed or refractory non-Hodgkin's lymphoma.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Sep 2006

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2006

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

September 29, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 3, 2006

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

August 22, 2012

Completed
Last Updated

May 20, 2014

Status Verified

April 1, 2013

Enrollment Period

4.6 years

First QC Date

September 29, 2006

Results QC Date

July 19, 2012

Last Update Submit

May 2, 2014

Conditions

Recurrent Adult Diffuse Large Cell LymphomaRecurrent Mantle Cell Lymphoma

Outcome Measures

Primary Outcomes (1)

  • Overall Objective Response Rate (Complete Response [CR] and Partial Response [PR]) After 6 Courses of Treatment

    International Working Group response for non- Hodgkin's lymphoma: Complete Response (CR) - disappearance all detectable clinical/radiographic evidence of disease and disappearance of all disease-related symptoms (present before therapy) and normalization of those biochemical abnormalities; Partial Response (PR) - ≥50% decrease in sum products of greatest diameters (SPD) of 6 largest dominant nodes or nodal masses, selected by clearly measurable in at least two perpendicular dimensions, from disparate regions of body and no decrease in size of other nodes, liver, or spleen.

    24 weeks (6 courses of 4 week cycles)

Secondary Outcomes (2)

  • Median Progression Free-survival (PFS)

    2 Years

  • Median Overall Survival

    5 Years

Study Arms (1)

Arm I

EXPERIMENTAL

Patients receive FR901228 IV over 4 hours on days 1, 8, and 15.

Drug: romidepsin

Interventions

romidepsinDRUG

Given IV

Also known as: FK228, FR901228, Istodax
Arm I

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically confirmed aggressive B-cell non-Hodgkin's lymphoma of 1 of the following subtypes:
  • Mantle cell lymphoma
  • Diffuse large cell lymphoma
  • (Ineligible for or unwilling to undergo stem cell transplantation)
  • Relapsed or refractory disease:
  • Any number of prior therapies allowed for relapsed disease, including peripheral blood stem cell or bone marrow transplantation
  • No more than 2 prior regimens, excluding monotherapy with monoclonal antibody or radiotherapy, for refractory disease
  • Measurable disease, defined as \>= 1 lesion \>= 1.5 cm in the longest diameter
  • No transformed lymphoma, defined as the transformation of a low-grade lymphoma, including follicular lymphoma or small lymphocytic lymphoma, to a high-grade lymphoma (e.g., diffuse large cell lymphoma)
  • ECOG performance status 0-2
  • Absolute neutrophil count \>= 1,000/mm\^3 OR \>= 500/mm\^3 if extensive bone marrow involvement (\> 50%) or hypersplenism with palpable splenomegaly
  • Platelet count \>= 75,000/mm\^3 OR \>= 50,000/mm\^3 if extensive bone marrow involvement (\> 50%) or hypersplenism with palpable splenomegaly
  • Bilirubin normal
  • Alkaline phosphatase =\< 2 times upper limit of normal (ULN)
  • AST =\< 2 times ULN
  • +18 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Lymphoma, Large B-Cell, DiffuseLymphoma, Mantle-Cell

Interventions

romidepsin

Condition Hierarchy (Ancestors)

Lymphoma, B-CellLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Results Point of Contact

Title
Dr. Luis E. Fayad / Associate Professor
Organization
MD Anderson Cancer Center
jmdennison@mdanderson.org
713-792-2860

Study Officials

  • Jorge Romaguera

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 29, 2006

First Posted

October 3, 2006

Study Start

September 1, 2006

Primary Completion

April 1, 2011

Study Completion

April 1, 2011

Last Updated

May 20, 2014

Results First Posted

August 22, 2012

Record last verified: 2013-04

Locations

US(1)