NCT00077194

Brief Summary

This phase II trial is studying how well FR901228 works in treating patients with relapsed or refractory non-Hodgkin's lymphoma. Drugs used in chemotherapy, such as FR901228, work in different ways to stop tumor cells from dividing so they stop growing or die.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at P25-P50 for phase_2 lymphoma

Geographic Reach
1 country

4 active sites

Status
completed

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

January 1, 2004

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 10, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 11, 2004

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2005

Completed
Last Updated

February 11, 2013

Status Verified

February 1, 2005

Enrollment Period

1.9 years

First QC Date

February 10, 2004

Last Update Submit

February 8, 2013

Conditions

Lymphoma

Keywords

recurrent adult diffuse large cell lymphomarecurrent mantle cell lymphomarecurrent adult Burkitt lymphoma

Study Arms (1)

Arm I

EXPERIMENTAL

Patients receive FR901228 (depsipeptide) IV over 4 hours on days 1, 8, and 15. Treatment repeats every 28 days for at least 6 courses in the absence of disease progression or unacceptable toxicity.

Drug: romidepsin

Interventions

romidepsinDRUG
Arm I

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed aggressive B-cell non-Hodgkin's lymphoma of 1 of the following cellular types: * Diffuse large cell * Mantle cell * Burkitt's * Relapsed or refractory disease * No more than 2 prior regimen for patients with refractory disease * Any number of prior therapies (including peripheral blood stem cell or bone marrow transplantation) allowed for patients with relapsed disease provided there was an objective response to the most recent therapy * Measurable disease * At least 1 lesion ≥ 1.5 cm in diameter * No transformed lymphoma * No CNS lymphoma * Ineligible for, refused, or relapsed after stem cell transplantation PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-2 Hematopoietic * Absolute neutrophil count ≥ 1,000/mm\^3 (500/mm\^3 in patients with extensive bone marrow involvement \[\> 50%\] or hypersplenism with palpable splenomegaly) * Platelet count ≥ 75,000/mm\^3 (50,000/mm\^3 in patients with extensive bone marrow involvement or hypersplenism with palpable splenomegaly) Hepatic * Bilirubin ≤ upper limit of normal (ULN) * Alkaline phosphatase ≤ 2 times ULN * AST ≤ 2 times ULN Renal * Creatinine ≤ ULN Cardiovascular * QTc \< 500 msec by ECG * Cardiac function ≥ 50% by MUGA * No prior serious ventricular arrhythmia * No New York Heart Association class III or IV congestive heart failure * No significant cardiac hypertrophy by ECG * No other significant cardiac disease Pulmonary * No chronic obstructive pulmonary disease Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * HIV negative * No active infection * No diabetes * No other uncontrolled serious medical condition PRIOR CONCURRENT THERAPY: Chemotherapy * Prior cumulative doxorubicin dose \< 450 mg/m\^2 * Prior cumulative mitoxantrone dose \< 112 mg/m\^2 * Prior doxorubicin equivalent dose \< 450 mg/m\^2 (for patients who have previously received both doxorubicin and mitoxantrone) Other * Recovered from all prior therapy * No prior histone deacetylase inhibitor therapy * No concurrent medication associated with QTc prolongation, such as dolasetron * Concurrent hydrochlorothiazide, furosemide, or other diuretics allowed provided patient is on concurrent potassium chloride supplementation

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (4)

Howard University Cancer Center at Howard University Hospital

Washington D.C., District of Columbia, 20060, United States

Location

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231, United States

Location

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201-1379, United States

Location

University of Wisconsin Comprehensive Cancer Center

Madison, Wisconsin, 53792-5256, United States

Location

MeSH Terms

Conditions

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

Interventions

romidepsin

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLymphoma, B-CellLymphoma, Non-HodgkinEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus Infections

Study Officials

  • Nancy L. Bartlett, MD

    Washington University Siteman Cancer Center

    STUDY CHAIR

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

February 10, 2004

First Posted

February 11, 2004

Study Start

January 1, 2004

Primary Completion

December 1, 2005

Last Updated

February 11, 2013

Record last verified: 2005-02

Locations

US(4)