Completed

FR901228 in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma

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What is being tested

romidepsin

Drug
Who is being recruted

Lymphoma

Over 18 Years
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: January 2004

Summary

Principal SponsorNational Cancer Institute (NCI)
Last updated: February 11, 2013
Sourced from a government-validated database.Claim as a partner
Study start date: January 1, 2004Actual date on which the first participant was enrolled.

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. OBJECTIVES: I. Determine the response rate (complete and partial) in patients with relapsed or refractory Burkitt's, mantle cell or diffuse large cell non-Hodgkin's lymphoma treated with FR901228 (depsipeptide). II. Determine the safety and feasibility of this drug, in terms of incidence and maximum grade of toxicity and courses delayed or doses reduced, in these patients. III. Determine the 2-year progression-free survival and overall survival of patients treated with this drug. IV. Correlate tumor expression of BCL-2, BCL-6, BAX, and RAS with response in patients treated with this drug. OUTLINE: This is a multicenter study. 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. Patients are followed every 3 months until disease progression and then every 6 months until 5 years from study registration.

Official TitleA Phase II Study Of Depsipeptide, A Histone Deacetylase Inhibitor, In Relapsed Or Refractory Mantle Cell Or Diffuse Large Cell Non-Hodgkin's Lymphoma 
Principal SponsorNational Cancer Institute (NCI)
Last updated: February 11, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
35 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, all participants receive the same treatment. Since there is only one group, there is no need for randomization or assignment to different arms. This type of study is often used to test a new treatment without comparing it to another.

Other Ways to Assign Participants
Randomized allocation
: Participants are assigned randomly, like flipping a coin, to ensure fairness and reduce bias.

Non-randomized allocation
: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.

How treatments are given to participants
In this study, all participants receive the same treatment. This approach is often used to evaluate the effects of a single intervention without comparing it to another.

Other Ways to Assign Treatments
Parallel assignment
: Participants are split into separate groups, each receiving a different treatment.

Cross-over assignment
: Participants switch between treatments during the study.

Factorial assignment
: Participants receive different combinations of treatments.

Sequential assignment
: Participants receive treatments one after another in a specific order, possibly based on individual responses.

Other assignment
: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled
: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind
: Participants do not know which treatment they are receiving, but researchers do.

Double-blind
: Neither participants nor researchers know which treatment is given.

Triple-blind
: Participants, researchers, and outcome assessors do not know which treatment is given.

Quadruple-blind
: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Lymphoma
Criteria

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


Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
One single intervention group 

is designated in this study

This study does not include a placebo group 

Treatment Groups
Group 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.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 4 locations
Suspended
Howard University Cancer Center at Howard University HospitalWashington, United StatesSee the location
Suspended
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, United States
Suspended
Barbara Ann Karmanos Cancer InstituteDetroit, United States
Suspended
University of Wisconsin Comprehensive Cancer CenterMadison, United States

Completed4 Study Centers