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

NCT ID: NCT00077194

Last Updated: 2013-02-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-01-31

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.

Detailed Description

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.

Conditions

Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm I

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.

Group Type: EXPERIMENTAL

romidepsin

Intervention Type: DRUG

Interventions

romidepsin

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nancy L. Bartlett, MD

Role: STUDY_CHAIR

Washington University Siteman Cancer Center

Locations

Howard University Cancer Center at Howard University Hospital

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

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, United States

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, United States

University of Wisconsin Comprehensive Cancer Center

Madison, Wisconsin, United States

Countries

United States

Other Identifiers

MAYO-MC0287

Identifier Type: -

Identifier Source: secondary_id

NCI-5961

Identifier Type: -

Identifier Source: secondary_id

CDR0000349660

Identifier Type: REGISTRY

Identifier Source: secondary_id

NCI-2012-02571

Identifier Type: -

Identifier Source: org_study_id