Non Hodgkin Lymphoma Clinical Trial

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

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.

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Full 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.

View Eligibility Criteria

Eligibility 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 is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 2

Estimated Enrollment:

35

Study ID:

NCT00077194

Recruitment Status:

Completed

Sponsor:

National Cancer Institute (NCI)

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There are 4 Locations for this study

See Locations Near You

Howard University Cancer Center at Howard University Hospital
Washington District of Columbia, 20060, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore Maryland, 21231, United States
Barbara Ann Karmanos Cancer Institute
Detroit Michigan, 48201, United States
University of Wisconsin Comprehensive Cancer Center
Madison Wisconsin, 53792, United States

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 2

Estimated Enrollment:

35

Study ID:

NCT00077194

Recruitment Status:

Completed

Sponsor:


National Cancer Institute (NCI)

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