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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Histone Deacetylase Inhibitors; Romidepsin

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