Non Hodgkin Lymphoma Clinical Trial

FR901228 in Treating Patients With Myelodysplastic Syndrome, Acute Myeloid Leukemia, or Non-Hodgkin’s Lymphoma

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of FR901228 in treating patients who have myelodysplastic syndrome, acute myeloid leukemia, or non-Hodgkin's lymphoma.

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Full Description

OBJECTIVES:

Determine the pattern of adverse clinical experience in patients with myelodysplastic syndrome, acute myeloid leukemia, or intermediate-grade or follicular non-Hodgkin's lymphoma treated with FR901228 (depsipeptide).
Determine the disease response in patients treated with this drug.
Determine the pharmacokinetic and pharmacodynamic correlates of this drug, including measurement of serum plasma levels, H3 and H4 acetylation, apoptosis induction, differentiation, and multidrug-resistant (MDR) phenotype expression in these patients.

OUTLINE: Patients receive FR901228 (depsipeptide) IV over 4 hours on days 1 and 5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Patients are followed monthly.

PROJECTED ACCRUAL: A total of 12 patients will be accrued for this study within 1 year.

View Eligibility Criteria

Eligibility Criteria

DISEASE CHARACTERISTICS:

One of the following diagnoses:

Histologically confirmed refractory or relapsed acute myeloid leukemia (AML)

Failed anthracycline-based chemotherapy
Ineligible for or refused allogeneic stem cell transplantation

Elderly patients with newly diagnosed AML

Ineligible for or refused standard chemotherapy

Histologically confirmed high-risk myelodysplastic syndromes

Eligible subtypes include:

Refractory anemia with excess blasts (RAEB)
RAEB in transformation
Chronic myelomonocytic leukemia
Ineligible for or refused allogeneic bone marrow transplantation

Histologically confirmed intermediate-grade non-Hodgkin's lymphoma (NHL)

Relapsed after high-dose therapy OR
Ineligible for allogeneic or autologous stem cell transplantation
Evaluable lesions by radiologic study or physical examination

Histologically confirmed follicular NHL

Progressed after anthracycline-based chemotherapy and rituximab
Evaluable lesions by radiologic study or physical examination NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology.

PATIENT CHARACTERISTICS:

Age

18 and over

Performance status

Karnofsky 60-100%

Life expectancy

Not specified

Hematopoietic

Not specified

Hepatic

Bilirubin no greater than 1.5 mg/dL (unless due to Gilbert's syndrome)
SGOT and SGPT less than 2 times upper limit of normal

Renal

Creatinine no greater than 1.5 mg/dL OR
Creatinine clearance at least 60 mL/min

Cardiovascular

Cardiac ejection fraction greater than 50%
No cardiac hypertrophy
No known conduction heart disease
No New York Heart Association class III or IV heart disease that would make it difficult to assess patient during study participation
No significant prior heart disease
No significant prior secondary or tertiary heart block
No significant prior atrial or ventricular arrhythmia requiring therapeutic intervention or antiarrhythmics for rate control

Pulmonary

No severe debilitating pulmonary disease that would make it difficult to assess patient during study participation

Other

Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception during and for 1 month after study participation
Potassium ≥ 4.0 mmol/L (supplementation allowed)
Magnesium ≥ 2.0 mg/dL (supplementation allowed)
No other concurrent active malignancy except basal cell skin cancer
No other concurrent significant co-morbidity that would make it difficult to assess patient during study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

See Disease Characteristics
At least 2 weeks since prior epoetin alfa or filgrastim (G-CSF)
At least 4 weeks since prior cytokines
No concurrent immunotherapy

Chemotherapy

See Disease Characteristics
At least 4 weeks since prior systemic chemotherapy
No other concurrent chemotherapy

Endocrine therapy

Not specified

Radiotherapy

At least 4 weeks since prior radiotherapy
No concurrent radiotherapy

Surgery

Not specified

Other

No other concurrent investigational agents

No concurrent drugs that may prolong the QTc interval

FR901228 (depsipeptide) may be administered after a 5-half-life washout period following the use of these drugs

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 2

Study ID:

NCT00042822

Recruitment Status:

Completed

Sponsor:

Memorial Sloan Kettering Cancer Center

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There is 1 Location for this study

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Memorial Sloan-Kettering Cancer Center
New York New York, 10021, United States

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 2

Study ID:

NCT00042822

Recruitment Status:

Completed

Sponsor:


Memorial Sloan Kettering Cancer Center

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