NCT00042822

Brief 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2002

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 5, 2002

Completed
6 months until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2005

Completed
Last Updated

May 17, 2011

Status Verified

December 1, 2009

Enrollment Period

2.8 years

First QC Date

August 5, 2002

Last Update Submit

May 14, 2011

Conditions

LeukemiaLymphomaMyelodysplastic SyndromesMyelodysplastic/Myeloproliferative Neoplasms

Keywords

recurrent adult acute myeloid leukemiarefractory anemia with excess blastsrefractory anemia with excess blasts in transformationchronic myelomonocytic leukemiarecurrent grade 3 follicular lymphomapreviously treated myelodysplastic syndromessecondary myelodysplastic syndromesuntreated adult acute myeloid leukemiarecurrent grade 1 follicular lymphomarecurrent grade 2 follicular lymphomarecurrent adult diffuse large cell lymphomarecurrent adult diffuse mixed cell lymphomarecurrent adult diffuse small cleaved cell lymphomaatypical chronic myeloid leukemia, BCR-ABL1 negativemyelodysplastic/myeloproliferative neoplasm, unclassifiableadult acute myeloid leukemia with t(8;21)(q22;q22)adult acute myeloid leukemia with t(16;16)(p13;q22)adult acute myeloid leukemia with inv(16)(p13;q22)adult acute myeloid leukemia with 11q23 (MLL) abnormalitiesadult acute myeloid leukemia with t(15;17)(q22;q12)

Interventions

romidepsinDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

Related Publications (1)

  • Klimek VM, Fircanis S, Maslak P, Guernah I, Baum M, Wu N, Panageas K, Wright JJ, Pandolfi PP, Nimer SD. Tolerability, pharmacodynamics, and pharmacokinetics studies of depsipeptide (romidepsin) in patients with acute myelogenous leukemia or advanced myelodysplastic syndromes. Clin Cancer Res. 2008 Feb 1;14(3):826-32. doi: 10.1158/1078-0432.CCR-07-0318.

    PMID: 18245545RESULT

MeSH Terms

Conditions

LeukemiaLymphomaMyelodysplastic SyndromesMyelodysplastic-Myeloproliferative DiseasesLeukemia, Myeloid, AcuteAnemia, Refractory, with Excess of BlastsLeukemia, Myelomonocytic, ChronicLymphoma, FollicularLymphoma, Large B-Cell, DiffuseLymphoma, Non-HodgkinLeukemia, Myeloid, Chronic, Atypical, BCR-ABL NegativeMyeloproliferative DisordersCongenital Abnormalities

Interventions

romidepsin

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesBone Marrow DiseasesLeukemia, MyeloidAnemia, RefractoryAnemiaChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsLymphoma, B-CellCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Virginia Klimek, MD

    Memorial Sloan Kettering Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 5, 2002

First Posted

January 27, 2003

Study Start

May 1, 2002

Primary Completion

March 1, 2005

Last Updated

May 17, 2011

Record last verified: 2009-12

Locations

US(1)