NCT00024180

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of FR901228 in treating patients who have hematologic cancer.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Jan 2002

Typical duration for phase_1 leukemia

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 13, 2001

Completed
4 months until next milestone

Study Start

First participant enrolled

January 1, 2002

Completed
1.1 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
3.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2006

Completed
Last Updated

January 31, 2013

Status Verified

November 1, 2002

First QC Date

September 13, 2001

Last Update Submit

January 30, 2013

Conditions

LeukemiaLymphoma

Keywords

Waldenström macroglobulinemiarecurrent adult acute myeloid leukemiarecurrent adult acute lymphoblastic leukemiarefractory chronic lymphocytic leukemiauntreated adult acute lymphoblastic leukemiauntreated adult acute myeloid leukemiarecurrent small lymphocytic lymphoma

Interventions

romidepsinDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Diagnosis of one of the following hematologic malignancies: * Chronic lymphocytic leukemia (CLL) * Small lymphocytic lymphoma (SLL) (including Waldenstrom's macroglobulinemia) * Acute myeloid leukemia (AML) * Acute lymphoblastic leukemia (ALL) * Stratum I (CLL and SLL): * Received at least one prior therapy containing a purine analog OR * Received another form of therapy (including alkylating agents) due to history of severe autoimmune disease, requirement for chronic corticosteroid, or other contraindication to purine analog therapy * Stratum II (AML and ALL): * Primary refractory or relapsed leukemia within the past year that is not amenable to curative therapy * OR * Untreated or previously treated poor-risk leukemia defined by any of the following: * 65 years of age and over * Poor-risk candidates for aggressive chemotherapy * Poor-risk cytogenetics (for AML, karyotype abnormalities other than t(8;21), inv(16), t(15;17)) PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-2 Life expectancy: * At least 12 weeks Hematopoietic: * Stratum I only: * No uncontrolled autoimmune hemolytic anemia * No idiopathic thrombocytopenic purpura * Stratum II only: * WBC no greater than 10,000/mm\^3 OR * WBC no greater than 40,000/mm\^3 that is stable for at least 1 week (may be sustained by hydroxyurea through the first week of study) Hepatic: * Bilirubin no greater than 1.5 mg/dL * ALT and AST no greater than 3 times upper limit of normal Renal: * Creatinine less than 2.0 mg/dL Cardiovascular: * Ejection fraction at least 50% by MUGA * No myocardial infarction or unstable angina within the past 6 months * No prior unstable ventricular or supraventricular cardiac arrhythmias Other: * HIV negative * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No other medical or psychiatric problem that would preclude study * Stratum I only: * No active infection requiring oral or IV antibiotics PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * See Disease Characteristics * At least 28 days since prior chemotherapy (except hydroxyurea) * At least 6 weeks since prior nitrosoureas * At least 8 weeks since prior UCN-01 (unless plasma UCN-01 level less than 1 uM) Endocrine therapy: * See Disease Characteristics Radiotherapy: * At least 28 days since prior radiotherapy Surgery: * At least 28 days since prior major surgery

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

Sponsors & Collaborators

Study Sites (1)

Arthur G. James Cancer Hospital - Ohio State University

Columbus, Ohio, 43210-1240, United States

Location

Related Publications (1)

  • Byrd JC, Marcucci G, Parthun MR, Xiao JJ, Klisovic RB, Moran M, Lin TS, Liu S, Sklenar AR, Davis ME, Lucas DM, Fischer B, Shank R, Tejaswi SL, Binkley P, Wright J, Chan KK, Grever MR. A phase 1 and pharmacodynamic study of depsipeptide (FK228) in chronic lymphocytic leukemia and acute myeloid leukemia. Blood. 2005 Feb 1;105(3):959-67. doi: 10.1182/blood-2004-05-1693. Epub 2004 Oct 5.

    PMID: 15466934RESULT

MeSH Terms

Conditions

LeukemiaLymphomaWaldenstrom MacroglobulinemiaLeukemia, Myeloid, AcutePrecursor Cell Lymphoblastic Leukemia-LymphomaLeukemia, Lymphocytic, Chronic, B-Cell

Interventions

romidepsin

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesNeoplasms, Plasma CellHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHemorrhagic DisordersLeukemia, MyeloidLeukemia, LymphoidLeukemia, B-CellChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Guido Marcucci, MD

    Ohio State University Comprehensive Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2001

First Posted

January 27, 2003

Study Start

January 1, 2002

Study Completion

August 1, 2006

Last Updated

January 31, 2013

Record last verified: 2002-11

Locations

US(1)