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FR901228 in Treating Patients With Hematologic Cancer

This study has been completed.

Sponsors and Collaborators: Arthur G. James Cancer Hospital & Richard J. Solove Research Institute
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00024180
  Purpose

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.


Condition Intervention Phase
Leukemia
Lymphoma
Drug: romidepsin
Phase I

MedlinePlus related topics:   Cancer    Leukemia, Adult Acute    Leukemia, Adult Chronic    Lymphoma   

Drug Information available for:   FR 901228   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment
Official Title:   A Phase I Study of Depsipeptide in Selected Hematologic Malignancies (NSC 630176)

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:   January 2002

Detailed Description:

OBJECTIVES:

  • Determine the in vivo biologic effect of FR901228 (depsipeptide) in patients with chronic lymphocytic leukemia, small lymphocytic lymphoma, acute myeloid leukemia, or acute lymphoblastic leukemia.
  • Determine the pharmacokinetics and cellular pharmacodynamics of this drug in these patients.
  • Determine any preliminary anti-tumor activity of this drug in these patients.

OUTLINE: This is a dose-decreasing, multicenter study. Patients are stratified according to disease (chronic lymphocytic leukemia and small lymphocytic lymphoma vs acute myeloid leukemia and acute lymphoblastic leukemia).

Patients receive FR901228 (depsipeptide) IV over 4 hours on days 1, 8, and 15. Treatment repeats every 4 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity.

Cohorts of 10 patients per stratum receive decreasing doses of FR901228 until the minimal active dose is determined. If 5 or more patients show clinical or biological response, the subsequent cohort is treated at a lower dose. If fewer than 5 patients respond, the subsequent cohort is treated at a higher dose.

PROJECTED ACCRUAL: A minimum of 20 patients (10 per stratum) will be accrued for this study.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00024180

Locations
United States, Ohio
Arthur G. James Cancer Hospital - Ohio State University    
      Columbus, Ohio, United States, 43210-1240

Sponsors and Collaborators
Arthur G. James Cancer Hospital & Richard J. Solove Research Institute
National Cancer Institute (NCI)

Investigators
Study Chair:     Guido Marcucci, MD     Arthur G. James Cancer Hospital & Richard J. Solove Research Institute    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Publications of Results:

Study ID Numbers:   CDR0000068898, OSU-00H0350, NCI-27
First Received:   September 13, 2001
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00024180
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
Waldenstrom macroglobulinemia  
recurrent adult acute myeloid leukemia  
recurrent adult acute lymphoblastic leukemia  
refractory chronic lymphocytic leukemia  
untreated adult acute lymphoblastic leukemia
untreated adult acute myeloid leukemia
recurrent small lymphocytic lymphoma

Study placed in the following topic categories:
Chronic lymphocytic leukemia
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Immunoproliferative Disorders
Hematologic Neoplasms
Leukemia, B-cell, chronic
Acute myelogenous leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Recurrence
Acute lymphoblastic leukemia, adult
FR 901228
Leukemia
Lymphatic Diseases
Waldenstrom Macroglobulinemia
Waldenstrom macroglobulinemia
Acute myeloid leukemia, adult
Leukemia, B-Cell
Lymphoproliferative Disorders
Acute myelocytic leukemia
Lymphoma

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Immune System Diseases

ClinicalTrials.gov processed this record on December 03, 2008




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