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FR901228 in Treating Patients With Hematologic Cancer - Article


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Waldenström's Macroglobulinemia


Clinical Trial: FR901228 in Treating Patients With Hematologic Cancer

This study is no longer recruiting patients.

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

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 Treatment or Intervention Phase
Waldenstrom's 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 diffuse small lymphocytic/marginal zone lymphoma
 Drug: FR901228
 Procedure: chemotherapy
Phase I

MedlinePlus related topics:  Blood and Blood Disorders;   Bone Marrow Diseases;   Immune System and Disorders;   Leukemia, Adult Acute;   Leukemia, Adult Chronic;   Leukemia, Childhood;   Lymphatic Diseases;   Lymphoma;   Vascular Diseases

Study Type: Interventional
Study Design: Treatment

Official Title: Phase I Study of FR901228 (Depsipeptide) in Patients With Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, Acute Myeloid Leukemia, or Acute Lymphoblastic Leukemia

Further Study Details: 

OBJECTIVES:

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 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 above,  Genders Eligible for Study:  Both

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 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

Location Information


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

Study chairs or principal investigators

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

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000068898; OSU-00H0350; NCI-27
Record last reviewed:  March 2003
Last Updated:  October 13, 2004
Record first received:  September 13, 2001
ClinicalTrials.gov Identifier:  NCT00024180
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005


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October 10, 2008



Page Updated: September 23, 2004
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