Expired Study
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Columbus, Ohio 43210


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.


Study summary:

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.


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


NCT ID:

NCT00024180


Primary Contact:

Study Chair
Guido Marcucci, MD
Ohio State University Comprehensive Cancer Center


Backup Contact:

N/A


Location Contact:

Columbus, Ohio 43210
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: September 24, 2017

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