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Home > "F" Clinical Trials Conditions > FR901228 in Treating Patients With Hematologic Cancer  FR901228 in Treating Patients With Hematologic Cancer
FR901228 in Treating Patients With Hematologic Cancer
For Condition: refractory chronic lymphocytic leukemia,Waldenstrom's Macroglobulinemia,recurrent adult acute lymphoblastic leukemia,untreated adult acute lymphoblastic leukemia,recurrent adult acute myeloid leukemia,untreated adult acute myeloid leukemia,recurrent diffuse small lymphocytic/marginal zone lymphoma
Status: No longer recruiting
Sponsor(s): Arthur G. James Cancer Hospital & Richard J. Solove Research Institute , National Cancer Institute (NCI)
Synopsis: 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.
Details: OBJECTIVES: - Determine the in vivo biologic effect of FR901228 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 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:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
GuidoMarcucci, Study Chair, Arthur G. James Cancer Hospital & Richard J. Solove Research Institute
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, 43210-1240
United States
Additional Information:
Study ID Numbers: CDR0000068898; NCI-27,OSU-00H0350
Study Start Date:
Record last reviewed: March 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00024180
Other Recurrent Adult Acute Lymphoblastic Leukemia Studies:
1. Combination Chemotherapy in Treating Patients With Chronic Myelogenous Leukemia or Recurrent Acute Leukemia
2. Fludarabine and Total-Body Irradiation Followed By Donor Peripheral Stem Cell Transplantation in Treating Patients With Acute Lymphoblastic Leukemia or Chronic Myelogenous Leukemia That Has Responded to Treatment With Imatinib Mesylate
3. Monoclonal Antibody Therapy in Treating Patients With Recurrent Acute Lymphoblastic Leukemia or Non-Hodgkin's Lymphoma
4. 506U78 in Treating Patients With Refractory or Relapsed Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma
5. STI571 Plus Combination Chemotherapy in Treating Patients With Chronic Myelogenous Leukemia or Acute Lymphocytic Leukemia
Related Studies:
Other recurrent adult acute lymphoblastic leukemia Clinical Trials
Other Ohio Clinical Trials
Other Columbus Clinical Trials
FR901228 in Treating Patients With Hematologic Cancer
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