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Home > "F" Clinical Trials Conditions > FR901228 in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia  FR901228 in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia
FR901228 in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia
For Condition: untreated adult acute myeloid leukemia,recurrent adult acute myeloid leukemia,adult acute promyelocytic leukemia (M3),secondary acute myeloid leukemia
Status: Recruiting
Sponsor(s): University of Chicago Cancer Research Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy, such as FR901228, work in different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of FR901228 in treating patients who have relapsed or refractoryacute myeloid leukemia.
Details: OBJECTIVES: - Determine the complete and partial response rate in patients with relapsed or refractory acute myeloid leukemia treated with FR901228. - Determine the toxicity of this drug in these patients. - Correlate clinical response with specific cytogenetic abnormalities in patients treated with this drug. OUTLINE: This is a multicenter study. Patients are stratified according to the presence of a specific chromosomal abnormality (t[8;21] vs inv 16 vs t[15;17] vs absence of these chromosomal abnormalities). Patients receive FR901228 IV over 4 hours on days 1, 8, and 15. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: A total of 22-47 patients will be accrued for this study within 12-27 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed acute myeloid leukemia (AML) defined by the WHO classification - Initial diagnosis with either of the following: - Bone marrow or peripheral blood myeloblasts of at least 20% - Recurring genetic abnormalities (e.g., t[8;21], inv 16, or t[16;16]) and bone marrow blast percentage less than 20% - Relapsed or refractory disease defined by 1 of the following: - Under 60 years of age and in second relapse or greater - Over 60 years of age and in first relapse - Patients who are over 60 years of age with previously untreated disease and who refuse conventional chemotherapy are eligible - Patients who are over 60 years of age and in first relapse and poor medical candidates for reinduction chemotherapy or who refuse conventional chemotherapy are eligible - Acute promyelocytic leukemia that has relapsed despite prior tretinoin and arsenic therapy - Primary refractory AML for which no standard therapy exists - Not medically appropriate for OR refused curative bone marrow or stem cell transplantation - No CNS leukemia PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-2 OR - Karnofsky 60-100% Life expectancy - Not specified Hematopoietic - Not specified Hepatic - Bilirubin no greater than 2 times upper limit of normal (ULN) - AST/ALT no greater than 3 times ULN Renal - Creatinine no greater than 2 times ULN Cardiovascular - LVEF at least 40% by MUGA - QTc interval less than 500 msec by EKG - No myocardial infarction within the past 3 months - No symptomatic congestive heart failure - No unstable angina pectoris - No cardiac arrhythmia Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No prior allergic reactions attributed to compounds of similar chemical or biological composition to FR901228 - No concurrent uncontrolled illness - No ongoing or active infection - No psychiatric illness or social situation that would preclude study compliance PRIOR CONCURRENT THERAPY: Biologic therapy - See Disease Characteristics - At least 4 weeks since prior autologous stem cell or bone marrow transplantation - No prior allogeneic stem cell or bone marrow transplantation - No concurrent biologic agents Chemotherapy - See Disease Characteristics - At least 2 weeks since prior chemotherapy (6 weeks for mitomycin and nitrosoureas) - No prior FR901228 - No concurrent chemotherapy - Concurrent hydroxyurea allowed during the first course of study therapy to control hyperleukocytosis Endocrine therapy - Not specified Radiotherapy - At least 2 weeks since prior radiotherapy - No concurrent radiotherapy Surgery - Not specified Other - Recovered from prior therapy - At least 4 weeks since prior investigational agents - No concurrent combination antiretroviral therapy for HIV-positive patients - No other concurrent investigational agents - No concurrent drugs known to have histone deacetylase inhibitor activity (e.g., sodium valproate) - No other concurrent antineoplastic agents
Total Enrollment:
Location and Contact Information:
Overall Study Official:
OlatoyosiOdenike, Study Chair, University of Chicago Cancer Research Center
Vanderbilt University Medical Center *Recruiting*
Nashville, Tennessee, 37232
United States
Recruiting Stephen Brandt 615-936-7196
University of Chicago Cancer Research Center *Recruiting*
Chicago, Illinois, 60637
United States
Recruiting Olatoyosi Odenike 773-702-3354
Cardinal Bernardin Cancer Center at Loyola University Medical Center *Recruiting*
Maywood, Illinois, 60153
United States
Recruiting John Godwin 708-327-3300
Additional Information:
Study ID Numbers: CDR0000304460; NCI-5965,UCCRC-12209B
Study Start Date:
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00062075
Other Adult Acute Promyelocytic Leukemia (m3) Studies:
1. Donor Bone Marrow Transplantation in Treating Patients With Hematologic Cancer
2. Combination Chemotherapy Followed By Filgrastim or Sargramostim in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia or Acute Lymphoblastic Leukemia
3. GTI-2040 and High-Dose Cytarabine in Treating Patients With Refractory or Relapsed Acute Myeloid Leukemia
4. BMS-214662 in Treating Patients With Acute Leukemia, Myelodysplastic Syndrome, or Chronic Myeloid Leukemia
5. Phenylbutyrate, Dexamethasone, and Sargramostim in Treating Patients With Refractory or Relapsed Acute Myeloid Leukemia
Related Studies:
Other adult acute promyelocytic leukemia (M3) Clinical Trials
Other Tennessee Clinical Trials
Other Nashville Clinical Trials
FR901228 in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia
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