SWOG clinical trial number
S0432
Phase II Studies of Two Different Schedules and Two Different Doses of the Farnesyl Transferase Inhibitor R115777 (Tipifarnib, Zarnestra�, NSC-702818)for Previously Untreated Acute Myeloid Leukemia (AML) in Patients of Age 70 or Older.
Closed
Phase
Accrual
100%
Published
Research committees
Leukemia
Treatment
R115777
Eligibility Criteria Expand/Collapse
Pts must have a morphologically confirmed diagnosis of AML with classification other than WHO Acute Promyelocytic Leukemia (FAB M3), based on bone marrow aspiration and biopsy performed within 14 days prior to registration. If a diagnostic biopsy has been performed within 28 days prior to registration, the marrow blast percentage is >/= 70%, and no potentially anti-leukemic therapy has been given in the interim, then this bone marrow examination may be used for registration purposes. Pts with WHO Acute Promyelocytic Leukemia (FAB M3) or blastic transformation of CML are not eligible. Pts must not be candidates for or must have refused standard AML cytotoxic chemotherapy regimens. Pts must have reached their 70th birthday. Pts must not have received prior systemic chemotherapy for acute leukemia with the exception of hydroxyurea. Pts must have a WBC less than or equal to 30,000/cmm within 1 day prior to registration. Administration of hydroxyurea to control high WBC count prior to, during and after registration is permitted. Pts with a history of prior MDS are eligible. Pts must have a bilirubin less than or equal to 1.5 x IULN, unless the elevation is due primarily to elevated unconjugated hyperbilirubinemia secondary to Gilbert's syndrome or hemolysis and not to liver dysfunction. Pts should also have a SGOT (AST) less than or equal to 2.5 x IULN, or SGPT (ALT) less than or equal to 2.5 x IULN, or both within 14 days prior to registration. Pts must have a serum creatinine less than or equal to 1.5 x IULN within 14 days prior to registration. Southwest Oncology Group pts must be registered on SWOG-9007 and must be offered participation in S9910. Pts of reproductive potential must have agreed to use an effective contraceptive method. Pts with a prior malignancy are eligible. However, the pt must have completed all chemotherapy and radiotherapy at least 6 months prior to study registration. There should be no plan to begin therapy for the prior malignancy at the time of study registration. Concurrent hormonal therapy is allowed. Pts who are expected to require treatment with enzyme inducing anti-epileptic drugs (EIAED) are not eligible for this study.
Publication Information Expand/Collapse
2023
2019
2018
Comparable Outcomes of Patients Eligible versus Ineligible for SWOG Leukemia Studies
PMid: PMID29618479 | PMC number: PMC6014358
2014
PMid: PMID24411921 | PMC number: PMC4247790
2008
Phase II studies of different schedules and doses of the farnesyltransferase inhibitor tipifarnib (R11577, zarnestra) for patients age 70 or older with previously untreated acute myeloid leukemia (AML): North American Intergroup Study S0432.
2007
Phase II studies of different schedules and doses of the farnesyl transferase inhibitor tipifarnib (R115777, Zarnestra, NSC-702818) for patients of age 70 or older with previously untreated acute myeloid leukemia (AML): A North American Intergroup study (S0432)
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Research Committee(s)
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Open
Phase
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Research Committee(s)
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