A Phase II Study Of The Farnesyltransferase Inhibitor ZANESTRA (R115777, NSC #702818, IND #58,359) In Complete Remission Following Induction And/Or Consolidation Chemotherapy In Adults With Poor-Risk Acute Myelogenous Leukemia (AML) And High-Risk Myelodysplasia (MDS)
Completed · Phase 2
Conditions studied: Adult Acute Myeloid Leukemia in Remission, Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities, Adult Acute Myeloid Leukemia With Del(5q), Adult Acute Myeloid Leukemia With Inv(16)(p13;q22), Adult Acute Myeloid Leukemia With t(15;17)(q22;q12), Adult Acute Myeloid Leukemia With t(16;16)(p13;q22), Adult Acute Myeloid Leukemia With t(8;21)(q22;q22), de Novo Myelodysplastic Syndromes, Secondary Myelodysplastic Syndromes
In brief
Tipifarnib may stop the growth of cancer cells by blocking the enzymes necessary for their growth. Phase II trial to study the effectiveness of tipifarnib in treating patients who have acute myeloid leukemia or myelodysplastic syndrome in first complete remission
Key facts
- Study ID
- NCT00045396
- Run by
- National Cancer Institute (NCI)
- People needed
- 44
- Starts
- 2002-06-01
- Last updated by the study team
- 2013-01-09
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Pathological Confirmation of the Diagnosis of AML, MDS
- PMNs >= 1,000/ul
- Platelets >= 30,000/ul
- Hematocrit >= 27% and/or Hemoglobin >= 9 gm/dl unsupported
- ECOG Performance Status 0-2
- Patients must be able to give informed consent
- Female patients of childbearing age must have negative pregnancy test
- AST, ALT and Alkaline Phosphatase =<2.5 x normal
- Bilirubin =< 1.5 x normal
- Serum Creatinine =< 2.0 mg/dl or Creatinine Clearance >= 40 ml/min
- Left Ventricular Ejection Fraction >= 25%
- Patients with poor-risk AML or high-risk MDS who have completed both induction and consolidation chemotherapy; poor risk AML is defined by one or more of the following characteristics:
- Antecedent Hematologic Disorder
- AML Arising from MDS
- Therapy-related AML
- Age >= 60 (in absence of favorable cytogenetics)
- Adverse Cytogenetics (i.e., -5/5q, -7/7q, +8, 20q-, 11q23 abnormalities, complex karyotype; other abnormalities may be considered at discression of study chair)
- Hyperleukocytosis at diagnosis (Blasts >= 30,000/mm\^3 at diagnosis in absence of favorable cytogenetics)
- High Risk MDS is defined by one or more of the following characteristics:
- RAEB and RAEB-t, with IPSS Score >= 1.5 (adverse cytogenetics, > 10% marrow blasts, cytopenias in at least 2 lineages): See Appendix E (Greenberg, et al. Blood 89:2079-2088,1997)36
- CMML with > 5% marrow blasts
- Therapy-related MDS
You may not qualify if…
- Any previous treatment with ZARNESTRA
- Ongoing participation in any Phase II or III clinical trial where DFS and OS are primary endpoints (unless patient is withdrawn from that trial)
- Acute promyelocytic (FAB M3) subtype
- Presence of (8;21) translocation or inversion 16 genotype as sole abnormality
- Eligible for curative allogeneic stem cell transplantation
- Known allergy to imidazole drugs (e.g., ketoconazole, miconazole)
- Presence of Residual AML (> 5% marrow blasts) or MDS, as Determined by Morphology, Flow Cytometry, and/or Cytogenetics
- Active, Uncontrolled Infection
- Disseminated Intravascular Coagulation
- Active CNS Leukemia
- Concomitant Chemotherapy, Radiation Therapy or Immunotherapy
- Women who are pregnant or lactating will not be eligible for this trial, as the investigational agent may be harmful to the developing fetus or nursing infant
Where it is running
- Johns Hopkins University — Baltimore, Maryland, United States
Full record on ClinicalTrials.gov
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