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)
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Lead
National Cancer Institute (NCI)
PRIMARY OBJECTIVES:
I. To determine the duration of disease-free survival (DFS) and overall survival (OS) when ZARNESTRA is administered after intensive induction and consolidation chemotherapy to adults with poor risk acute myelogenous leukemia (AML) or high-risk myelodysplasia (MDS) in first complete remission (CR).
SECONDARY OBJECTIVES:
I. To determine the tolerability and toxicities of ZARNESTRA when administered in a chronic dosing schedule over a 48 week period to adults in first CR following intensive cytotoxic chemotherapies.
OUTLINE: This is a multicenter study.
Patients receive oral tipifarnib twice daily on days 1-14. Treatment repeats every 21 days for up to 16 courses in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 14-44 patients will be accrued for this study within 11-15 months.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Pathological Confirmation of the Diagnosis of AML, MDS
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 be 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Ongoing participation in any Phase II or III clinical trial where DFS and OS are primary endpoints (unless patient is withdrawn from that trial)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
Clareo Health | 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)
