Chronic Myelomonocytic Leukemia Clinical Trial
Official title:
Phase I/II Study of Tipifarnib [Zarnestra, Farnesyltransferase Inhibitor R115777 (NSC 702818)] in Patients With Myeloproliferative Disorders
This phase 1-2 trial studies the side effects and how well tipifarnib works in treating patients with chronic myeloid leukemia, chronic myelomonocytic leukemia, or undifferentiated myeloproliferative disorders. Tipifarnib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
PRIMARY OBJECTIVES:
- To describe the toxicities of R115777 (tipifarnib) in adult patients with
myeloproliferative disorders.
- To assess hematologic responses, including changes in white blood cell count and
erythroid responses.
SECONDARY OBJECTIVES:
- To assess bone marrow cytogenetic responses to R115777.
- To analyze for the presence of neuroblastoma (N)/Kirsten rat sarcoma viral oncogene
homolog (K-Ras) mutations in patient bone marrow samples.
- To analyze the effect of R115777 on Ras /DnaJ (Hsp40) homolog, subfamily A, member
1(HDJ-2) farnesylation in patient bone marrow/peripheral blood mononuclear cells.
- To analyze the effect of R115777 on mitogen-activated protein (MAP) kinase activation in
patient bone marrow mononuclear cells.
- To perform colony forming unit granulocyte-macrophage (CFU-GM) cytotoxicity assays using
patients' hematopoietic cells with R115777.
OUTLINE:
Patients receive tipifarnib orally (PO) twice daily (BID) on days 1-21. Treatment repeats
every 28 days for up to 4 courses in the absence of disease progression or unacceptable
toxicity. Patients achieving a good hematologic response may continue treatment at the
discretion of the treating physician.
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