Tipifarnib in Treating Patients With Myelodysplastic Syndromes

Inclusion Criteria:

Patients must have histologically MDS (including French-American-British [FAB] types refractory anemia [RA], refractory anemia with ringed sideroblasts [RARS], refractory anemia with excess blasts [RAEB], refractory anemia with excess blasts in transformation [RAEBT], or chronic myelomonocytic leukemia [CMMoL]); for the purpose of the study, all patients will be classified by World Health Organization (WHO) criteria

By these criteria, FAB RA are split into:

Pure dyserythropoietic refractory anemia (PRA)

Refractory cytopenia with multilineage dysplasia (RCMD)

FAB RARS is split into:

Pure sideroblastic anemia (PSA)
Refractory sideroblastic cytopenia with multilineage dysplasia (RSCMD)

FAB RAEB is split into:

RAEB I (< 10% BM blasts)
RAEB II (10-20% BM blasts)
Patients with CMMoL, and RAEBT by FAB classification will be included in the protocol
Prognosis will be assessed by International Prognostic Scoring System (IPSS) criteria
=< 2 prior therapies
Eastern Cooperative Oncology Group (ECOG) performance status =< 2
Life expectancy of greater than 12 weeks
Bilirubin =< 1.5mg %
Creatinine =< 1.5mg %
Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

Patients who have had chemotherapy or radiotherapy within 4 weeks (3 months for UCN01) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
Patients may not be receiving any other investigational agents
History of allergic reactions attributed to compounds of similar chemical or biologic composition to R115777 (such as imidazoles)
Patients eligible for bone marrow transplant (=< 60 years old), with a compatible sibling, no contraindications for transplant
Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with R115777.
Growth factors other than filgrastim (G-CSF) are excluded; patients should be off excluded growth factors for 2 weeks