Tipifarnib in Treating Patients With Myelodysplastic Syndromes

Completed · Phase 1

Conditions studied: Chronic Myelomonocytic Leukemia, de Novo Myelodysplastic Syndromes, Previously Treated Myelodysplastic Syndromes, Refractory Anemia, Refractory Anemia With Excess Blasts, Refractory Anemia With Excess Blasts in Transformation, Refractory Anemia With Ringed Sideroblasts, Refractory Cytopenia With Multilineage Dysplasia

In brief

This phase I trial studies the side effects and best dose of tipifarnib in treating patients with myelodysplastic syndromes. Tipifarnib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

Key facts

Study ID

NCT00005845

Run by

National Cancer Institute (NCI)

People needed

65

Starts

2002-06-01

Last updated by the study team

2013-12-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• M D Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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