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Tipifarnib in Treating Patients With Myelodysplastic Syndromes | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Tipifarnib in Treating Patients With Myelodysplastic Syndromes

Phase I Study of the Farnesyl Transferase Inhibitor R115777 (NSC #702818) in Patients With Myelodysplastic Syndrome

NCT00005845•National Cancer Institute (NCI)

Summary

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.

Detailed Description

PRIMARY OBJECTIVES: I. To determine the toxicity profile and antitumor activity of the farnesyltransferase (FTase) inhibitor R115777 (tipifarnib) in patients with myelodysplastic syndrome (MDS) treated on a one week on/one week off schedule. II. To determine the effect on R115777 on a one week on/one week off schedule on FTase activity, prenylation of RAS and other substrates and on downstream effects. OUTLINE: This is a dose-escalation study. Patients receive tipifarnib orally (PO) twice daily (BID) on weeks 1, 3, 5, and 7. Treatment repeats every 8 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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)
+9 more criteria

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

Locations (1)

M D Anderson Cancer Center

Houston, Texas, United States

Key Dates

Start Date

June 1, 2002

Primary Completion Date

September 1, 2009

Last Updated

December 16, 2013

Enrollment

ACTUAL participants

Conditions

Chronic Myelomonocytic Leukemiade Novo Myelodysplastic SyndromesPreviously Treated Myelodysplastic SyndromesRefractory AnemiaRefractory Anemia With Excess BlastsRefractory Anemia With Excess Blasts in TransformationRefractory Anemia With Ringed SideroblastsRefractory Cytopenia With Multilineage Dysplasia

Interventions

tipifarnib

DRUG

laboratory biomarker analysis

OTHER

pharmacological study

OTHER

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 16, 2013Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Tipifarnib in Treating Patients With Myelodysplastic Syndromes

Inclusion Criteria

Exclusion Criteria

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