NCT00124644

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as cytarabine, daunorubicin, and etoposide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Tipifarnib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving combination chemotherapy together with tipifarnib may kill more cancer cells. PURPOSE: This phase I trial is studying the side effects and best dose of tipifarnib when given together with combination chemotherapy in treating patients with newly diagnosed acute myeloid leukemia.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P50-P75 for phase_1 leukemia

Timeline
Completed

Started Mar 2006

Shorter than P25 for phase_1 leukemia

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 26, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 28, 2005

Completed
7 months until next milestone

Study Start

First participant enrolled

March 1, 2006

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
Last Updated

May 3, 2013

Status Verified

January 1, 2008

Enrollment Period

1.8 years

First QC Date

July 26, 2005

Last Update Submit

May 1, 2013

Conditions

Leukemia

Keywords

adult acute myeloid leukemia with 11q23 (MLL) abnormalitiesadult acute myeloid leukemia with t(16;16)(p13;q22)untreated adult acute myeloid leukemiasecondary acute myeloid leukemia

Interventions

cytarabineDRUG
daunorubicin hydrochlorideDRUG
etoposideDRUG
tipifarnibDRUG
chemotherapyPROCEDURE
enzyme inhibitor therapyPROCEDURE
high-dose chemotherapyPROCEDURE

Eligibility Criteria

Age18 Years - 59 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed acute myeloid leukemia (AML) according to the WHO classification system * High-risk disease * Newly diagnosed disease * Patients with secondary AML due to prior chemotherapy for a different malignancy are eligible * No known inv(16), t(8;21), or t(15;17) cytogenetic abnormality * No acute promyelocytic leukemia * No CNS leukemia PATIENT CHARACTERISTICS: Age * 18 to 59 Performance status * ECOG 0-2 Life expectancy * More than 6 months Hematopoietic * Not specified Hepatic * AST and ALT ≤ 2.5 times upper limit of normal * Bilirubin normal Renal * Creatinine normal OR * Creatinine clearance ≥ 60 mL/min Cardiovascular * Ejection fraction \> 50% by echocardiogram or MUGA * No symptomatic congestive heart failure * No unstable angina pectoris * No cardiac arrhythmia Immunologic * No known HIV positivity * No history of allergic reactions attributed to compounds of similar chemical or biological composition to tipifarnib * No allergy to imidazoles (e.g., clotrimazole, ketoconazole, miconazole, or econazole) * No ongoing or active infection Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No other uncontrolled illness * No psychiatric illness or social situation that would preclude study compliance PRIOR CONCURRENT THERAPY: Biologic therapy * No concurrent epoetin alfa Chemotherapy * See Disease Characteristics * No prior chemotherapy for AML or myelodysplastic syndromes except hydroxyurea Endocrine therapy * Not specified Radiotherapy * No concurrent palliative radiotherapy Surgery * Not specified Other * More than 30 days since prior investigational agents * No other concurrent investigational or commercial agents or therapies for the malignancy

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center

Columbus, Ohio, 43210-1240, United States

Location

MeSH Terms

Conditions

LeukemiaCongenital Abnormalities

Interventions

CytarabineDaunorubicinEtoposidetipifarnibDrug Therapy

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

CytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsArabinonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsAminoglycosidesGlycosidesCarbohydratesPodophyllotoxinTetrahydronaphthalenesNaphthalenesGlucosidesTherapeutics

Study Officials

  • William G. Blum, MD

    Ohio State University Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 26, 2005

First Posted

July 28, 2005

Study Start

March 1, 2006

Primary Completion

December 1, 2007

Study Completion

January 1, 2008

Last Updated

May 3, 2013

Record last verified: 2008-01

Locations

US(1)