Decentrialz logo
  • HIPAA Compliant
  • ISO 27001 Certified
Find Trials
About UsContact
Become a Volunteer+1 877 705 1914

Status:

COMPLETED

Tipifarnib, Cytarabine, and Daunorubicin in Treating Older Patients With Acute Myeloid Leukemia

Lead Sponsor:

University Health Network, Toronto

Collaborating Sponsors:

National Cancer Institute (NCI)

Conditions:

Leukemia

Eligibility:

All Genders

56+ years

Phase:

PHASE1

Brief Summary

RATIONALE: Tipifarnib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cytarabine and daunorubicin, work in different way...

Detailed Description

OBJECTIVES: * Determine the maximum tolerated dose of tipifarnib when administered with cytarabine and daunorubicin in older patients with previously untreated acute myeloid leukemia. * Determine the...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • Diagnosis of acute myeloid leukemia (AML)
  • All subtypes, except acute promyelocytic leukemia, are allowed
  • At least 20% bone marrow or peripheral blood blasts OR biopsy-confirmed extramedullary disease
  • No cerebrospinal fluid involvement
  • PATIENT CHARACTERISTICS:
  • Age
  • 56 and over
  • Performance status
  • ECOG 0-2 OR
  • Karnofsky 60-100%
  • Life expectancy
  • Not specified
  • Hematopoietic
  • See Disease Characteristics
  • WBC \< 100,000/mm\^3 (treatment with hydroxyurea allowed)
  • Hepatic
  • Bilirubin ≤ 1.25 times upper limit of normal (ULN)
  • AST and ALT ≤ 2.0 times ULN
  • Renal
  • Creatinine \< 1.7 mg/dL OR
  • Creatinine clearance ≥ 60 mL/min
  • Cardiovascular
  • LVEF ≥ 50%
  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • No cardiac arrhythmia
  • Immunologic
  • HIV negative
  • No history of allergic reaction attributed to compounds of similar chemical or biologic composition to tipifarnib or imidazole drugs (e.g., ketoconazole, clotrimazole, or miconazole)
  • No ongoing or active infection
  • Other
  • Not pregnant
  • Fertile patients must use effective contraception
  • Able to swallow oral medications
  • No other uncontrolled illness
  • No psychiatric illness or social situation that would preclude study compliance
  • PRIOR CONCURRENT THERAPY:
  • Biologic therapy
  • Not specified
  • Chemotherapy
  • No prior chemotherapy for AML except hydroxyurea for cytoreduction
  • More than 4 weeks since prior chemotherapy except hydroxyurea (6 weeks for nitrosoureas or mitomycin) and recovered
  • At least 24 hours since prior hydroxyurea
  • Endocrine therapy
  • No concurrent dexamethasone
  • Radiotherapy
  • More than 4 weeks since prior radiotherapy and recovered
  • No prior radiotherapy \> 3,000 cGy to marrow-producing areas
  • Surgery
  • Not specified
  • Other
  • No other concurrent investigational agents
  • No other concurrent antileukemic agents
  • No concurrent treatment with any of the following:
  • Ketoconazole
  • Itraconazole
  • Voriconazole
  • Clarithromycin
  • Erythromycin
  • Phenytoin
  • Carbamazepine
  • Barbiturates
  • Cyclosporine
  • Pimozide
  • Warfarin
  • Grapefruit juice
  • Simvastatin
  • Lovastatin
  • Atorvastatin
  • No concurrent magnesium- or aluminum-containing antacids within 2 hours before or after tipifarnib administration

Exclusion

    Key Trial Info

    Start Date :

    April 1 2007

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    Estimated Enrollment :

    24 Patients enrolled

    Trial Details

    Trial ID

    NCT00101153

    Start Date

    April 1 2007

    Last Update

    July 23 2015

    Active Locations (2)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 1 (2 locations)

    1

    McMaster Children's Hospital at Hamilton Health Sciences

    Hamilton, Ontario, Canada, L8N 3Z5

    2

    London Regional Cancer Program at London Health Sciences Centre

    London, Ontario, Canada, N6A 465