Tipifarnib and Etoposide in Treating Older Patients With Newly Diagnosed, Previously Untreated Acute Myeloid Leukemia

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Brief Title

Tipifarnib and Etoposide in Treating Older Patients With Newly Diagnosed, Previously Untreated Acute Myeloid Leukemia

Official Title

A Randomized Phase II Trial of Tipifarnib (R115777, ZARNESTRA, NSC #702818) in Combination With Oral Etoposide (VP-16) in Elderly Adults With Newly Diagnosed, Previously Untreated Acute Myelogenous Leukemia (AML)

Brief Summary

      This randomized phase II trial is studying the side effects and how well giving tipifarnib
      together with etoposide works in treating older patients with newly diagnosed, previously
      untreated acute myeloid leukemia. Tipifarnib may stop the growth of cancer cells by blocking
      some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as etoposide,
      work in different ways to stop the growth of cancer cells, either by killing the cells or by
      stopping them from dividing. Giving tipifarnib together with etoposide may kill more cancer
      cells.
    

Detailed Description

      OBJECTIVES:

      I. To compare the efficacy and toxicity of two schedules of tipifarnib plus etoposide as
      induction therapy in older patients with newly diagnosed, previously untreated acute myeloid
      leukemia.

      II. To study mechanisms of leukemia cell resistance to tipifarnib in combination with
      etoposide.

      OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.

      ARM I: Patients receive 600 mg of oral tipifarnib twice daily on days 1-14 and 100 mg of oral
      etoposide once daily on days 1-3 and 8-10.

      ARM II: Patients receive 400 mg of oral tipifarnib twice daily on days 1-14 and 200 mg of
      oral etoposide once daily on days 1-3 and 8-10. (closed to accrual as of November 2008)

      Treatment in both arms repeats every 28 days in the absence of disease progression or
      unacceptable toxicity.

      After completion of study treatment, patients are followed at 30 days and then every 90 days
      thereafter.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Complete Response


Condition

Acute Myeloid Leukemia With Multilineage Dysplasia Following Myelodysplastic Syndrome

Intervention

tipifarnib

Study Arms / Comparison Groups

 Arm I
Description:  Patients receive 600 mg of oral tipifarnib twice daily on days 1-14 and 100 mg of oral etoposide once daily on days 1-3 and 8-10.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

84

Start Date

January 2008

Completion Date

October 2011

Primary Completion Date

October 2011

Eligibility Criteria

        Criteria:

          -  Pathologically confirmed newly diagnosed acute myeloid leukemia (AML)

          -  Subtypes M0, M1, M2, M4-7 disease

          -  No newly diagnosed acute promyelocytic leukemia (M3)

          -  Any of the following diseases:

          -  De novo disease

          -  Secondary AML

          -  Myelodysplasia (MDS)-related AML (MDS/AML)

          -  Treatment-related AML

          -  Previously untreated disease

          -  Patients who have received prior hydroxyurea alone or non-cytotoxic therapies for MDS
             (e.g., thalidomide, interferon, cytokines, 5-azacytidine, or revlimid) will be
             eligible for this study

          -  Must be considered ineligible for traditional antileukemia chemotherapy

          -  No hyperleukocytosis with ≥ 30,000 blasts/uL or rapidly rising blast count with
             projected doubling time of =< 2 days

          -  Patients may receive hydroxyurea to lower blast count to < 30,000 blasts/uL up to 24
             hours before beginning tipifarnib and etoposide

          -  No active CNS leukemia

          -  No prior tipifarnib or etoposide

          -  No concurrent radiotherapy, immunotherapy, or other chemotherapy

          -  No concurrent enzyme-inducing anticonvulsants (e.g., phenytoin, fosphenytoin,
             phenobarbital, primidone, carbamazepine, or oxcarbazepine)

          -  Patients may be changed to non-enzyme-inducing anticonvulsants and stabilized before
             starting study treatment

        Inclusion Criteria:

          -  ECOG performance status 0-2

          -  Serum creatinine =< 2.0 mg/dL

          -  SGOT and SGPT =< 3 times upper limit of normal

          -  Bilirubin =< 2 mg/dL

        Exclusion Criteria:

          -  Active, uncontrolled infection

          -  Patients with infection under active treatment and controlled with antimicrobials are
             eligible

          -  Presence of other life-threatening illnesses

          -  Patients with mental deficits and/or psychiatric history that preclude them from
             giving informed consent or from following protocol

          -  Allergies to imidazoles (e.g., clotrimazole, ketoconazole, miconazole, or econazole)
      

Gender

All

Ages

70 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Judith Karp, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00602771

Organization ID

NCI-2009-00278

Secondary IDs

NCI-2009-00278

Responsible Party

Sponsor

Study Sponsor

National Cancer Institute (NCI)


Study Sponsor

Judith Karp, Principal Investigator, Johns Hopkins University/Sidney Kimmel Cancer Center


Verification Date

June 2014