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Tipifarnib in Treating Patients With Acute Myeloid Leukemia in Remission

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00093470
First received: October 6, 2004
Last updated: January 8, 2013
Last verified: January 2013
History of Changes
  Purpose

Tipifarnib may stop the growth of cancer cells by blocking the enzymes necessary for their growth. It is not yet known whether tipifarnib is more effective than observation alone in preventing the recurrence of acute myeloid leukemia. This randomized phase III trial is studying how well tipifarnib works compared to observation alone in preventing cancer recurrence in patients with acute myeloid leukemia


Condition Intervention Phase
Adult Acute Megakaryoblastic Leukemia (M7)
Adult Acute Minimally Differentiated Myeloid Leukemia (M0)
Adult Acute Monocytic Leukemia (M5b)
Adult Acute Myeloblastic Leukemia With Maturation (M2)
Adult Acute Myeloblastic Leukemia Without Maturation (M1)
Adult Acute Myeloid Leukemia
Adult Acute Myeloid Leukemia in Remission
Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)
Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)
Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)
Adult Acute Myelomonocytic Leukemia (M4)
Adult Erythroleukemia (M6a)
Recurrent Adult Acute Myeloid Leukemia
Refractory Anemia With Excess Blasts in Transformation
 Drug: tipifarnib
Procedure: clinical observation
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase III Randomized Study of Farnesyl Transferase Inhibitor R115777 in Acute Myeloid Leukemia (AML) Patients in Second or Subsequent Remission or in Remission After Primary Induction Failure

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Disease-free survival [ Time Frame: From randomization until relapse or death from any cause, up to 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Time Frame: From randomization until death from any cause, up to 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 139
Study Start Date: August 2004
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I
Patients receive oral tipifarnib twice daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
 Drug: tipifarnib
Given orally
Other Names:
  • R115777
  • Zarnestra
Arm II
Patients undergo observation only.
 Procedure: clinical observation
Undergo observation
Other Name: observation

Detailed Description:

PRIMARY OBJECTIVES:

I. Compare disease-free survival in patients with acute myeloid leukemia in second or subsequent complete remission or in first complete remission treated with tipifarnib as maintenance therapy vs observation alone.

SECONDARY OBJECTIVES:

I. Compare overall survival in patients treated with these regimens. II. Determine long-term safety and toxicity of tipifarnib in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to remission status (first complete remission [CR] vs > first CR) and prior treatment for the most current remission (consolidation therapy vs no therapy). Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive oral tipifarnib twice daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

ARM II: Patients undergo observation only.

Patients are followed for up to 5 years.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Morphologically confirmed acute myeloid leukemia (AML) of 1 of the following types:

    • Acute myeloblastic leukemia (M0, M1, or M2)
    • Acute myelomonocytic leukemia (M4)
    • Acute monocytic leukemia (M5)
    • Acute erythroleukemia (M6)
    • Acute megakaryocytic leukemia (M7)
    • Refractory anemia with excess blasts in transformation
    • AML with multilineage dysplasia

  • In complete remission (CR) or molecular remission (MR) by blood counts and bone marrow studies* AND meets 1 of the following criteria:

    • In first CR after primary induction failure
    • Must have received at least 2 induction chemotherapy regimens
    • In second or subsequent CR
    • In first remission AND > 60 years of age NOTE: *Patients with CR documented by hematologic parameters are eligible provided current bone marrow studies confirm CR

  • Patients must meet 1 of the following criteria:

    • Achieved remission within the past 60 days
    • Completed induction or post-remission therapy within the past 60 days
    • Achieved hematologic recovery from chemotherapy within the past 60 days
  • Extramedullary disease allowed if in CR and not requiring therapy
  • No acute promyelocytic leukemia (FAB M3)

  • Performance status:

    • ECOG 0-2

  • Hematopoietic:

    • Absolute neutrophil count >= 1,000/mm^3
    • Platelet count >= 50,000/mm^3

  • Hepatic:

    • Bilirubin < 2 mg/dL
    • AST and ALT =< 2.5 times upper limit of normal (ULN)
    • No active hepatic disease

  • Renal:

    • Creatinine =< 1.5 times ULN
    • No active renal disease

  • Cardiovascular:

    • No active uncontrolled cardiac disease

  • Pulmonary:

    • No active uncontrolled pulmonary disease
  • No known allergy to imidazole drugs* (e.g., clotrimazole, ketoconazole, miconazole, econazole, or terconazole)
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception NOTE: * Excludes fluconazole, voriconazole, or itraconazole
  • Prior autologous stem cell transplantation allowed
  • Prior allogeneic bone marrow transplantation allowed provided treatment did not take place during the current remission
  • Recovered from prior chemotherapy
  • Prior consolidation chemotherapy allowed
  • No concurrent hepatic enzyme-inducing anticonvulsants
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00093470

  Show 220 Study Locations
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
Principal Investigator: Selina Luger Eastern Cooperative Oncology Group
  More Information

No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00093470     History of Changes
Other Study ID Numbers: NCI-2009-00535, E2902, U10CA021115, CDR0000387995
Study First Received: October 6, 2004
Last Updated: January 8, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Congenital Abnormalities
Anemia
Anemia, Refractory
Anemia, Refractory, with Excess of Blasts
Leukemia
Leukemia, Erythroblastic, Acute
Leukemia, Megakaryoblastic, Acute
Leukemia, Monocytic, Acute
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Leukemia, Myelomonocytic, Acute
Leukemia, Myelomonocytic, Chronic
 Anemia, Aplastic
Hematologic Diseases
Myelodysplastic Syndromes
Bone Marrow Diseases
Neoplasms by Histologic Type
Neoplasms
Myeloproliferative Disorders
Myelodysplastic-Myeloproliferative Diseases
Tipifarnib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013