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Tipifarnib in Treating Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome in Complete Remission
This study has been completed.
First Received: September 6, 2002   Last Updated: August 22, 2008   History of Changes
Sponsor: Sidney Kimmel Comprehensive Cancer Center
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00045396
  Purpose

RATIONALE: Tipifarnib may stop the growth of cancer cells by blocking the enzymes necessary for their growth.

PURPOSE: Phase II trial to study the effectiveness of tipifarnib in treating patients who have acute myeloid leukemia or myelodysplastic syndrome in first complete remission.


Condition Intervention Phase
Leukemia
Myelodysplastic Syndromes
Drug: tipifarnib
Phase II

Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: A Phase II Study Of The Farnesyltransferase Inhibitor ZANESTRA (R115777, NSC #702818, IND #58,359) In Complete Remission Following Induction And/Or Consolidation Chemotherapy In Adults With Poor-Risk Acute Myelogenous Leukemia (AML) And High-Risk Myelodysplasia (MDS)

Resource links provided by NLM:


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

Primary Outcome Measures:
  • 6-month disease-free survival [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Tolerability and toxicity [ Designated as safety issue: Yes ]

Estimated Enrollment: 44
Study Start Date: August 2002
Detailed Description:

OBJECTIVES:

  • Determine the duration of disease-free survival and overall survival of patients with poor-risk acute myeloid leukemia or high-risk myelodysplastic syndromes in early first complete remission treated with tipifarnib.
  • Determine the tolerability and toxic effects of this drug in these patients.

OUTLINE: This is a multicenter study.

Patients receive oral tipifarnib twice daily on days 1-14. Treatment repeats every 21 days for up to 16 courses in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 14-44 patients will be accrued for this study within 11-15 months.

  Eligibility

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

DISEASE CHARACTERISTICS:

  • Histologically confirmed diagnosis of 1 of the following:

    • Poor-risk acute myeloid leukemia (AML), defined as any of the following:

      • Antecedent hematologic disorder
      • AML arising from myelodysplastic syndromes (MDS)
      • Therapy-related AML
      • 60 years of age or over (in absence of favorable cytogenetics)
      • Adverse cytogenetics (e.g., -5/5q, -7/7q, 20q-, or 11q23 abnormalities or complex karyotype)
      • Hyperleukocytosis at diagnosis (e.g., blasts at least 50,000/mm^3 in absence of favorable cytogenetics)
      • No acute promyelocytic leukemia (FAB M3 subtype)
    • High-risk myelodysplastic syndromes (MDS), defined as any of the following:

      • Chronic myelomonocytic leukemia with more than 5% marrow blasts
      • Therapy-related MDS
      • Refractory anemia with excess blasts (RAEB) with IPSS score at least 1.5
      • RAEB in transformation with IPSS score at least 1.5
  • In early first complete remission after completing induction and consolidation chemotherapy

    • No more than 21-35 days since hospital discharge after marrow recovery from consolidation therapy
    • No more than 120 days since initiation of the final course of consolidation therapy
  • No presence of residual AML (more than 5% marrow blasts) or MDS by morphology, flow cytometry, and/or cytogenetics
  • No active CNS leukemia
  • No presence of (8;21) translocation or inversion 16 genotype as sole abnormality
  • Ineligible for curative allogeneic stem cell transplantation

PATIENT CHARACTERISTICS:

Age

  • See Disease Characteristics
  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • Not specified

Hematopoietic

  • Polymorphonuclear cell count at least 1,000/mm^3
  • Platelet count at least 30,000/mm^3*
  • Hemoglobin at least 9 g/dL*
  • Hematocrit at least 27%* NOTE: *Unsupported

Hepatic

  • Bilirubin no greater than 1.5 times normal
  • AST and ALT no greater than 2.5 times normal
  • Alkaline phosphatase no greater than 2.5 times normal

Renal

  • Creatinine no greater than 2.0 mg/dL OR
  • Creatinine clearance at least 40 mL/min

Cardiovascular

  • No disseminated intravascular coagulation
  • LVEF at least 25%

Other

  • No active uncontrolled infection
  • No known allergy to imidazole drugs (e.g., ketoconazole or miconazole)
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No concurrent immunotherapy

Chemotherapy

  • See Disease Characteristics
  • No concurrent chemotherapy

Endocrine therapy

  • Not specified

Radiotherapy

  • No concurrent radiotherapy

Surgery

  • Not specified

Other

  • No prior tipifarnib
  • No concurrent participation in another phase II or phase III study in which disease-free survival and overall survival are primary endpoints
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00045396

Locations
United States, Georgia
Blood and Marrow Transplant Group of Georgia
Atlanta, Georgia, United States, 30342
United States, Maryland
Greenebaum Cancer Center at University of Maryland Medical Center
Baltimore, Maryland, United States, 21201
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410
United States, New York
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester, New York, United States, 14642
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center
Investigators
Study Chair: Judith E. Karp, MD Sidney Kimmel Comprehensive Cancer Center
  More Information

Additional Information:
Publications:
Study ID Numbers: CDR0000256885, JHOC-J0252, MSGCC-0150, NCI-5689
Study First Received: September 6, 2002
Last Updated: August 22, 2008
ClinicalTrials.gov Identifier: NCT00045396     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
adult acute monocytic leukemia (M5b)
adult acute erythroid leukemia (M6)
adult acute megakaryoblastic leukemia (M7)
adult acute minimally differentiated myeloid leukemia (M0)
adult acute myeloblastic leukemia with maturation (M2)
adult acute myeloblastic leukemia without maturation (M1)
adult acute myeloid leukemia in remission
adult acute myelomonocytic leukemia (M4)
adult acute monoblastic leukemia (M5a)
chronic myelomonocytic leukemia
previously treated myelodysplastic syndromes
refractory anemia with excess blasts
refractory anemia with excess blasts in transformation
secondary myelodysplastic syndromes
adult acute myeloid leukemia with 11q23 (MLL) abnormalities

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Disease
Precancerous Conditions
Antineoplastic Agents
Hematologic Diseases
Myelodysplastic Syndromes
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Pharmacologic Actions
Leukemia
Preleukemia
Neoplasms
Pathologic Processes
Therapeutic Uses
Syndrome
Bone Marrow Diseases
Tipifarnib

ClinicalTrials.gov processed this record on November 27, 2009