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Tipifarnib in Treating Patients With Myelofibrosis and Myeloid Metaplasia
This study has been completed.

First Received on October 3, 2002.   Last Updated on May 17, 2011   History of Changes
Sponsor: Mayo Clinic
Collaborator: National Cancer Institute (NCI)
Information provided by: Mayo Clinic
ClinicalTrials.gov Identifier: NCT00047190
  Purpose

RATIONALE: Tipifarnib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth.

PURPOSE: Phase II trial to study the effectiveness of tipifarnib in treating patients who have myelofibrosis with myeloid metaplasia.


Condition Intervention Phase
Chronic Myeloproliferative Disorders
 Drug: tipifarnib
 Phase II

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Trial of R115777 in Myelofibrosis With Myeloid Metaplasia (MMM)

Resource links provided by NLM:

Genetics Home Reference related topics: essential thrombocythemia polycythemia vera primary myelofibrosis
MedlinePlus related topics: Cancer
Drug Information available for: R 115777 Tipifarnib
U.S. FDA Resources

Further study details as provided by Mayo Clinic:

Study Start Date: August 2002
Study Completion Date: January 2007
Primary Completion Date: April 2004 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • Determine the response rate in patients with myelofibrosis with myeloid metaplasia treated with tipifarnib.
  • Determine the toxicity of this drug in these patients.
  • Determine the effect of this drug on disease-associated anemia, palpable splenomegaly, and hypercatabolic symptoms in these patients.
  • Determine the effect of this drug on the pathologic increase in circulating myeloid progenitors from baseline to after the first course in these patients.
  • Correlate response/relapse in these patients with in vitro myeloid colony sensitivity to this drug.
  • Determine the effect of this drug on bone marrow histologic features (osteosclerosis, reticulin fibrosis, and angiogenesis) in these patients.

OUTLINE: This is a multicenter study.

Patients receive oral tipifarnib twice daily on days 1-21. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months until disease progression and then every 6 months for up to 2 years.

PROJECTED ACCRUAL: A total of 18-35 patients will be accrued for this study within 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 myelofibrosis with myeloid metaplasia

    • Agnogenic myeloid metaplasia
    • Post-polycythemic myeloid metaplasia
    • Post-thrombocythemic myeloid metaplasia
  • Bone marrow must show reticulin fibrosis and peripheral blood smear must show leukoerythroblastosis and dacrocytosis

  • Bone marrow must not show evidence of other conditions associated with myelofibrosis, including the following:

    • Metastatic carcinoma
    • Lymphoma
    • Myelodysplasia
    • Hairy cell leukemia
    • Mast cell disease
    • Acute leukemia (including M7 type)
    • Acute myelofibrosis
  • Absence of chromosomal translocation t(9:22) by bone marrow chromosome analysis or peripheral blood or bone marrow fluorescent in situ hybridization (FISH)

  • At least 1 of the following must be present:

    • Anemia evidenced by hemoglobin less than 10 g/dL
    • Palpable hepatosplenomegaly

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • Not specified

Hematopoietic

  • See Disease Characteristics
  • Absolute neutrophil count at least 750/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic

  • Bilirubin no greater than upper limit of normal (ULN)
  • AST no greater than 2.5 times ULN
  • Alkaline phosphatase no greater than 3 times ULN (unless secondary to disease)

Renal

  • Creatinine no greater than 1.5 times ULN

Cardiovascular

  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • No cardiac arrhythmia

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No other concurrent uncontrolled illness or comorbid condition that would preclude study participation
  • No ongoing or active infection
  • No psychiatric illness or social situation that would preclude study participation
  • No known quinolone sensitivity

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No concurrent epoetin alfa
  • No concurrent prophylactic colony-stimulating factors (filgrastim [G-CSF] or sargramostim [GM-CSF])
  • No concurrent thalidomide

Chemotherapy

  • More than 2 weeks since prior cytotoxic chemotherapy

Endocrine therapy

  • Not specified

Radiotherapy

  • Not specified

Surgery

  • Not specified

Other

  • More than 2 weeks since prior myelosuppressive agents
  • No other concurrent therapy directed at the disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00047190

Locations
United States, Arizona
Mayo Clinic Scottsdale
Scottsdale, Arizona, United States, 85259
United States, District of Columbia
Howard University College of Medicine
Washington, District of Columbia, United States, 20059
United States, Florida
Mayo Clinic
Jacksonville, Florida, United States, 32224
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231
United States, Michigan
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
United States, Minnesota
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
United States, Wisconsin
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
Mayo Clinic
National Cancer Institute (NCI)
Investigators
Study Chair: Ruben A. Mesa, MD Mayo Clinic
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Publications:
Mesa RA, Camoriano JK, Geyer SM, Wu W, Kaufmann SH, Rivera CE, Erlichman C, Wright J, Pardanani A, Lasho T, Finke C, Li CY, Tefferi A. A phase II trial of tipifarnib in myelofibrosis: primary, post-polycythemia vera and post-essential thrombocythemia. Leukemia. 2007 Jun 21; [Epub ahead of print]

Responsible Party: Ruben A. Mesa, M.D., Mayo Clinic
ClinicalTrials.gov Identifier: NCT00047190     History of Changes
Other Study ID Numbers: CDR0000257568, P30CA015083, MC0184, 5576
Study First Received: October 3, 2002
Last Updated: May 17, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Mayo Clinic:
primary myelofibrosis
polycythemia vera
essential thrombocythemia

Additional relevant MeSH terms:
Primary Myelofibrosis
Metaplasia
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
 Pathologic Processes
Tipifarnib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012



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