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Tipifarnib in Treating Patients With Myelodysplastic Syndrome
This study has been completed.
First Received: June 2, 2000   Last Updated: August 12, 2008   History of Changes
Sponsors and Collaborators: M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00005845
  Purpose

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

PURPOSE: Phase I trial to study the effectiveness of tipifarnib in treating patients who have myelodysplastic syndrome.


Condition Intervention Phase
Leukemia
Myelodysplastic Syndromes
Drug: tipifarnib
Phase I

MedlinePlus related topics: Anemia Cancer Leukemia, Adult Acute Leukemia, Adult Chronic
Drug Information available for: R 115777 Tipifarnib
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment
Official Title: Phase I Study of the Farnesyl Transferase Inhibitor R115777 (NSC 702818) in Patients With Myelodysplastic Syndrome

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

Study Start Date: September 2000
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • Determine the toxicity profile and antitumor activity of tipifarnib in patients with myelodysplastic syndromes.

OUTLINE: This is a dose-escalation study.

Patients receive oral tipifarnib twice daily on weeks 1, 3, 5, and 7. Courses repeat every 8 weeks in the absence of unacceptable toxicity or disease progression.

Cohorts of 3-6 patients receive escalating doses of tipifarnib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. An additional 6 patients are then accrued to receive treatment at the MTD.

PROJECTED ACCRUAL: A total of 40-65 patients will be accrued for this study within 18 months.

  Eligibility

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

DISEASE CHARACTERISTICS:

  • Histologically confirmed myelodysplastic syndromes including the following:

    • Refractory anemia (RA)
    • RA with ringed sideroblasts
    • RA with excess blasts (RAEB)
    • RAEB in transformation
    • Chronic myelomonocytic leukemia
    • Refractory cytopenia with multilineage dysplasia
  • Patients with International Prognostic Scoring System score of 0 must have significant cytopenias of at least 4 weeks duration comprising at least one of the following:

    • Hematocrit no greater than 26%
    • Absolute neutrophil count less than 1,000/mm^3
    • Platelet count no greater than 50,000/mm^3
  • Ineligible for allogeneic bone marrow transplantation (i.e., less than 60 years old, with a histocompatible donor, and no contraindications for transplantation)

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • ECOG 0-2

Life expectancy:

  • More than 12 weeks

Hematopoietic:

  • See Disease Characteristics

Hepatic:

  • Bilirubin no greater than 1.5 mg/dL

Renal:

  • Creatinine no greater than 1.5 mg/dL

Cardiovascular:

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

Other:

  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No other uncontrolled illness
  • No prior allergic reactions attributed to compounds of similar chemical or biological composition to tipifarnib (e.g., imidazoles)
  • No allergy to imidazoles (e.g., clotrimazole, ketoconazole, miconazole, or econazole)
  • No ongoing or active infection
  • No psychiatric illness or social situation that would preclude study compliance

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • At least 2 weeks since prior growth factors (except filgrastim [G-CSF])
  • At least 4 weeks since prior immunotherapy and recovered
  • No concurrent immunotherapy
  • No concurrent growth factors except G-CSF

Chemotherapy:

  • At least 4 weeks since prior chemotherapy (3 months for UCN-01) and recovered
  • At least 24 hours since prior hydroxyurea
  • No other concurrent chemotherapy

Endocrine therapy:

  • At least 4 weeks since prior hormonal therapy and recovered
  • No concurrent hormonal therapy
  • No concurrent steroids

Radiotherapy:

  • At least 4 weeks since prior radiotherapy and recovered
  • No concurrent radiotherapy

Surgery:

  • Not specified

Other:

  • No more than 2 prior therapies
  • No other concurrent agents known to influence the course of myelodysplastic syndromes
  • No other concurrent investigational or commercial agents or therapies for the malignancy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00005845

Locations
United States, Texas
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States, 77030-4009
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Study Chair: Razelle Kurzrock, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
Publications:
Study ID Numbers: CDR0000067862, MDA-DM-99169, NCI-T99-0101, MDA-DM-01582, NCI-5625
Study First Received: June 2, 2000
Last Updated: August 12, 2008
ClinicalTrials.gov Identifier: NCT00005845     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
refractory anemia
refractory anemia with ringed sideroblasts
refractory anemia with excess blasts
refractory anemia with excess blasts in transformation
chronic myelomonocytic leukemia
de novo myelodysplastic syndromes
previously treated myelodysplastic syndromes
secondary myelodysplastic syndromes
refractory cytopenia with multilineage dysplasia

Study placed in the following topic categories:
Chronic Myelomonocytic Leukemia
Precancerous Conditions
Hematologic Diseases
Leukemia, Myelomonocytic, Chronic
Myelodysplastic Syndromes
Anemia
Refractory Anemia
Leukemia
Preleukemia
Anemia, Refractory
Neoplasm Metastasis
Anemia, Refractory, with Excess of Blasts
Bone Marrow Diseases
Tipifarnib

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

ClinicalTrials.gov processed this record on May 07, 2009