The purpose of this study is to determine the safety and tolerability of an oral Farnesyl Protein Transferase Inhibitor (SCH 66336) as a single agent in patients with Advanced Myelodysplastic Syndrome, Acute Myelogenous Leukemia, Chronic Myelogenous Leukemia in Blast Crisis, or Acute Lymphoblastic Leukemia.

Condition	Treatment or Intervention	Phase
Leukemia Myelodysplastic Syndromes Leukemia, Myeloid, Chronic Blast Crisis Leukemia, Lymphocytic	Drug: Farnesyl Protein Transferase Inhibitor	Phase I Phase II

Further Study Details: 

Expected Total Enrollment:  90

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Pathologically documented chronic myelogenous leukemia in blast crisis, myelodysplasia, acute myelogenous leukemia, or acute lymphocytic leukemia.
• Life expectancy of 12 weeks or greater.
• ECOG Performance Status less than or equal to 2.
• Meets protocol requirements for specified laboratory values.
• No manifestations of a malabsorption syndrome.

Exclusion Criteria:

• Patients who have received more than three chemotherapy regimens for more than three recurrences of the disease.
• Poor medical risks because of nonmalignant systemic disease as well as those with active uncontrolled conditions.
• Patients who have received investigational therapy of any type within 30 days prior to administration.

Arizona
      Arizona Cancer Center, Tucson,  Arizona,  United States
Illinois
      Robert H. Lurie Comprehensive Cancer Center of Northwestern University, Chicago,  Illinois,  United States
Massachusetts
      Dana Farber Cancer Institute, Boston,  Massachusetts,  United States
      Dana Farber Cancer Institute, Boston,  Massachusetts,  United States
Minnesota
      University of Minnesota, Minneapolis,  Minnesota,  United States
New York
      Weill Cornell Medical College, New York,  New York,  United States
Oregon
      Oregon Health Sciences University, Portland,  Oregon,  United States
Texas
      MD Anderson Cancer Center Dept of Leukemia, Houston,  Texas,  United States
      University of Texas, Houston,  Texas,  United States
Washington
      Seattle Cancer Care Alliance, Seattle,  Washington,  98109-1023,  United States
Canada
      Princess Margaret Hospital, Toronto,  Canada
Canada, Alberta
      Cross Cancer Institute, Edmonton,  Alberta,  Canada
Denmark
      Medicinsk-Haematologisk Afd. B, Aarhus C,  Denmark
France
      C.H.U. Hopital de la Miletrie, Poitiers,  86021,  France
      Hopital Haut Leveque, Pessac Cedex,  33604,  France
      C.H.U. de Strabourg, Hopital Civil, Strasbourg,  France
      C.H.U. Hospital de la Miletrie, Poitiers,  France
      C.H.U. de Bordeaux, Groupe Hospitalier Bordeaux Sud - Haut Leveque, Pessac,  France
      C.H.R.U. de Tours, Hospital Bretonneau, Tours,  France
Italy
      Unitersita di Bologna, Bologna,  Italy
Sweden
      University Hosipital, Uppsala,  Sweden
United Kingdom
      University of Newcastle upon Tyne, Newcastle upon Tyne,  United Kingdom
      Glasgow Royal Infirmary, Glasgow,  United Kingdom

Study ID Numbers:  P00701
Record last reviewed:  October 2004
Last Updated:  October 21, 2004
Record first received:  May 1, 2002
ClinicalTrials.gov Identifier:  NCT00034684
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08