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Safety and Tolerability Study of FPTI in Patients With Leukemia



Safety and Tolerability Study of FPTI in Patients With Leukemia

For Condition: Leukemia, Lymphocytic,Blast Crisis,Leukemia, Myeloid, Chronic,Leukemia,Myelodysplastic Syndromes
Status: No longer recruiting
Sponsor(s): Schering-Plough ,
Synopsis: 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.
Details:
Eligibility:
Study Type:
  Interventional, Treatment, Non-Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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.
Total Enrollment: 90

Location and Contact Information:

Glasgow Royal Infirmary
Glasgow,  , 
United Kingdom
 

Robert H. Lurie Comprehensive Cancer Center of Northwestern University
Chicago,  Illinois, 
United States
 

University of Newcastle upon Tyne
Newcastle upon Tyne,  , 
United Kingdom
 

C.H.U. de Bordeaux, Groupe Hospitalier Bordeaux Sud - Haut Leveque
Pessac,  , 
France
 

Medicinsk-Haematologisk Afd. B
Aarhus C,  , 
Denmark
 

Arizona Cancer Center
Tucson,  Arizona, 
United States
 

University of Minnesota
Minneapolis,  Minnesota, 
United States
 

Seattle Cancer Care Alliance
Seattle,  Washington,  98109-1023
United States
 

C.H.R.U. de Tours, Hospital Bretonneau
Tours,  , 
France
 

C.H.U. de Strabourg, Hopital Civil
Strasbourg,  , 
France
 

Dana Farber Cancer Institute
Boston,  Massachusetts, 
United States
 

Cross Cancer Institute
Edmonton,  Alberta, 
Canada
 

Weill Cornell Medical College
New York City,  New York, 
United States
 

Dana Farber Cancer Institute
Boston,  Massachusetts, 
United States
 

Unitersita di Bologna
Bologna,  , 
Italy
 

Oregon Health Sciences University
Portland,  Oregon, 
United States
 

University Hosipital
Uppsala,  , 
Sweden
 

C.H.U. Hospital de la Miletrie
Poitiers,  , 
France
 

MD Anderson Cancer Center Dept of Leukemia
Houston,  Texas, 
United States
 

C.H.U. Hopital de la Miletrie
Poitiers,  ,  86021
France
 

Princess Margaret Hospital
Toronto,  , 
Canada
 

Hopital Haut Leveque
Pessac Cedex,  ,  33604
France
 

University of Texas
Houston,  Texas, 
United States
 


Additional Information:
Study ID Numbers:
  P00701; 
Study Start Date: June 2001
Record last reviewed: May 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00034684

Other Leukemia, Lymphocytic Studies:
1. Phenylbutyrate and Tretinoin in Treating Patients With Hematologic Cancer

2. Low-Dose Decitabine Compared With Standard Supportive Care in Treating Older Patients With Myelodysplastic Syndrome

3. VNP40101M and Cytarabine in Treating Patients With Hematologic Malignancies

4. Efficacy and safety study of CC-5013 monotherapy in subjects with myelodysplastic syndromes

5. Genetic Study of Patients With Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, or Myelodysplastic Syndromes

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