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Home > "T" Clinical Trials Conditions > Tipifarnib in Treating Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome in Complete Remission  Tipifarnib in Treating Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome in Complete Remission
Tipifarnib in Treating Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome in Complete Remission
For Condition: adult acute monocytic leukemia,adult acute myeloid leukemia,Chronic Myelomonocytic Leukemia,Myelodysplastic Syndromes
Status: Recruiting
Sponsor(s): Sidney Kimmel Cancer Center , National Cancer Institute (NCI)
Synopsis: 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.
Details: 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 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:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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 - Newly diagnosed, previously untreated disease in early first complete remission after induction and consolidation chemotherapy with timed sequential therapy (3+7 or 3+10) with or without additional cytotoxic agents (e.g., etoposide), high-dose cytarabine, or other defined cytotoxic regimens with agents such as mitoxantrone and/or topotecan - No more than 21-35 days since hospital discharge after marrow recovery - 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JudithKarp, Study Chair, Sidney Kimmel Cancer Center
James P. Wilmot Cancer Center at University of Rochester Medical Center *Recruiting*
Rochester, New York, 14642
United States
Recruiting Jeffrey Lancet 716-273-3258
Mayo Clinic Cancer Center *Recruiting*
Rochester, Minnesota, 55905
United States
Recruiting Ruben Mesa 507-284-3533
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins *Recruiting*
Baltimore, Maryland, 21231
United States
Recruiting Judith Karp 410-502-7726
Blood and Marrow Transplant Group of Georgia *Recruiting*
Atlanta, Georgia, 30342-4777
United States
Recruiting Lawrence Morris 404-255-1930
Marlene and Stewart Greenebaum Cancer Center, University of Maryland *Recruiting*
Baltimore, Maryland, 21201
United States
Recruiting Ivana Gojo 410-328-2565
Additional Information:
Study ID Numbers: CDR0000256885; MSGCC-0150,NCI-5689,JHOC-J0252
Study Start Date:
Record last reviewed: September 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00045396
Other Chronic Myelomonocytic Leukemia Studies:
1. Azacitidine Plus Phenylbutyrate in Treating Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome
2. Busulfan and Cyclophosphamide Followed by Bone Marrow Transplantation in Treating Patients With Acute Myelogenous Leukemia or Myelodysplastic Syndrome
3. Tipifarnib in Treating Older Patients With Previously Untreated Acute Myeloid Leukemia
4. Combination Chemotherapy Followed by Peripheral Stem Cell Transplantation and Interleukin-2 in Treating Patients With Acute Leukemia
5. Biological Therapy in Treating Patients With Advanced Acute Myeloid Leukemia or Acute Lymphoblastic Leukemia Who Are Undergoing Stem Cell Transplantation
Related Studies:
Other Chronic Myelomonocytic Leukemia Clinical Trials
Other Minnesota Clinical Trials
Other Rochester Clinical Trials
Tipifarnib in Treating Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome in Complete Remission
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