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Home > "T" Clinical Trials Conditions > Tipifarnib in Treating Older Patients With Previously Untreated Acute Myeloid Leukemia  Tipifarnib in Treating Older Patients With Previously Untreated Acute Myeloid Leukemia
Tipifarnib in Treating Older Patients With Previously Untreated Acute Myeloid Leukemia
For Condition: adult acute myeloid leukemia,adult acute monocytic leukemia
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 older patients who have previously untreated acute myeloid leukemia.
Details: OBJECTIVES: Primary - Determine the complete response rate in older patients with previously untreated poor-risk acute myeloid leukemia treated with tipifarnib. Secondary - Determine the progression-free and overall survival of patients treated with this drug. - Determine the duration of response in patients treated with this drug. - Determine the effect of this drug on the phosphorylation of mitogen-activated protein kinase (MAPK) and phosphatidyl inositol 3 kinase (PI3K) in leukemic cells in these patients. - Determine the toxic effects of this drug in these patients. OUTLINE: This is a multicenter study. Patients receive oral tipifarnib twice daily on days 1-21. Patients with a complete or partial response, hematologic improvement, or stable disease continue treatment every 29-63 days in the absence of disease progression or unacceptable toxicity. Patients with a complete response after the second course of therapy receive 2 additional courses of therapy. Patients are followed for survival. PROJECTED ACCRUAL: A total of 125 patients will be accrued for this study within 11-17 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 65 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed newly diagnosed acute myeloid leukemia (AML) - At least 20% blasts in bone marrow - AML arising from myelodysplastic syndromes (MDS) - No acute promyelocytic leukemia (M3) - No hyperleukocytosis (at least 30,000 leukemic blasts/mm^3) - No active CNS leukemia - Ineligible for curative allogeneic stem cell transplantation PATIENT CHARACTERISTICS: Age: - 65 and over Performance status: - ECOG 0-2 Life expectancy: - Not specified Hematopoietic: - No disseminated intravascular coagulation (laboratory or clinical) Hepatic: - Bilirubin normal - SGOT and SGPT no greater than 2.5 times normal Renal: - Creatinine no greater than 1.5 times normal Cardiovascular: - No severe congestive heart failure - No unstable angina Other: - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No active systemic infection - No known allergy to imidazole drugs (e.g., ketoconazole, miconazole, econazole, terconazole, clotrimazole, fenticonazole, isoconazole, sulconazole, or tioconazole)) - No physical or psychiatric condition that would preclude study compliance - No poorly controlled psychosis - No symptomatic neuropathy grade 2 or greater PRIOR CONCURRENT THERAPY: Biologic therapy: - See Disease Characteristics - No concurrent immunotherapy Chemotherapy: - No prior chemotherapy for leukemia except hydroxyurea - No concurrent chemotherapy Endocrine therapy: - Not specified Radiotherapy: - No concurrent radiotherapy Surgery: - Not specified Other: - At least 1 month since prior therapy for another malignancy
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JudithKarp, Study Chair, Sidney Kimmel Cancer Center
Mayo Clinic Cancer Center *Recruiting*
Rochester, Minnesota, 55905
United States
Recruiting Scott Kaufmann 507-284-2511
Marlene and Stewart Greenebaum Cancer Center, University of Maryland *Recruiting*
Baltimore, Maryland, 21201
United States
Recruiting Ivana Gojo 410-328-2565
Stanford Cancer Center at Stanford University Medical Center *Recruiting*
Stanford, California, 94305-5750
United States
Recruiting Peter Greenberg 650-725-8355
James P. Wilmot Cancer Center at University of Rochester Medical Center *Recruiting*
Rochester, New York, 14642
United States
Recruiting Jeffrey Lancet 716-273-3258
New York Weill Cornell Cancer Center at Cornell University *Recruiting*
New York City, New York, 10021
United States
Recruiting Eric Feldman 212-746-6736
Blood and Marrow Transplant Group of Georgia *Recruiting*
Atlanta, Georgia, 30342-4777
United States
Recruiting Lawrence Morris 404-255-1930
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins *Recruiting*
Baltimore, Maryland, 21231
United States
Recruiting Judith Karp 410-502-7726
Additional Information:
Study ID Numbers: CDR0000069089; MSGCC-U5400,MSGCC-0116,NCI-1754,JHOC-J0255
Study Start Date:
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00027872
Other Adult Acute Monocytic Leukemia Studies:
1. Busulfan and Cyclophosphamide Followed by Bone Marrow Transplantation in Treating Patients With Acute Myelogenous Leukemia or Myelodysplastic Syndrome
2. Chemotherapy With or Without Gemtuzumab Ozogamicin in Treating Older Patients With Acute Myeloid Leukemia
3. Daunorubicin and Cytarabine With or Without Zosuquidar Trihydrochloride in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia or Refractory Anemia
4. Combination Chemotherapy, Interleukin-2, and Peripheral Stem Cell Transplantation in Treating Patients With Acute Myeloid Leukemia
5. Fludarabine and Busulfan Followed by Allogeneic Stem Cell Transplantation in Treating Older Patients With Acute Myeloid Leukemia in First Complete Remission
Related Studies:
Other adult acute monocytic leukemia Clinical Trials
Other California Clinical Trials
Other Stanford Clinical Trials
Tipifarnib in Treating Older Patients With Previously Untreated Acute Myeloid Leukemia
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