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Sponsors and Collaborators: |
Sidney Kimmel Comprehensive Cancer Center National Cancer Institute (NCI) |
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00112853 |
RATIONALE: Tipifarnib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as etoposide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving tipifarnib together with etoposide may kill more cancer cells.
PURPOSE: This phase I trial is studying the side effects and best dose of tipifarnib and etoposide in treating older patients with newly diagnosed acute myeloid leukemia.
Condition | Intervention | Phase |
Leukemia |
Drug: etoposide Drug: tipifarnib |
Phase I |
MedlinePlus related topics: | Cancer |
ChemIDplus related topics: | Etoposide Etoposide phosphate Tipifarnib |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase I Trial of Oral Etoposide in Combination With the Farnesyltransferase Inhibitor R115777 (ZARNESTRA, Tipifarnib, NSC #702818, IND #58,359) in Elderly Adults With Newly Diagnosed Acute Myelogenous Leukemia (AML) |
Estimated Enrollment: | 100 |
Study Start Date: | March 2005 |
OBJECTIVES:
OUTLINE: This is a multicenter, dose-escalation study.
Patients receive oral tipifarnib twice daily on days 1-14 OR 1-21 and oral etoposide once daily on days 1-3 and 8-10. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients who achieve a complete response (CR) may receive up to 5 additional courses of therapy beyond documentation of CR.
Cohorts of 3-6 patients receive escalating doses of tipifarnib and etoposide until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Up to 14 additional patients receive treatment at the MTD.
After completion of study treatment, patients are followed at 1 month and then every 3 months thereafter.
PROJECTED ACCRUAL: A total of 3-100 patients will be accrued for this study.
Ages Eligible for Study: | 70 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed acute myeloid leukemia (AML), including the following subtypes:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
No active uncontrolled infection
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
United States, Florida | |||||
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida | |||||
Tampa, Florida, United States, 33612-9497 | |||||
United States, Georgia | |||||
Blood and Marrow Transplant Group of Georgia | |||||
Atlanta, Georgia, United States, 30342 | |||||
United States, Maryland | |||||
Greenebaum Cancer Center at University of Maryland Medical Center | |||||
Baltimore, Maryland, United States, 21201 | |||||
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | |||||
Baltimore, Maryland, United States, 21231-2410 | |||||
United States, Michigan | |||||
University of Michigan Comprehensive Cancer Center | |||||
Ann Arbor, Michigan, United States, 48109-0942 | |||||
United States, Minnesota | |||||
Mayo Clinic Cancer Center | |||||
Rochester, Minnesota, United States, 55905 | |||||
United States, New York | |||||
New York Weill Cornell Cancer Center at Cornell University | |||||
New York, New York, United States, 10021 |
Sidney Kimmel Comprehensive Cancer Center |
National Cancer Institute (NCI) |
Study Chair: | Judith E. Karp, MD | Sidney Kimmel Comprehensive Cancer Center |
Clinical trial summary from the National Cancer Institute's PDQ® database 
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Study ID Numbers: | CDR0000428305, JHOC-05020806, JHOC-J04110, NCI-6954 |
First Received: | June 2, 2005 |
Last Updated: | May 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00112853 |
Health Authority: | United States: Food and Drug Administration |
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