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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: | NCT00045396 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Leukemia Myelodysplastic Syndromes |
Drug: tipifarnib |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | A Phase II Study Of The Farnesyltransferase Inhibitor ZANESTRA (R115777, NSC #702818, IND #58,359) In Complete Remission Following Induction And/Or Consolidation Chemotherapy In Adults With Poor-Risk Acute Myelogenous Leukemia (AML) And High-Risk Myelodysplasia (MDS) |
| Estimated Enrollment: | 44 |
| Study Start Date: | August 2002 |
OBJECTIVES:
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed diagnosis of 1 of the following:
Poor-risk acute myeloid leukemia (AML), defined as any of the following:
High-risk myelodysplastic syndromes (MDS), defined as any of the following:
In early first complete remission after completing induction and consolidation chemotherapy
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Contacts and Locations| 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, New York | |
| James P. Wilmot Cancer Center at University of Rochester Medical Center | |
| Rochester, New York, United States, 14642 | |
| Study Chair: | Judith E. Karp, MD | Sidney Kimmel Comprehensive Cancer Center |
More Information
| Study ID Numbers: | CDR0000256885, JHOC-J0252, MSGCC-0150, NCI-5689 |
| Study First Received: | September 6, 2002 |
| Last Updated: | August 22, 2008 |
| ClinicalTrials.gov Identifier: | NCT00045396 History of Changes |
| Health Authority: | United States: Federal Government |
|
adult acute monocytic leukemia (M5b) adult acute erythroid leukemia (M6) adult acute megakaryoblastic leukemia (M7) adult acute minimally differentiated myeloid leukemia (M0) adult acute myeloblastic leukemia with maturation (M2) adult acute myeloblastic leukemia without maturation (M1) adult acute myeloid leukemia in remission adult acute myelomonocytic leukemia (M4) |
adult acute monoblastic leukemia (M5a) chronic myelomonocytic leukemia previously treated myelodysplastic syndromes refractory anemia with excess blasts refractory anemia with excess blasts in transformation secondary myelodysplastic syndromes adult acute myeloid leukemia with 11q23 (MLL) abnormalities |
|
Leukemia, Monocytic, Acute Chronic Myelomonocytic Leukemia Precancerous Conditions Acute Myelomonocytic Leukemia Acute Monoblastic Leukemia Leukemia, Myeloid, Acute Refractory Anemia Leukemia Preleukemia Acute Myelocytic Leukemia Acute Erythroblastic Leukemia Anemia, Refractory Acute Myeloid Leukemia, Adult |
Neoplasm Metastasis Congenital Abnormalities Tipifarnib Hematologic Diseases Leukemia, Myelomonocytic, Chronic Myelodysplastic Syndromes Anemia Leukemia, Myeloid Leukemia, Myelomonocytic, Acute Leukemia, Erythroblastic, Acute Anemia, Refractory, with Excess of Blasts Bone Marrow Diseases Di Guglielmo's Syndrome |
|
Neoplasms by Histologic Type Disease Precancerous Conditions Antineoplastic Agents Hematologic Diseases Myelodysplastic Syndromes Leukemia, Myeloid Leukemia, Myeloid, Acute Pharmacologic Actions |
Leukemia Preleukemia Neoplasms Pathologic Processes Therapeutic Uses Syndrome Bone Marrow Diseases Tipifarnib |