|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | Sidney Kimmel Comprehensive Cancer Center |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00027872 |
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 older patients who have previously untreated acute myeloid leukemia.
| Condition | Intervention | Phase |
|---|---|---|
|
Leukemia |
Drug: tipifarnib |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | A Phase II Study Of Farnesyl Transferase Inhibitor R115777 (NSC# 702818) In Previously Untreated Poor-Risk Acute Myeloid Leukemia |
| Study Start Date: | December 2001 |
| Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
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| Ages Eligible for Study: | 65 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed newly diagnosed acute myeloid leukemia (AML)
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, California | |
| Stanford Cancer Center at Stanford University Medical Center | |
| Stanford, California, United States, 94305-5750 | |
| United States, Georgia | |
| Blood and Marrow Transplant Group of Georgia | |
| Atlanta, Georgia, United States, 30342-4777 | |
| 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 | |
| United States, New York | |
| James P. Wilmot Cancer Center at University of Rochester Medical Center | |
| Rochester, New York, United States, 14642 | |
| New York Weill Cornell Cancer Center at Cornell University | |
| New York, New York, United States, 10021 | |
| Study Chair: | Judith E. Karp, MD | Sidney Kimmel Comprehensive Cancer Center |
More Information
| Study ID Numbers: | CDR0000069089, JHOC-J0255, MSGCC-U5400, MSGCC-0116, NCI-1754 |
| Study First Received: | December 7, 2001 |
| Last Updated: | January 23, 2009 |
| ClinicalTrials.gov Identifier: | NCT00027872 History of Changes |
| Health Authority: | United States: Federal Government |
|
untreated adult acute myeloid leukemia adult acute minimally differentiated myeloid leukemia (M0) adult acute myeloblastic leukemia without maturation (M1) adult acute myeloblastic leukemia with maturation (M2) adult acute myelomonocytic leukemia (M4) |
adult acute monocytic leukemia (M5b) adult acute monoblastic leukemia (M5a) adult acute erythroid leukemia (M6) adult acute megakaryoblastic leukemia (M7) adult acute myeloid leukemia with 11q23 (MLL) abnormalities |
|
Leukemia Neoplasms Neoplasms by Histologic Type Antineoplastic Agents Therapeutic Uses |
Leukemia, Myeloid Leukemia, Myeloid, Acute Pharmacologic Actions Tipifarnib |