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Sponsors and Collaborators: |
H. Lee Moffitt Cancer Center and Research Institute National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00383474 |
RATIONALE: Tipifarnib and bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving tipifarnib together with bortezomib may kill more cancer cells.
PURPOSE: This phase I trial is studying the side effects and best dose of tipifarnib and bortezomib in treating patients with acute leukemia or chronic myelogenous leukemia in blast phase.
Condition | Intervention | Phase |
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Leukemia |
Drug: bortezomib Drug: tipifarnib Genetic: protein expression analysis Other: immunohistochemistry staining method Procedure: biopsy |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase I Dose-Escalation Study of R115777 (Tipifarnib) Plus PS-341 (Bortezomib) in Relapsed or Refractory Acute Leukemias |
Estimated Enrollment: | 35 |
Study Start Date: | October 2006 |
Estimated Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a dose-escalation study.
Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11 and oral tipifarnib twice daily on days 1-14. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients with partial response or stable disease may continue therapy beyond 6 courses at the discretion of the investigator.
Cohorts of 3-6 patients receive escalating doses of bortezomib and tipifarnib 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.
Blood is collected periodically for protein expression studies. Bone marrow aspirates obtained at baseline are examined by immunohistochemistry for Ki-67 activity.
PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Pathologically confirmed diagnosis of 1 of the following:
Meets 1 of the following disease-specific criteria:
PATIENT CHARACTERISTICS:
Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
United States, Florida | |
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida | Recruiting |
Tampa, Florida, United States, 33612 | |
Contact: Jeffrey E. Lancet, MD 813-745-6841 | |
United States, Georgia | |
Winship Cancer Institute of Emory University | Recruiting |
Atlanta, Georgia, United States, 30322 | |
Contact: Bonita Feinstein, RN 404-778-4994 | |
United States, South Carolina | |
Hollings Cancer Center at Medical University of South Carolina | Recruiting |
Charleston, South Carolina, United States, 29425 | |
Contact: Robert K. Stuart, MD 843-792-4271 |
Study Chair: | Jeffrey E. Lancet, MD | H. Lee Moffitt Cancer Center and Research Institute |
Study ID Numbers: | CDR0000502258, MCC-14796, NCI-7306 |
Study First Received: | September 29, 2006 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00383474 History of Changes |
Health Authority: | Unspecified |
recurrent adult acute lymphoblastic leukemia recurrent adult acute myeloid leukemia blastic phase chronic myelogenous leukemia relapsing chronic myelogenous leukemia untreated adult acute lymphoblastic leukemia untreated adult acute myeloid leukemia adult acute basophilic leukemia adult acute eosinophilic leukemia adult erythroleukemia (M6a) adult pure erythroid leukemia (M6b) adult acute megakaryoblastic leukemia (M7) |
adult acute minimally differentiated myeloid leukemia (M0) adult acute myelomonocytic leukemia (M4) adult acute monoblastic leukemia (M5a) adult acute monocytic leukemia (M5b) adult acute myeloblastic leukemia with maturation (M2) adult acute myeloblastic leukemia without maturation (M1) adult acute myeloid leukemia with 11q23 (MLL) abnormalities adult acute myeloid leukemia with inv(16)(p13;q22) adult acute myeloid leukemia with t(16;16)(p13;q22) adult acute myeloid leukemia with t(8;21)(q22;q22) |
Leukemia, Monocytic, Acute Blast Crisis Leukemia, Lymphoid Acute Myelomonocytic Leukemia Acute Monoblastic Leukemia Leukemia, Myeloid, Acute Leukemia Acute Myelocytic Leukemia Acute Erythroblastic Leukemia Acute Myeloid Leukemia, Adult Congenital Abnormalities Acute Lymphoblastic Leukemia Tipifarnib |
Precursor Cell Lymphoblastic Leukemia-Lymphoma Hematologic Diseases Bortezomib Myeloproliferative Disorders Leukemia, Myeloid Recurrence Protease Inhibitors Leukemia, Myelomonocytic, Acute Leukemia, Erythroblastic, Acute Leukemia, Myelogenous, Chronic, BCR-ABL Positive Chronic Myelogenous Leukemia Bone Marrow Diseases Di Guglielmo's Syndrome |
Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Hematologic Diseases Antineoplastic Agents Bortezomib Myeloproliferative Disorders Enzyme Inhibitors Leukemia, Myeloid |
Pharmacologic Actions Protease Inhibitors Leukemia Neoplasms Therapeutic Uses Leukemia, Myelogenous, Chronic, BCR-ABL Positive Bone Marrow Diseases Tipifarnib |