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Sponsors and Collaborators: |
Cancer and Leukemia Group B National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00742625 |
RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as daunorubicin and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving bortezomib together with combination chemotherapy may kill more cancer cells.
PURPOSE: This phase II trial is studying the side effects and best dose of bortezomib when given together with daunorubicin and cytarabine and to see how well it works in treating older patients with previously untreated acute myeloid leukemia.
Condition | Intervention | Phase |
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Leukemia |
Drug: bortezomib Drug: cytarabine Drug: daunorubicin hydrochloride |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Dose Escalation and Phase II Study of Bortezomib (IND #58443, NSC # 681239) Added to Standard Daunorubicin and Cytarabine Therapy for Patients With Previously Untreated Acute Myeloid Leukemia Age 60-75 Years |
Estimated Enrollment: | 88 |
Study Start Date: | September 2008 |
Estimated Primary Completion Date: | July 2013 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter, dose-escalation study of bortezomib. Doses of bortezomib are escalated during remission consolidation therapy.
Remission induction therapy:
After completion of remission induction course 1, patients undergo bone marrow aspiration and biopsy for evaluation of response. Patients achieving a complete response (CR) or partial response (PR) proceed to remission consolidation therapy. Patients achieving a CR with incomplete platelet recovery (CRp) proceed to remission consolidation therapy after platelet counts recover. Patients with persistent leukemia (≥ 20% bone marrow cellularity and ≥ 5% bone marrow myeloblasts) proceed to remission induction course 2.
After completion of remission induction course 2, patients undergo bone marrow aspiration and biopsy for evaluation of response. Patients achieving a CR or PR proceed to remission consolidation therapy. Patients achieving a CRp proceed to remission consolidation therapy after platelet counts recover. Patients with residual leukemia who do not meet the criteria for PR are removed from the study.
After completion of study therapy, patients are followed every 2 months for 2 years, every 3 months for 2 years, and then annually for up to 10 years.
Ages Eligible for Study: | 60 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Unequivocally histologically confirmed acute myeloid leukemia (AML)
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
No prior therapy for leukemia or pre-leukemic disorders, except for the following:
No other concurrent chemotherapy, except for the following:
United States, Delaware | |
CCOP - Christiana Care Health Services | Recruiting |
Newark, Delaware, United States, 19713 | |
Contact: Clinical Trial Office - CCOP - Christiana Care Health Services 302-733-6227 | |
Tunnell Cancer Center at Beebe Medical Center | Recruiting |
Lewes, Delaware, United States, 19958 | |
Contact: Clinical Trials Office - Tunnell Cancer Center 302-645-3171 | |
United States, Florida | |
Florida Hospital Cancer Institute at Florida Hospital Orlando | Recruiting |
Orlando, Florida, United States, 32803-1273 | |
Contact: Clinical Trials Office - Florida Hospital Cancer Institute 407-303-5623 | |
United States, Maryland | |
Union Hospital Cancer Program at Union Hospital | Recruiting |
Elkton MD, Maryland, United States, 21921 | |
Contact: Stephen S. Grubbs, MD 302-366-1200 | |
United States, New Jersey | |
Cancer Institute of New Jersey at Cooper - Voorhees | Recruiting |
Voorhees, New Jersey, United States, 08043 | |
Contact: Clinical Trials Office - Cancer Institute of New Jersey at Coo 856-325-6757 | |
United States, New York | |
CCOP - North Shore University Hospital | Recruiting |
Manhasset, New York, United States, 11030 | |
Contact: Jonathan E. Kolitz, MD 516-562-8970 | |
Don Monti Comprehensive Cancer Center at North Shore University Hospital | Recruiting |
Manhasset, New York, United States, 11030 | |
Contact: Clinical Trials Office - Don Monti Comprehensive Cancer Center 516-734-8900 | |
Long Island Jewish Medical Center | Recruiting |
New Hyde Park, New York, United States, 11042 | |
Contact: Jonathan E. Kolitz, MD 516-562-8970 | |
Monter Cancer Center of the North Shore-LIJ Health System | Recruiting |
Lake Success, New York, United States, 11042 | |
Contact: Jonathan E. Kolitz, MD 516-562-8970 | |
Roswell Park Cancer Institute | Recruiting |
Buffalo, New York, United States, 14263-0001 | |
Contact: Clinical Trials Office - Roswell Park Cancer Institute 877-275-7724 | |
United States, North Carolina | |
Kinston Medical Specialists | Recruiting |
Kinston, North Carolina, United States, 28501 | |
Contact: Peter R. Watson, MD 252-559-2200ext.201 | |
Wake Forest University Comprehensive Cancer Center | Recruiting |
Winston-Salem, North Carolina, United States, 27157-1096 | |
Contact: Clinical Trials Office - Wake Forest University Comprehensive 336-713-6771 | |
Wayne Memorial Hospital, Incorporated | Recruiting |
Goldsboro, North Carolina, United States, 27534 | |
Contact: James N. Atkins, MD 919-580-0000 | |
United States, Ohio | |
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center | Recruiting |
Columbus, Ohio, United States, 43210-1240 | |
Contact: Clinical Trials Office - OSU Comprehensive Cancer Center 614-293-4976 osu@emergingmed.com |
Study Chair: | Eyal C. Attar, MD | Massachusetts General Hospital |
Study ID Numbers: | CDR0000612758, CALGB-10502 |
Study First Received: | August 27, 2008 |
Last Updated: | January 10, 2009 |
ClinicalTrials.gov Identifier: | NCT00742625 |
Health Authority: | Unspecified |
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) 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 monoblastic leukemia (M5a) adult acute monocytic leukemia (M5b) adult erythroleukemia (M6a) adult pure erythroid leukemia (M6b) adult acute megakaryoblastic leukemia (M7) |
Leukemia, Monocytic, Acute Daunorubicin Bortezomib Acute myelogenous leukemia Acute myelomonocytic leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Di Guglielmo's syndrome Leukemia, Myelomonocytic, Acute |
Leukemia Leukemia, Erythroblastic, Acute Acute erythroblastic leukemia Acute myeloid leukemia, adult Congenital Abnormalities Acute myelocytic leukemia Acute monoblastic leukemia Cytarabine |
Antimetabolites Anti-Infective Agents Neoplasms by Histologic Type Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs |
Enzyme Inhibitors Antibiotics, Antineoplastic Antiviral Agents Immunosuppressive Agents Pharmacologic Actions Protease Inhibitors Neoplasms Therapeutic Uses |