|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | Fred Hutchinson Cancer Research Center |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00673153 |
Purpose
RATIONALE: Vorinostat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as gemtuzumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving vorinostat together with gemtuzumab may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving vorinostat together with gemtuzumab works in treating older patients with previously untreated acute myeloid leukemia.
| Condition | Intervention | Phase |
|---|---|---|
|
Leukemia |
Drug: gemtuzumab ozogamicin Drug: vorinostat |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label |
| Official Title: | Phase II Trial of Vorinostat (Suberoylanilide Hydroxamic Acid or SAHA; Zolinza™) in Combination With Gemtuzumab Ozogamicin (Mylotarg™) as Induction and Post-Remission Therapy in Older Patients With Previously Untreated Non-M3 Acute Myeloid Leukemia |
| Estimated Enrollment: | 107 |
| Study Start Date: | March 2008 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study. Patients are stratified according to risk status (good risk [60-69 years of age OR ECOG/WHO/ZUBROD performance status (PS) 0-1] vs poor risk [≥ 70 years of age AND ECOG/WHO/ZUBROD PS 2-3]).
After completion of study treatment, patients are followed periodically.
Eligibility| Ages Eligible for Study: | 60 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Morphological diagnosis of acute myeloid leukemia (AML)
Must have cytogenetic analysis performed on bone marrow specimen
Patients with a history of antecedent myelodysplastic syndrome (MDS) are eligible, if prior treatment did not include intensive chemotherapy AND patients are off therapy for ≥ 30 days prior to study registration and recovered
PATIENT CHARACTERISTICS:
WBC < 10,000/μL
No other malignancy unless the patient was diagnosed ≥ 2 years ago AND has been disease-free for ≥ 6 months following completion of curative intent therapy
PRIOR CONCURRENT THERAPY:
Contacts and Locations| United States, California | |
| Stanford Cancer Center | Recruiting |
| Stanford, California, United States, 94305-5824 | |
| Contact: Clinical Trials Office - Stanford Cancer Center 650-498-7061 cctoffice@stanford.edu | |
| United States, Illinois | |
| Robert H. Lurie Comprehensive Cancer Center at Northwestern University | Recruiting |
| Chicago, Illinois, United States, 60611-3013 | |
| Contact: Clinical Trials Office - Robert H. Lurie Comprehensive Cancer 312-695-1301 cancer@northwestern.edu | |
| United States, Michigan | |
| Barbara Ann Karmanos Cancer Institute | Recruiting |
| Detroit, Michigan, United States, 48201-1379 | |
| Contact: Clinical Trials Office - Barbara Ann Karmanos Cancer Institute 313-576-9363 | |
| United States, North Carolina | |
| 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 | |
| United States, Texas | |
| M. D. Anderson Cancer Center at University of Texas | Recruiting |
| Houston, Texas, United States, 77030-4009 | |
| Contact: Clinical Trials Office - M. D. Anderson Cancer Center at the U 713-792-3245 | |
| United States, Washington | |
| Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | Recruiting |
| Seattle, Washington, United States, 98109-1024 | |
| Contact: Roland Walter, MD, PhD 800-804-8824 | |
| Seattle Cancer Care Alliance | Recruiting |
| Seattle, Washington, United States, 98109-1023 | |
| Contact: Clinical Trials Office - Seattle Cancer Care Alliance 800-804-8824 | |
| Veterans Affairs Medical Center - Seattle | Recruiting |
| Seattle, Washington, United States, 98108 | |
| Contact: William H. Schubach, MD 206-764-2265 | |
| Principal Investigator: | Roland Walter, MD, PhD | Fred Hutchinson Cancer Research Center |
More Information
| Responsible Party: | Fred Hutchinson Cancer Research Center ( Roland Walter ) |
| Study ID Numbers: | CDR0000595176, FHCRC-2200.00, IR-6688, MERCK-FHCRC-2200.00 |
| Study First Received: | May 6, 2008 |
| Last Updated: | November 13, 2009 |
| ClinicalTrials.gov Identifier: | NCT00673153 History of Changes |
| 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) 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) untreated adult acute myeloid leukemia adult acute minimally differentiated myeloid leukemia (M0) secondary acute myeloid leukemia |
|
Anti-Inflammatory Agents Anticarcinogenic Agents Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Leukemia, Myeloid, Acute Antibodies, Monoclonal Leukemia Sensory System Agents Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Analgesics |
Neoplasms by Histologic Type Vorinostat Enzyme Inhibitors Leukemia, Myeloid Gemtuzumab Protective Agents Pharmacologic Actions Neoplasms Analgesics, Non-Narcotic Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents |