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Sponsors and Collaborators: |
Mayo Clinic National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00719901 |
RATIONALE: Obatoclax and bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving obatoclax together with bortezomib may kill more cancer cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of obatoclax when given together with bortezomib and to see how well they work in treating patients with relapsed or refractory multiple myeloma.
Condition | Intervention | Phase |
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Multiple Myeloma and Plasma Cell Neoplasm |
Drug: bortezomib Drug: obatoclax mesylate |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase I/II Trial of Obatoclax Mesylate (GX15-070MS) in Combination With Bortezomib for the Treatment of Relapsed Multiple Myeloma |
Estimated Enrollment: | 62 |
Study Start Date: | July 2008 |
Estimated Primary Completion Date: | August 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter, phase I, dose-escalation study of obatoclax mesylate followed by a phase II study.
Patients receive obatoclax mesylate IV over 24 hours on days 1, 8, and 15 and bortezomib IV on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed monthly until disease progression and then every 6 months for up to 3 years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Symptomatic multiple myeloma, meeting the following criteria at original diagnosis:
Measurable disease as assessed by one of the following:
Previously treated with ≤ 10 courses (30 weeks) of bortezomib and had no disease progression during therapy OR completed bortezomib therapy within the past 6 weeks
No intracranial edema, intracranial metastasis, or active epidural disease
PATIENT CHARACTERISTICS:
No concurrent uncontrolled illness including, but not limited to the following:
PRIOR CONCURRENT THERAPY:
No other concurrent anticancer therapy
United States, Florida | |
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida | Recruiting |
Tampa, Florida, United States, 33612-9497 | |
Contact: Clinical Trials Office - H. Lee Moffitt Cancer Center and Rese 800-456-7121 canceranswers@moffitt.org | |
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, Minnesota | |
Mayo Clinic Cancer Center | Recruiting |
Rochester, Minnesota, United States, 55905 | |
Contact: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623 | |
Minnesota Oncology Hematology, PA - Minneapolis | Recruiting |
Minneapolis, Minnesota, United States, 55407 | |
Contact: Patrick J. Flynn, MD 612-863-8585 | |
United States, Missouri | |
Center for Cancer Care and Research | Recruiting |
Saint Louis, Missouri, United States, 63141 | |
Contact: John R. Eckardt, MD 314-628-1210 jeckardt@tcccr.com | |
United States, Tennessee | |
Vanderbilt-Ingram Cancer Center | Recruiting |
Nashville, Tennessee, United States, 37232-6838 | |
Contact: Clinical Trials Office - Vanderbilt-Ingram Cancer Center 800-811-8480 | |
United States, Wisconsin | |
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center | Recruiting |
Madison, Wisconsin, United States, 53792-6164 | |
Contact: Clinical Trials Office - University of Wisconsin Paul P. Carbo 608-262-5223 | |
Canada, Ontario | |
Princess Margaret Hospital | Recruiting |
Toronto, Ontario, Canada, M5G 2c1 | |
Contact: Suzanne M. Trudel 416-946-4566 suzanne.trudel@uhn.on.ca | |
Korea, Republic of | |
Yonsei Cancer Center at Yonsei University Medical Center | Recruiting |
Seoul, Korea, Republic of, 120-752 | |
Contact: Seung Tae Lee, MD 82-2-2228-1936 | |
Singapore | |
Cancer Institute at National University Hospital | Recruiting |
Singapore, Singapore, 119074 | |
Contact: Wee Joo Chng 65-6772-4823 | |
Johns Hopkins Singapore International Medical Centre | Recruiting |
Singapore, Singapore, 119074 | |
Contact: Wen-Son Hsieh 65-6871-8132 |
Study Chair: | A. Keith Stewart, MD | Mayo Clinic Scottsdale |
Study ID Numbers: | CDR0000597950, MAYO-MC068A |
Study First Received: | July 19, 2008 |
Last Updated: | December 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00719901 |
Health Authority: | Unspecified |
refractory multiple myeloma stage I multiple myeloma stage II multiple myeloma stage III multiple myeloma |
Immunoproliferative Disorders Blood Protein Disorders Hematologic Diseases Blood Coagulation Disorders Bortezomib Vascular Diseases Paraproteinemias |
Hemostatic Disorders Multiple Myeloma Hemorrhagic Disorders Multiple myeloma Lymphoproliferative Disorders Neoplasms, Plasma Cell |
Neoplasms Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Immune System Diseases Antineoplastic Agents |
Therapeutic Uses Enzyme Inhibitors Cardiovascular Diseases Pharmacologic Actions Protease Inhibitors |