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Sponsors and Collaborators: |
University of Maryland Greenebaum Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00310024 |
RATIONALE: Vorinostat and bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving vorinostat together with bortezomib may kill more cancer cells.
PURPOSE: This phase I trial is studying the side effects and best dose of vorinostat when given together with bortezomib 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: dexamethasone Drug: vorinostat |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase I Study of SAHA in Combination With Bortezomib in Relapsed and Refractory Multiple Myeloma |
Estimated Enrollment: | 40 |
Study Start Date: | November 2005 |
Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter, dose escalation study of vorinostat (SAHA).
Patients receive bortezomib IV on days 1, 4, 8, and 11 followed by oral SAHA twice daily on days 4-11. Beginning in course 3, some patients may receive low-dose oral dexamethasone on days 4-8. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of SAHA 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. An additional cohort of 10 patients receive treatment at the MTD.
Patients undergo blood collection and tumor biopsies periodically during study for pharmacologic and biomarker correlative studies.
After completion of study treatment, patients are followed at least once a month.
PROJECTED ACCRUAL: Approximately 40 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:
Histologically and clinically confirmed multiple myeloma
Measurable disease, defined by quantitative immunoglobulin levels in serum and/or urine and bone marrow plasmacytosis
PATIENT CHARACTERISTICS:
No uncontrolled current illness including, but not limited to, the following:
PRIOR CONCURRENT THERAPY:
United States, Maryland | |
Greenebaum Cancer Center at University of Maryland Medical Center | |
Baltimore, Maryland, United States, 21201-1592 | |
United States, New York | |
New York Weill Cornell Cancer Center at Cornell University | |
New York, New York, United States, 10021 |
Principal Investigator: | Ashraf Z. Badros, MD | University of Maryland Greenebaum Cancer Center |
Study ID Numbers: | CDR0000466109, MSGCC-GCC-0514, NCI-6835 |
Study First Received: | March 29, 2006 |
Last Updated: | November 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00310024 History of Changes |
Health Authority: | United States: Food and Drug Administration |
refractory multiple myeloma stage I multiple myeloma stage II multiple myeloma stage III multiple myeloma |
Anticarcinogenic Agents Dexamethasone Anti-Inflammatory Agents Blood Protein Disorders Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Paraproteinemias Hemostatic Disorders Hormones Hemorrhagic Disorders Anti-Inflammatory Agents, Non-Steroidal Analgesics Dexamethasone acetate Immunoproliferative Disorders |
Antineoplastic Agents, Hormonal Hematologic Diseases Blood Coagulation Disorders Vorinostat Bortezomib Vascular Diseases Glucocorticoids Protease Inhibitors Multiple Myeloma Analgesics, Non-Narcotic Peripheral Nervous System Agents Antirheumatic Agents Lymphoproliferative Disorders Neoplasms, Plasma Cell |
Anticarcinogenic Agents Anti-Inflammatory Agents Dexamethasone Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Blood Protein Disorders Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Paraproteinemias Hemostatic Disorders Hormones Hemorrhagic Disorders Sensory System Agents Therapeutic Uses |
Anti-Inflammatory Agents, Non-Steroidal Cardiovascular Diseases Analgesics Immunoproliferative Disorders Neoplasms by Histologic Type Antineoplastic Agents, Hormonal Immune System Diseases Hematologic Diseases Vorinostat Bortezomib Vascular Diseases Gastrointestinal Agents Enzyme Inhibitors Protective Agents Glucocorticoids |