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Sponsors and Collaborators: |
UNC Lineberger Comprehensive Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00744354 |
RATIONALE: Vorinostat and bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Bortezomib may also stop the growth of multiple myeloma by blocking blood flow to the tumor.
Drugs used in chemotherapy, such as doxorubicin hydrochloride liposome, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving doxorubicin hydrochloride liposome together with vorinostat and bortezomib may kill more cancer cells.
PURPOSE: This phase I trial is studying the side effects and best dose of vorinostat and to see how well it works when given together with bortezomib and doxorubicin hydrochloride liposome 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: pegylated liposomal doxorubicin hydrochloride Drug: vorinostat |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label |
Official Title: | A Phase 1 Dose Escalation Study of Bortezomib (Velcade®), Pegylated Liposomal Doxorubicin (Doxil®), and Vorinostat (Suberoylanilide Hydromaxic Acid, Saha, Zolinzatm) in Patients With Relapse/Refractory Multiple Myeloma |
Estimated Enrollment: | 42 |
Study Start Date: | October 2008 |
Estimated Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter, dose escalation study of vorinostat.
Patients receive oral vorinostat once daily on days 1-14, bortezomib IV on days 1, 4, 8, and 11, and pegylated liposomal doxorubicin hydrochloride IV on day 4. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Blood samples are collected periodically for proteasome inhibition assays and acetylated alpha-tubulin studies.
After completion of study treatment, patients are followed at 1 and 3 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of multiple myeloma
PATIENT CHARACTERISTICS:
Patients must have adequate cardiovascular function, defined by all of the following:
PRIOR CONCURRENT THERAPY:
Prior allogeneic stem cell or bone marrow transplantation allowed provided the following criteria are met:
United States, North Carolina | |
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill | Recruiting |
Chapel Hill, North Carolina, United States, 27599-7295 | |
Contact: Clinical Trials Office - Lineberger Comprehensive Cancer Cente 877-668-0683; 919-966-4432 | |
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 |
Principal Investigator: | Peter Voorhees, MD | UNC Lineberger Comprehensive Cancer Center |
Responsible Party: | Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill ( Peter Voorhees ) |
Study ID Numbers: | CDR0000612431, UNC-LCCC0715, ORTHO-UNC-LCCC0715 |
Study First Received: | August 29, 2008 |
Last Updated: | July 8, 2009 |
ClinicalTrials.gov Identifier: | NCT00744354 History of Changes |
Health Authority: | Unspecified |
refractory multiple myeloma stage I multiple myeloma stage II multiple myeloma stage III multiple myeloma |
Anticarcinogenic Agents Anti-Inflammatory Agents Immunoproliferative Disorders Blood Protein Disorders Hematologic Diseases Blood Coagulation Disorders Bortezomib Vorinostat Vascular Diseases Paraproteinemias Hemostatic Disorders Doxorubicin |
Protease Inhibitors Multiple Myeloma Anti-Bacterial Agents Hemorrhagic Disorders Analgesics, Non-Narcotic Anti-Inflammatory Agents, Non-Steroidal Peripheral Nervous System Agents Analgesics Antirheumatic Agents Lymphoproliferative Disorders Neoplasms, Plasma Cell |
Anticarcinogenic Agents Anti-Inflammatory Agents Molecular Mechanisms of Pharmacological Action Blood Protein Disorders Antineoplastic Agents Physiological Effects of Drugs Paraproteinemias Hemostatic Disorders Antibiotics, Antineoplastic Hemorrhagic Disorders Sensory System Agents Therapeutic Uses Cardiovascular Diseases Anti-Inflammatory Agents, Non-Steroidal Analgesics |
Immunoproliferative Disorders Neoplasms by Histologic Type Immune System Diseases Hematologic Diseases Vorinostat Bortezomib Vascular Diseases Enzyme Inhibitors Protective Agents Doxorubicin Pharmacologic Actions Protease Inhibitors Multiple Myeloma Neoplasms Analgesics, Non-Narcotic |