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Sponsors and Collaborators: |
University of Pennsylvania National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00568880 |
RATIONALE: Drugs used in chemotherapy, such as hydroxychloroquine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving hydroxychloroquine together with bortezomib may kill more cancer cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of hydroxychloroquine when given together with bortezomib and to see how well it works 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: hydroxychloroquine Procedure: biopsy Procedure: immunologic technique Procedure: laboratory biomarker analysis Procedure: mass spectrometry Procedure: pharmacological study |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase I/II Trial of Hydroxychloroquine Added to Bortezomib for Relapsed/Refractory Myeloma |
Estimated Enrollment: | 50 |
Study Start Date: | November 2007 |
Estimated Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a phase I dose-escalation study of hydroxychloroquine followed by a phase II study.
Blood and bone marrow samples are collected periodically during the study for correlative studies by mass spectrometry, proteasome inhibition assays, pharmacokinetic analysis and assessment of aggresome formation, autophagy inhibition, and apoptosis by protein electrophoresis and serum free light-chain analysis.
After completion of study treatment, patients are followed periodically.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Must meet 1 of the following criteria:
No known CNS involvement
PATIENT CHARACTERISTICS:
No known macular degeneration or retinopathy (diabetic or otherwise), porphyria, or psoriasis
No other conditions that would require therapy with hydroxychloroquine, including but not limited to, any of the following:
No concurrent or prior malignancy except for the following:
No uncontrolled intercurrent illness including, but not limited to, any of the following:
PRIOR CONCURRENT THERAPY:
United States, Pennsylvania | |
Abramson Cancer Center of the University of Pennsylvania | Recruiting |
Philadelphia, Pennsylvania, United States, 19104-4283 | |
Contact: Clinical Trials Office - Abramson Cancer Center of the Univers 800-474-9892 |
Study Chair: | Dan Vogl, MD | University of Pennsylvania |
Responsible Party: | Abramson Cancer Center of the University of Pennsylvania ( Dan Vogl ) |
Study ID Numbers: | CDR0000577505, UPCC-01407, UPCC-IRB-806149 |
Study First Received: | December 5, 2007 |
Last Updated: | December 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00568880 |
Health Authority: | Unspecified |
stage I multiple myeloma stage II multiple myeloma stage III multiple myeloma refractory multiple myeloma |
Immunoproliferative Disorders Blood Protein Disorders Hematologic Diseases Blood Coagulation Disorders Bortezomib Vascular Diseases Paraproteinemias |
Hemostatic Disorders Multiple Myeloma Hemorrhagic Disorders Multiple myeloma Hydroxychloroquine Lymphoproliferative Disorders Neoplasms, Plasma Cell |
Anti-Infective Agents Antiprotozoal Agents Neoplasms by Histologic Type Immune System Diseases Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Enzyme Inhibitors Pharmacologic Actions |
Protease Inhibitors Antimalarials Neoplasms Antiparasitic Agents Therapeutic Uses Cardiovascular Diseases Antirheumatic Agents |