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Sponsored by: |
The Cleveland Clinic |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00112879 |
RATIONALE: Drugs used in chemotherapy, such as arsenic trioxide and dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Thalidomide may stop the growth of multiple myeloma by blocking blood flow to the cancer. Giving arsenic trioxide together with ascorbic acid, dexamethasone, and thalidomide may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving arsenic trioxide together with ascorbic acid, dexamethasone, and thalidomide work in treating patients with multiple myeloma.
Condition | Intervention | Phase |
---|---|---|
Stage I Multiple Myeloma Stage II Multiple Myeloma Stage III Multiple Myeloma Refractory Plasma Cell Neoplasm |
Drug: arsenic trioxide Drug: ascorbic acid Drug: dexamethasone Drug: thalidomide Procedure: anti-cytokine therapy Procedure: antiangiogenesis therapy Procedure: biological therapy Procedure: chemotherapy Procedure: drug resistance inhibition Procedure: growth factor antagonist therapy Procedure: non-specific immune-modulator therapy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Phase II Study of Arsenic Trioxide, Ascorbic Acid, Dexamethasone, and Thalidomide in Patients With Previously Untreated High-Risk or Relapsed or Refractory Multiple Myeloma |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is an open-label study.
After completion of study treatment, patients are followed at 4 weeks and then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 33-68 patients (15-34 with previously untreated high-risk multiple myeloma [MM] and 18-34 with relapsed or refractory MM) 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:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
United States, Ohio | |
Cleveland Clinic Taussig Cancer Center | |
Cleveland, Ohio, United States, 44195 |
Study Chair: | Mohamad A. Hussein, MD | The Cleveland Clinic |
Study ID Numbers: | CDR0000428248, CCF-IRB-7469, CCF-IRB-5241, CCF-CTI-T12016 |
Study First Received: | June 2, 2005 |
Last Updated: | December 4, 2006 |
ClinicalTrials.gov Identifier: | NCT00112879 |
Health Authority: | United States: Federal Government |
Dexamethasone Immunoproliferative Disorders Thalidomide Blood Protein Disorders Hematologic Diseases Blood Coagulation Disorders Vascular Diseases Arsenic trioxide Paraproteinemias |
Hemostatic Disorders Multiple Myeloma Hemorrhagic Disorders Multiple myeloma Lymphoproliferative Disorders Dexamethasone acetate Ascorbic Acid Neoplasms, Plasma Cell |
Anti-Inflammatory Agents Anti-Infective Agents Antioxidants Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Hormones Anti-Bacterial Agents Vitamins Therapeutic Uses Cardiovascular Diseases Growth Inhibitors |
Angiogenesis Modulating Agents Micronutrients Neoplasms by Histologic Type Immune System Diseases Antineoplastic Agents, Hormonal Growth Substances Gastrointestinal Agents Angiogenesis Inhibitors Protective Agents Glucocorticoids Immunosuppressive Agents Pharmacologic Actions Neoplasms Autonomic Agents Peripheral Nervous System Agents |