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Sponsors and Collaborators: |
Sylvester Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00006021 |
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Vitamin C may increase the effectiveness of arsenic trioxide by making cancer cells more sensitive to the drug.
PURPOSE: Phase I/II trial to determine the effectiveness of arsenic trioxide plus vitamin C in treating patients who have recurrent or refractory multiple myeloma.
Condition | Intervention | Phase |
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Multiple Myeloma and Plasma Cell Neoplasm |
Dietary Supplement: ascorbic acid Drug: arsenic trioxide |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Phase I/II Trial of Arsenic Trioxide (As2O3) With Ascorbic Acid in the Treatment of Relapsed/Refractory Multiple Myeloma |
Estimated Enrollment: | 43 |
Study Start Date: | June 2000 |
OBJECTIVES:
OUTLINE: This is a multicenter, dose-escalation study of arsenic trioxide.
Cohorts of 3-6 patients receive escalating doses of arsenic trioxide until the maximum tolerated dose (MTD) is reached. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
Patients are followed monthly for up to 5 years.
PROJECTED ACCRUAL: A total of 31-43 patients (6-18 for phase I and 16-25 for phase II) will be accrued for this study within 2.5 years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed multiple myeloma
Refractory or chemoresistant disease defined as failure to respond (less than 50% reduction in M protein level) or progression within 2 months after receiving at least 2 chemotherapy regimens including:
Plateau phase defined as M protein in the serum or urine for more than 6 weeks despite response to prior therapy
Recurrent disease defined as progression more than 2 months after initial therapy and failure to respond (less than 50% reduction or progression in M protein levels) to 1 chemotherapy regimen listed above or other salvage regimens (e.g., high-dose cyclophosphamide or topotecan)
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, Florida | |
Baptist-South Miami Regional Cancer Program | |
Miami, Florida, United States, 33176-2197 | |
Cedars Medical Center | |
Miami, Florida, United States, 33136 | |
Mount Sinai Comprehensive Cancer Center at Mount Sinai Medical Center | |
Miami Beach, Florida, United States, 33140 | |
University of Miami Sylvester Comprehensive Cancer Center | |
Miami, Florida, United States, 33136 |
Study Chair: | Kelvin Lee, MD | Sylvester Cancer Center |
Study ID Numbers: | CDR0000068033, SCCC-20010, SCCC-NCI-43, NCI-43 |
Study First Received: | July 5, 2000 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00006021 History of Changes |
Health Authority: | United States: Federal Government |
refractory multiple myeloma stage II multiple myeloma stage III multiple myeloma |
Antioxidants Immunoproliferative Disorders Blood Protein Disorders Hematologic Diseases Blood Coagulation Disorders Vascular Diseases Arsenic trioxide Trace Elements Paraproteinemias |
Hemostatic Disorders Recurrence Multiple Myeloma Hemorrhagic Disorders Vitamins Micronutrients Lymphoproliferative Disorders Ascorbic Acid Neoplasms, Plasma Cell |
Antioxidants Molecular Mechanisms of Pharmacological Action Blood Protein Disorders Antineoplastic Agents Physiological Effects of Drugs Paraproteinemias Hemostatic Disorders Hemorrhagic Disorders Therapeutic Uses Vitamins Cardiovascular Diseases Micronutrients Immunoproliferative Disorders |
Neoplasms by Histologic Type Immune System Diseases Hematologic Diseases Growth Substances Vascular Diseases Arsenic trioxide Protective Agents Pharmacologic Actions Multiple Myeloma Neoplasms Lymphoproliferative Disorders Ascorbic Acid Neoplasms, Plasma Cell |