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Sponsored by: |
Barbara Ann Karmanos Cancer Institute |
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00258245 |
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. Ascorbic acid may help arsenic trioxide work better by making cancer cells more sensitive to the drug. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Thalidomide may stop the growth of cancer cells by stopping blood flow to the cancer. Giving arsenic trioxide and ascorbic acid together with bortezomib, thalidomide, and dexamethasone may stop the growth of and kill more cancer cells.
PURPOSE: This phase I trial is studying the side effects and best dose of arsenic trioxide when given together with ascorbic acid, bortezomib, thalidomide, and dexamethasone in treating patients with relapsed or refractory multiple myeloma or plasma cell leukemia.
Condition | Intervention | Phase |
Multiple Myeloma and Plasma Cell Neoplasm |
Drug: arsenic trioxide Drug: ascorbic acid Drug: bortezomib Drug: dexamethasone Drug: thalidomide |
Phase I |
Genetics Home Reference related topics: | aceruloplasminemia hemophilia |
MedlinePlus related topics: | Arsenic Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Multiple Myeloma |
ChemIDplus related topics: | Dexamethasone Dexamethasone acetate Dexamethasone Sodium Phosphate Doxiproct plus Thalidomide Arsenic trioxide Bortezomib Ascorbic acid |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase I Study of Arsenic Trioxide and Ascorbic Acid (ATO/AA) in Combination With Low Dose Veclade-Thalidomide-Dexamethasone (VTD) in Relapsed/Refractory Multiple Myeloma (MM) |
Estimated Enrollment: | 24 |
Study Start Date: | May 2005 |
Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
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 determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
PROJECTED ACCRUAL: A total of 24 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 confirmed multiple myeloma (MM) or plasma cell leukemia meeting 1 of the following criteria:
Measurable disease, defined by 1 of the following:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
No history of heparin-induced thrombocytopenia
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
More than 4 weeks since prior therapeutic radiotherapy (e.g., to plasmacytomas)
Surgery
Other
United States, Michigan | |||||
Barbara Ann Karmanos Cancer Institute | |||||
Detroit, Michigan, United States, 48201-1379 |
Barbara Ann Karmanos Cancer Institute |
Study Chair: | Jeffrey A. Zonder, MD | Barbara Ann Karmanos Cancer Institute |
Clinical trial summary from the National Cancer Institute's PDQ® database 
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Study ID Numbers: | CDR0000445464, WSU-D-2869, WSU-HIC-01705M1F |
First Received: | November 22, 2005 |
Last Updated: | September 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00258245 |
Health Authority: | United States: Federal Government |
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