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Sponsors and Collaborators: |
Cell Therapeutics National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00017069 |
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells.
PURPOSE: Phase II trial to study the effectiveness of combining arsenic trioxide and dexamethasone in treating patients who have recurrent or refractory stage II or stage III multiple myeloma.
Condition | Intervention | Phase |
---|---|---|
Multiple Myeloma and Plasma Cell Neoplasm |
Drug: arsenic trioxide Drug: dexamethasone |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | CTI 1060: A Phase II Clinical Trial of Arsenic Trioxide and Dexamethasone as Therapy for Relapsed or Refractory Multiple Myeloma |
Study Start Date: | February 2001 |
OBJECTIVES:
OUTLINE: Patients receive arsenic trioxide IV daily for 5 days during the first week only and then 2 days a week thereafter. Patients also receive IV or oral dexamethasone on days 1-4 every 4 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Disease assessments are conducted every 4 weeks. Patients achieving complete response (CR) receive 2 additional courses of therapy after initial determination of CR.
Final assessments are conducted 4 weeks after the last study treatment and then annually thereafter.
PROJECTED ACCRUAL: A total of 55 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:
Refractory myeloma defined as progressive disease (more than 25% increase in M protein or in radiographic findings of nonsecretory myeloma) despite up to 3 courses of prior cytotoxic chemotherapy
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
United States, Arizona | |
Arizona Clinical Research Center | |
Tucson, Arizona, United States, 85712 | |
United States, Arkansas | |
Highlands Oncology Group - Springdale | |
Springdale, Arkansas, United States, 72764 | |
United States, California | |
St. Joseph Hospital Regional Cancer Center - Orange | |
Orange, California, United States, 92868-3849 | |
Stockton Hematology Oncology Medical Group | |
Stockton, California, United States, 95204 | |
United States, Colorado | |
Rocky Mountain Cancer Centers - Midtown | |
Denver, Colorado, United States, 80218 | |
United States, Florida | |
Pasco Pinellas Cancer Center - Tarpon Springs | |
Tarpon Springs, Florida, United States, 34689 | |
United States, Georgia | |
Winship Cancer Institute of Emory University | |
Atlanta, Georgia, United States, 30322 | |
United States, Idaho | |
Mountain States Tumor Institute - Boise | |
Meridian, Idaho, United States, 83642 | |
United States, New York | |
Memorial Sloan-Kettering Cancer Center | |
New York, New York, United States, 10021 | |
United States, Texas | |
Texas Cancer Care | |
Fort Worth, Texas, United States, 76104 |
Study Chair: | Scott C. Stromatt, MD | Cell Therapeutics |
Study ID Numbers: | CDR0000068646, CTI-1060, MSKCC-01012, NCI-G01-1951 |
Study First Received: | June 6, 2001 |
Last Updated: | November 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00017069 |
Health Authority: | United States: Federal Government |
refractory multiple myeloma stage II multiple myeloma stage III multiple myeloma |
Dexamethasone Immunoproliferative Disorders Blood Protein Disorders Hematologic Diseases Blood Coagulation Disorders Vascular Diseases Arsenic trioxide Paraproteinemias |
Hemostatic Disorders Recurrence Multiple Myeloma Hemorrhagic Disorders Multiple myeloma Lymphoproliferative Disorders Dexamethasone acetate Neoplasms, Plasma Cell |
Anti-Inflammatory Agents Neoplasms by Histologic Type Antineoplastic Agents, Hormonal Immune System Diseases Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Gastrointestinal Agents Antiemetics |
Hormones Glucocorticoids Pharmacologic Actions Neoplasms Autonomic Agents Therapeutic Uses Cardiovascular Diseases Peripheral Nervous System Agents Central Nervous System Agents |