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| Sponsor: | Cell Therapeutics |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00017069 |
Purpose
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: | Masking: Open Label Primary Purpose: Treatment |
| 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.
Eligibility| 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:
Contacts and Locations| 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 |
More Information
| 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 History of Changes |
| Health Authority: | United States: Federal Government |
|
refractory multiple myeloma stage II multiple myeloma stage III multiple myeloma |
|
Anti-Inflammatory Agents Dexamethasone Antineoplastic Agents Blood Protein Disorders Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Paraproteinemias Hemostatic Disorders Hormones Hemorrhagic Disorders Therapeutic Uses Cardiovascular Diseases Dexamethasone acetate Immunoproliferative Disorders |
Neoplasms by Histologic Type Antineoplastic Agents, Hormonal Immune System Diseases Hematologic Diseases Vascular Diseases Gastrointestinal Agents Arsenic trioxide Glucocorticoids Pharmacologic Actions Multiple Myeloma Neoplasms Autonomic Agents Peripheral Nervous System Agents Lymphoproliferative Disorders Central Nervous System Agents |