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| ID | Type | Description | Link |
|---|---|---|---|
| CDR0000068646 | Registry Identifier | PDQ (Physician Data Query) | |
| MSKCC-01012 | |||
| NCI-G01-1951 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| arsenic trioxide | Drug | |||
| dexamethasone | Drug |
DISEASE CHARACTERISTICS:
Diagnosis of stage II or III multiple myeloma
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
History of disease progression after prior steroid antimyeloma therapy
No smoldering myeloma
Measurable disease based on presence of serum and urine M protein and/or measurable plasmacytoma
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
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| Name | Affiliation | Role |
|---|---|---|
| Scott C. Stromatt, MD | CTI BioPharma | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Clinical Research Center | Tucson | Arizona | 85712 | United States | ||
| Highlands Oncology Group - Springdale |
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| Springdale |
| Arkansas |
| 72764 |
| United States |
| St. Joseph Hospital Regional Cancer Center - Orange | Orange | California | 92868-3849 | United States |
| Stockton Hematology Oncology Medical Group | Stockton | California | 95204 | United States |
| Rocky Mountain Cancer Centers - Midtown | Denver | Colorado | 80218 | United States |
| Pasco Pinellas Cancer Center - Tarpon Springs | Tarpon Springs | Florida | 34689 | United States |
| Winship Cancer Institute of Emory University | Atlanta | Georgia | 30322 | United States |
| Mountain States Tumor Institute - Boise | Meridian | Idaho | 83642 | United States |
| Memorial Sloan-Kettering Cancer Center | New York | New York | 10021 | United States |
| Texas Cancer Care | Fort Worth | Texas | 76104 | United States |
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| D054219 | Neoplasms, Plasma Cell |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000077237 | Arsenic Trioxide |
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D001152 | Arsenicals |
| D007287 | Inorganic Chemicals |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
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