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 refractorystage II or stage III multiple myeloma.

Condition	Treatment or Intervention	Phase
refractory plasma cell neoplasm stage II multiple myeloma stage III multiple myeloma	Drug: arsenic trioxide  Drug: dexamethasone  Procedure: chemotherapy	Phase II

Further Study Details: 

OBJECTIVES:

• Determine the response rate of patients with recurrent or refractory stage II or III multiple myeloma treated with arsenic trioxide and dexamethasone.
• Determine the rates of overall and relapse-free survival in patients treated with this regimen.
• Determine the safety profile of this treatment regimen in these patients.

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 above,  Genders Eligible for Study:  Both

Criteria

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
• No more than 3 prior cytotoxic regimens
• No more than 1 prior high-dose cytotoxic regimen with stem cell transplantation
• 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:

• Over 18

Performance status:

• Karnofsky 70-100%

Life expectancy:

• At least 3 months

Hematopoietic:

• Absolute granulocyte count greater than 1,200/mm^3*
• Platelet count greater than 75,000/mm^3*
• Hemoglobin greater than 10 g/dL* NOTE: *Unless due to multiple myeloma

Hepatic:

• Bilirubin no greater than 2 times upper limit of normal (ULN)
• SGOT and SGPT no greater than 2 times ULN

Renal:

• Creatinine no greater than 1.5 times ULN

Cardiovascular:

• Absolute QT interval less than 460 msec in the presence of normal potassium and magnesium levels
• No significant underlying cardiac dysfunction
• No conduction defects
• No unstable angina
• No congestive heart failure
• No New York Heart Association class II-IV cardiac disease
• No myocardial infarction within the past 6 months

Other:

• No preexisting grade 2 or greater neurotoxicity/neuropathy
• No other malignancy within the past 5 years except curatively treated carcinoma in situ of the cervix or nonmelanoma skin cancer
• No uncontrolled diabetes mellitus
• No active serious infection uncontrolled by antibiotics
• No history of grand mal seizures (other than infantile febrile seizures)
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy:

• See Disease Characteristics
• See Chemotherapy
• At least 28 days since prior biologic therapy

Chemotherapy:

• See Disease Characteristics
• At least 28 days since prior cytotoxic chemotherapy, including high-dose cytotoxic regimen with stem cell transplantation
• No other concurrent cytotoxic chemotherapy

Endocrine therapy:

• See Disease Characteristics

Radiotherapy:

• At least 28 days since prior radiotherapy except for focal radiation for symptom control

Surgery:

• Not specified

Arizona
      Arizona Clinical Research Center, Tucson,  Arizona,  85712,  United States
Arkansas
      Highlands Oncology Group - Springdale, Springdale,  Arkansas,  72764,  United States
California
      St. Joseph Hospital Regional Cancer Center - Orange, Orange,  California,  92868-3849,  United States
      Stockton Hematology Oncology Medical Group, Stockton,  California,  95204,  United States
Colorado
      Rocky Mountain Cancer Centers - Midtown, Denver,  Colorado,  80218,  United States
Florida
      Pasco Pinellas Cancer Center - Tarpon Springs, Tarpon Springs,  Florida,  34689,  United States
Georgia
      Winship Cancer Institute of Emory University, Atlanta,  Georgia,  30322,  United States
Idaho
      Mountain States Tumor Institute - Boise, Meridian,  Idaho,  83642,  United States
New York
      Memorial Sloan-Kettering Cancer Center, New York,  New York,  10021,  United States
Texas
      Texas Cancer Care, Fort Worth,  Texas,  76104,  United States

Study chairs or principal investigators

Scott C. Stromatt, MD,  Study Chair,  Cell Therapeutics   

Study ID Numbers:  CDR0000068646; CTI-1060; MSKCC-01012; NCI-G01-1951
Record last reviewed:  June 2004
Last Updated:  October 13, 2004
Record first received:  June 6, 2001
ClinicalTrials.gov Identifier:  NCT00017069
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08