Multiple Myeloma Clinical Trial

Arsenic Trioxide and Dexamethasone in Treating Patients With Recurrent or Refractory Stage II or Stage III Multiple Myeloma

Summary

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.

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Full Description

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.

View Eligibility Criteria

Eligibility 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

Study is for people with:

Multiple Myeloma

Phase:

Phase 2

Study ID:

NCT00017069

Recruitment Status:

Terminated

Sponsor:

CTI BioPharma

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There are 10 Locations for this study

See Locations Near You

Arizona Clinical Research Center
Tucson Arizona, 85712, United States
Highlands Oncology Group - Springdale
Springdale Arkansas, 72764, United States
St. Joseph Hospital Regional Cancer Center - Orange
Orange California, 92868, 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

How clear is this clinincal trial information?

Study is for people with:

Multiple Myeloma

Phase:

Phase 2

Study ID:

NCT00017069

Recruitment Status:

Terminated

Sponsor:


CTI BioPharma

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