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

Sponsor

CTI BioPharma (Industry)

Overall Status

Terminated

CT.gov ID

NCT00017069

Collaborator

National Cancer Institute (NCI) (NIH)

Locations

Actual Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Multiple Myeloma and Plasma Cell Neoplasm	Drug: arsenic trioxide Drug: dexamethasone	Phase 2

Detailed 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.

Study Design

Study Type:

Interventional

Masking:

None (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

Actual Study Start Date :

Feb 1, 2001

Actual Primary Completion Date :

Jan 1, 2005

Actual Study Completion Date :

Jan 1, 2005

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 120 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Arizona Clinical Research Center	Tucson	Arizona	United States	85712
2	Highlands Oncology Group - Springdale	Springdale	Arkansas	United States	72764
3	St. Joseph Hospital Regional Cancer Center - Orange	Orange	California	United States	92868-3849
4	Stockton Hematology Oncology Medical Group	Stockton	California	United States	95204
5	Rocky Mountain Cancer Centers - Midtown	Denver	Colorado	United States	80218
6	Pasco Pinellas Cancer Center - Tarpon Springs	Tarpon Springs	Florida	United States	34689
7	Winship Cancer Institute of Emory University	Atlanta	Georgia	United States	30322
8	Mountain States Tumor Institute - Boise	Meridian	Idaho	United States	83642
9	Memorial Sloan-Kettering Cancer Center	New York	New York	United States	10021
10	Texas Cancer Care	Fort Worth	Texas	United States	76104