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

Multiple Myeloma and Plasma Cell Neoplasm Clinical Trial

Official title:

CTI 1060: A Phase II Clinical Trial of Arsenic Trioxide and Dexamethasone as Therapy for Relapsed or Refractory Multiple Myeloma

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00017069
• Other study ID #: CTI-1060
• Secondary ID: CDR0000068646MSK
• Status: Terminated
• Phase: Phase 2
• Start date: February 2001
• Est. completion date: January 2005

Study information

• Verified date: October 2020
• Source: CTI BioPharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 0
• Est. completion date: January 2005
• Est. primary completion date: January 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Myeloma
• Multiple Myeloma and Plasma Cell Neoplasm
• Neoplasms, Plasma Cell
• Plasmacytoma

Intervention

Drug:
• arsenic trioxide

• dexamethasone

Locations

Country	Name	City	State
United States	Winship Cancer Institute of Emory University	Atlanta	Georgia
United States	Rocky Mountain Cancer Centers - Midtown	Denver	Colorado
United States	Texas Cancer Care	Fort Worth	Texas
United States	Mountain States Tumor Institute - Boise	Meridian	Idaho
United States	Memorial Sloan-Kettering Cancer Center	New York	New York
United States	St. Joseph Hospital Regional Cancer Center - Orange	Orange	California
United States	Highlands Oncology Group - Springdale	Springdale	Arkansas
United States	Stockton Hematology Oncology Medical Group	Stockton	California
United States	Pasco Pinellas Cancer Center - Tarpon Springs	Tarpon Springs	Florida
United States	Arizona Clinical Research Center	Tucson	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
CTI BioPharma	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,