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

• Status: Terminated
• Trial end date: 2005-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: CTI BioPharma
• Collaborator: National Cancer Institute (NCI)
• Treatments: Arsenic Trioxide; BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate

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