Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Completed	18 and over	NCI	CWRCC-ICC-1A92 NCI-T92-0161D, T92-0161

Objectives

I.  Determine the efficacy of interleukin-4 (IL-4) in patients with relapsed 
or refractory multiple myeloma.

II.  Determine the toxicity of IL-4 in these patients.

III.  Measure the effect of IL-4 on serum levels of IL-6 in these patients.

IV.  Measure IL-6 production in short-term cultures of peripheral blood 
monocytes isolated from these patients before and during treatment with IL-4.

V.  Determine whether a correlation exists between changes in serum levels of 
IL-6 or IL-6 production by peripheral blood monocytes and tumor response in 
patients with multiple myeloma.

VI.  Measure the effect of in vitro IL-4 on IL-6 production in peripheral 
blood monocytes, and determine whether this in vitro assay is predictive of 
the clinical response to IL-4.

Entry Criteria

Disease Characteristics:

Multiple myeloma that has relapsed or failed at least 1 trial
of standard chemotherapy

Measurable or evaluable disease (assessed within 2 weeks prior
to entry) required, and defined as:
  Quantitative monoclonal immunoglobulins in serum or urine
  Plasmacytomas
  Bone marrow plasmacytosis at least 10% (without a monoclonal
     immunoglobulin spike)
  Lytic bone lesions

No prior or current meningeal carcinomatosis

No prior or current brain metastases

Prior/Concurrent Therapy:

Biologic therapy:
  No prior biologic therapy except interferon alpha
  At least 4 weeks since biologic therapy

Chemotherapy:
  At least 4 weeks since chemotherapy (at least 6 weeks since
  nitrosoureas or mitomycin)

Endocrine therapy:
  No concurrent corticosteroids

Radiotherapy:
  At least 4 weeks since radiotherapy

Surgery:
  Not specified

Other:
  No prior bone marrow transplant
  No chronic requirement for anticoagulants, e.g., coumadin
  No concurrent NSAIDs

Patient Characteristics:

Age:
  18 and over

Performance status:
  ECOG 0 or 1

Life expectancy:
  At least 12 weeks

Hematopoietic:
  (within 2 weeks prior to entry)
  ANC at least 1,200
  Platelets at least 100,000

Hepatic:
  (within 2 weeks prior to entry)
  Bilirubin no more than 2.0 mg/dl
  SGOT and SGPT no more than 2 x normal
  Alkaline phosphatase no more than 2 x normal

Renal:
  (within 2 weeks prior to entry)
  Creatinine no more than 2.0 mg/dl 
  Creatinine clearance greater than 50 ml/min

Cardiovascular:
  LVEF normal on MUGA scan
  No past or present history of atherosclerotic cardiovascular
     disease
  No history of arrhythmia
  No history of CHF
  Treadmill test required of high-risk asymptomatic patients
     prior to entry

Pulmonary:
  No symptomatic obstructive or restrictive lung disease

Other:
  No severe symptomatic CNS disease of any type
  No active peptic ulcer disease
  No active infection
  No HIV seropositivity
  No second malignancy within 5 years except:
     In situ cervical cancer
     Nonmelanomatous skin cancer 
  No pregnant women
  Effective contraception required of fertile women

Expected Enrollment

35 patients will be entered over 2 years.  If no more than 1 response is noted 
in the first 20 patients, accrual will cease.

Outline

Nonrandomized study

Biological Response Modifier Therapy.  Interleukin-4 (Schering), IL-4, 
NSC-618085.

Trial Contact Information

Trial Lead Organizations

Ireland Cancer Center at University Hospitals/Case Medical Center

Brenda Cooper, MD, Protocol chair		Ph: 216-844-3213 Email: bxc12@po.cwru.edu