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 to physiologic 64 NCI NU-T93-0040 NCI-T93-0040O, T93-0040

Objectives

I.  Examine the response rate, time to response, duration of response, and 
survival of patients with relapsed/refractory hairy cell leukemia treated with 
the monoclonal antibody anti-B4 conjugated with blocked ricin (anti-B4-bR).

II.  Investigate the toxicities of anti-B4-bR in these patients.

Entry Criteria

Disease Characteristics:

Histologically proven hairy cell leukemia (HCL) that is
refractory or relapsed following 2-chlorodeoxyadenosine (2-CdA)
and interferon (IFN) therapy
  Histology documented by bone marrow core biopsy

Tumor cell reactivity to monoclonal antibodies anti-B4 (CD19),
anti-B1 (CD20), or L26 (CD20) demonstrated by flow cytometry or
immunoperoxidase staining

Active HCL demonstrated by at least one of the following:
  Clinically significant progressive cytopenias:
     Hemoglobin less than 12 g/dl
     ANC less than 1,500
     Platelets less than 100,000
  Symptomatic splenomegaly attributed to HCL
  Symptomatic adenopathy attributed to HCL
  Recurrent infections requiring systemic antibiotics

Prior/Concurrent Therapy:

Biologic therapy:
  At least 4 weeks since biologic therapy including IFN
  No prior murine monoclonal antibodies
  No prior ricin derivatives

Chemotherapy:
  At least 4 weeks since chemotherapy including nucleoside
  analogs (e.g., 2-CdA, fludarabine, 2-deoxycoformycin)

Endocrine therapy:
  Not specified

Radiotherapy:
  Not specified

Surgery:
  Not specified

Patient Characteristics:

Age:
  18 to physiologic 64

Performance status:
  ECOG 0-2

Hematopoietic:
  Platelets at least 50,000

Hepatic:
  Bilirubin less than 1.2 x ULN
  SGOT and SGPT less than 3 x ULN
  Albumin greater than 0.8 x LLN

Renal:
  Creatinine no greater than 2.0 mg/dl OR
  Creatinine clearance at least 60 ml/min

Cardiovascular:
  No NYHA class III/IV status, i.e.:
     No uncontrolled CHF
     No uncontrolled angina pectoris
     No uncontrolled arrhythmia

Other:
  HIV seronegative
  No hypersensitivity to rodent proteins or ricin derivatives
  No active second malignancy except:
     Curatively treated cervical carcinoma in situ
     Curatively treated basal cell skin cancer
  No active acute or chronic infection
  No other significant medical or psychiatric illness that
     would preclude informed consent
  No pregnant women
  Adequate contraception required
  Accessibility for treatment and follow-up required

Blood/body fluid analyses, imaging studies, and bone marrow
exam to determine eligibility completed within 14 days prior to
registration.

Expected Enrollment

If there are at least 2 responses among the first 16 evaluable patients, an 
additional 9 evaluable patients will be entered.

Outline

Monoclonal Antibody Conjugate Therapy.  Monoclonal antibody Anti-B4 conjugated 
with blocked ricin, Anti-B4-bR, NSC-639185.

Trial Contact Information

Trial Lead Organizations

Robert H. Lurie Comprehensive Cancer Center at Northwestern University

Martin Tallman, MD, Protocol chair		Ph: 312-695-0990