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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase I Treatment Closed over 18 UCHSC-91264 NCI-V91-0216

Objectives

I.  Assess tumor localization by radioimaging with iodine-131-labeled murine 
monoclonal antibody LL2 (131I-LL2), and estimate radiation dose to tumor and 
normal tissue.

II.  Describe serum levels of monoclonal antibody and radiolabel disappearance 
following administration of 131I-LL2 in patients with B-cell non-Hodgkin's 
lymphoma reactive with monoclonal antibody LL2.

III.  Assess target antigen expression and saturation in malignant tissue 
following therapy via biopsy of accessible lesions.

IV.  Assess any antitumor response to a 131I-LL2 in these patients.

V.  Estimate the maximum tolerated dose and evaluate the clinical toxicity of 
131I-LL2 in these patients.

Entry Criteria

Disease Characteristics:

Histologically confirmed B-cell non-Hodgkin's lymphoma that is reactive with
monoclonal antibody LL2

Stage III/IV disease that has failed at least 1 prior standard chemotherapy
regimen required

Measurable or evaluable disease required

No CNS involvement

Prior/Concurrent Therapy:

No prior murine monoclonal antibody therapy

At least 3 weeks since cytotoxic chemotherapy, radiotherapy, and/or
immunosuppressant agents

Patient Characteristics:

Age:
  Over 18

Performance status:
  Karnofsky 70-100% and fully ambulatory

Life expectancy:
  Greater than 2 months

Hematopoietic:
  WBC greater than 3,000
  AGC at least 1,500
  Platelets greater than 100,000
  Hb greater than 10 g/dl (untransfused)

Hepatic:
  Bilirubin less than 3.0 mg/dl

Renal:
  Creatinine less than 2.0 mg/dl
  No glomerulonephritis

Cardiovascular:
  No NYHA class 3/4 status

Other:
  No vasculitis or other active collagen vascular disease
  No rheumatoid arthritis
  No other serious illness
  No other active malignancy
  No pregnant women
  Effective contraception required of fertile patients

Blood/body fluid analyses to determine eligibility and imaging studies and
physical exams for tumor measurement completed within 14 days prior to
registration

Expected Enrollment

12 patients will be studied over 12-16 months.

Outline

Radioimmunotherapy.  Iodine-131-Labeled Murine Monoclonal Antibody LL2, 
131I-LL2.

Trial Contact Information

Trial Lead Organizations

University of Colorado Cancer Center at UC Health Sciences Center

Paul Bunn, MD, Protocol chair		Ph: 303-724-3155; 800-473-2288 Email: paul.bunn@uchsc.edu