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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II, Phase I Treatment Closed over 17 to physiologic 70 LAC-USC-13NHL883 NCI-B88-0010, B88-0010

Objectives

I.  Determine the antitumor efficacy of interleukin-2 (IL-2) plus the murine 
IgG2a monoclonal antibody Lym-1 (Lym-1 MoAb) in patients with B-cell lymphomas.
II.  Compare the immune modulatory effects of IL-2/Lym-1 MoAb to those of 
Lym-1 MoAb alone.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Patients greater than 17 years to 
physiologic 70 years of age with any low- or intermediate-grade B-cell 
lymphoma that is refractory to standard therapy, either primary or relapsed 
with less than 3 prior therapies.  Evidence of bone marrow involvement with 
tumor on marrow biopsy excludes.  Lym-1 MoAb binding against a sample biopsy 
of the patient's tumor must be demonstrated in vitro by immunoperoxidase 
technique on frozen tissue; patients must have no allergic response to an 
intradermal challenge of Lym-1 MoAb (1 mg) prior to treatment.  At least 2 
weeks must have elapsed since any chemotherapy, radiotherapy, or steroid 
therapy; prior therapy with any monoclonal antibody or IL-2 is not allowed.  
Measurable disease must be present.  A Karnofsky performance status of greater 
than 80% is required, as are the following renal, hepatic, and hematologic 
parameters:  creatinine less than 1.5 mg/dl or creatinine clearance at least 
60 ml/minute; liver tests (enzymes and bilirubin) no greater than twice 
normal; and WBC at least 4,000 and platelets at least 100,000 (unless there is 
bone marrow involvement with lymphoma/leukemia).  Patients must have adequate 
pulmonary function; those with risk factors for pulmonary disease (i.e., prior 
bleomycin therapy, x-ray therapy to lung, or smoking) should be given 
pulmonary function tests and should have an FEV1 of 2 liters or 75% of 
predicted.  The following conditions exclude:  a functional New York Heart 
Association classification of II or worse; active CNS disease that has not 
been adequately treated; a second active neoplasm other than basal or squamous 
cell carcinoma of the skin or carcinoma in situ of the cervix; or any medical, 
social, or psychological factors that would prevent the patient from receiving 
or cooperating with the full course of therapy.  A past history or family 
history of malignant hyperthermia associated with anesthesia should be 
discussed with the Investigational Drug Branch prior to entry; patients with 
fever secondary to malignant disease should be closely monitored following 
IL-2 administration.  Pregnancy excludes.

Expected Enrollment

10 patients will be accrued on each arm over one year.

Outline

Nonrandomized study.
Biological Response Modifier Therapy.  Lym-1 MoAb; Interleukin-2 (Cetus), 
IL-2, NSC-373364.

Trial Contact Information

Trial Lead Organizations

USC/Norris Comprehensive Cancer Center and Hospital

Amitabha Mazumder, MD, Protocol chair		Ph: 305-243-4929