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

Alternate Title

Rituximab and LMB-1 Immunotoxin in Treating Patients With Advanced Stage Solid Tumors

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Completed	18 and over	NCI	NCI-99-C-0071 MB-409, NCI-T98-0086, T98-0086

Objectives

I.  Assess the ability of rituximab to inhibit human antibody response to 
LMB-1 immunotoxin in patients with advanced solid tumors that express the B3 
antigen.

II.  Monitor the side effects of LMB-1 immunotoxin and rituximab when given in 
combination to these patients.

III.  Monitor the kinetics of these drugs following intravenous injection in 
this patient population.

IV.  Assess any clinical responses to this treatment in these patients.

Entry Criteria

Disease Characteristics:

Histologically or cytologically confirmed advanced stage solid tumor that is
refractory to standard treatment or for which no effective standard therapy
exists, including the following cancers:
 Colon
 Breast
 Non-small cell lung
 Gastric
 Esophageal

 Bladder
 Pancreatic
 Lymphoma excluded

Measurable or evaluable disease

Presence of B3 antigen on surface of greater than 30% of tumor cells

No history of CNS metastasis

Prior/Concurrent Therapy:

Biologic therapy:
 Not specified

Chemotherapy:
 At least 3 weeks since prior chemotherapy (6 weeks for mitomycin or
  nitrosoureas) and recovered

Endocrine therapy:
 At least 3 weeks since prior hormonal therapy

Radiotherapy:
 At least 3 weeks since prior radiotherapy and recovered

Surgery:
 Not specified

Patient Characteristics:

Age:
 18 and over

Performance status:
 ECOG 0-1

Life expectancy:
 At least 3 months

Hematopoietic:
 Granulocyte count at least 1,500/mm3
 Platelet count greater than 100,000/mm3

Hepatic:
 SGOT/SGPT no greater than 2.5 times upper limit of normal
 Bilirubin less than 1.5 mg/dL
 No hepatitis B
 No hepatitis C
 Albumin at least 3.0 g/dL

Renal:
 Creatinine no greater than 1.4 mg/dL

Cardiovascular:
 No history of coronary artery disease
 No New York Heart Association class II-IV heart disease
 No arrhythmia requiring treatment
 No contraindication to pressor therapy

Pulmonary:
 FEV1 and FVC greater than 65% of predicted in patients with history of
  smoking or suspicion of pulmonary disease

Neurologic:
 No known seizure disorder

Other:
 HIV negative
 No other concurrent malignancy
 No acute bacterial infection that requires antibiotic therapy
 No coexisting medical or psychiatric condition that is likely to interfere
  with study procedures and/or results
 No history of allergic reaction to penicillin
 Not pregnant or nursing
 Negative pregnancy test
 Fertile patients must use effective contraception

Expected Enrollment

A total of 10-20 patients will be accrued for this study within 12-24 months.

Outline

Patients receive rituximab IV on days 1 and 7.  LMB-1 immunotoxin IV is 
administered over 30 minutes on days 10, 12, and 14.  Patients with stable or 
responding disease receive additional courses of LMB-1 immunotoxin on days 1, 
3, and 5 every 28 days provided that there are no neutralizing antibodies 
against LMB-1 immunotoxin or unacceptable toxicity.

Patients are followed at 1 month after treatment and then every 2 months 
thereafter.

Trial Contact Information

Trial Lead Organizations

NCI - Center for Cancer Research

Ira Pastan, MD, Protocol chair		Ph: 301-496-4797