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

Alternate Title

Erb-38 Immunotoxin in Treating Patients With Advanced Solid Tumors

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase I Treatment Completed 18 and over NCI NCI-98-C-0020B NCI-T97-0087, T97-0087

Objectives

I.  Assess the toxicity of erb-38 in patients with cancer resistant to 
conventional therapy.

II.  Monitor any clinical response in this patient population.

III. Monitor the pharmacokinetics and immunogenicity of this therapy in these 
patients.

Entry Criteria

Disease Characteristics:

Histologically or cytologically proven advanced solid tumors that are
refractory to standard treatment or for which no effective standard therapy
exists, e.g.:
    Breast cancer                           Bladder cancer
    Non-small cell lung cancer              Gastric cancer
    Ovarian cancer                          Colon cancer

Measurable or evaluable

erbB-2 antigen must be present on the surface of greater than 30% of tumor
cells

No CNS metastases

Hormone receptor status:
 Not specified

Prior/Concurrent Therapy:

Biologic therapy:
 Not specified

Chemotherapy:
 No chemotherapy within past 3 weeks (6 weeks for mitomycin or nitrosoureas)
  and recovered

Endocrine therapy:
 No hormonal therapy within past 3 weeks

Radiotherapy:
 No radiotherapy within past 3 weeks and recovered

Surgery:
 Not specified

Patient Characteristics:

Age:
 18 and over

Menopausal status:
 Not specified

Performance status:
 ECOG 0 or 1

Life expectancy:
 At least 3 months

Hematopoietic:
 Absolute granulocyte count greater than 1200/mm3
 Platelet count greater than 75,000/mm3

Hepatic:
 SGOT and SGPT no greater than 1.5 times upper limit of normal
 Bilirubin within normal limits
 No history of any prior liver disease (metastatic liver disease from primary
  tumor allowed if SGOT and SGPT requirements are met)

Renal:
 Creatinine no greater than 1.4 mg/dL

Other:
 Not pregnant or nursing
 Fertile patients must use effective contraception
 No other concurrent malignancy
 No known seizure disorders
 Not hepatitis B antigen positive
 No presence of neutralizing antibodies to erb-38

Expected Enrollment

Approximately 30 patients will be accrued for this study within 18-24 months.

Outline

This is a dose escalation study.

Patients receive a test dose of erb-38 30 minutes before the first dose of 
each course on day 1.  Patients then receive a single course of treatment with 
erb-38 administered intravenously over 30 minutes on days 1, 3, and 5.  
Patients with stable or responding disease who have not produced neutralizing 
antibodies to erb-38 may receive additional courses of therapy every 28 days 
without an increase in dosage.

Dose escalation continues until the maximum tolerated dose (MTD) is 
determined.  The MTD is defined as the dose preceding that at which 2 or more 
patients experience dose limiting toxicity.

Patients are followed at 4 weeks after each course of therapy and every 2 
months thereafter.

Trial Contact Information

Trial Lead Organizations

NCI - Center for Cancer Research

Lee Pai-Scherf, MD, Protocol chair(Contact information may not be current)		Ph: 301-496-9458 Email: lpai@helix.nih.gov