Patient case: 49-year-old female with lung cancer; genetic feature: ERBB2

Clinical trial: Immunotoxin Therapy in Treating Patients With Advanced Cancer

Summary: RATIONALE: Immunotoxins can locate tumor cells and kill them without harming normal cells. Immunotoxin therapy may be an effective treatment for advanced cancer.
  PURPOSE: Phase I trial to study the effectiveness of immunotoxins in treating patients who have advanced cancer.

Detailed description: OBJECTIVES:
  Primary
  -  Determine the maximum tolerated dose and toxic effects of SS1(dsFv)-PE38 immunotoxin in patients with advanced malignancies that express mesothelin.
  Secondary
  -  Determine the response in patients treated with this drug.
  -  Determine the plasma pharmacokinetics of this drug in these patients.
  OUTLINE: This is an open-label, dose-escalation study.
  Patients receive SS1(dsFv)-PE38 immunotoxin IV continuously on days 1-10. Treatment repeats every 4 weeks for a maximum of 4 courses in the absence of disease progression or unacceptable toxicity.
  Cohorts of 3-6 patients receive escalating doses of SS1(dsFv)-PE38 immunotoxin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.
  Patients are followed every 3 months.
  PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS:
  -  Histologically confirmed malignancy, including one of the following:
  -  Malignant mesothelioma
  -  Ovarian epithelial carcinoma (mucinous or nonmucinous), including primary peritoneal or fallopian tube carcinoma
  -  Tumors that may have originated in the bowel (e.g., appendiceal carcinoma) and involve the ovary
  -  Ovarian cancers of other histology are eligible provided they express mesothelin
  -  Pancreatic cancer
  -  Squamous cell lung cancer
  -  Squamous cell cancer of the head and neck
  -  Squamous cell cancer of the cervix
  -  Recurrent unresectable disease after prior standard anticancer therapy that was expected to prolong survival and improve quality of life OR unwilling to receive standard anticancer therapy
  -  At least 30% of initial or recurrent tumor cells positive (at least 1+) for mesothelin by immunohistochemistry
  -  Measurable or evaluable disease
  -  No known CNS or spinal cord involvement
  -  No clinically significant pericardial effusion
  PATIENT CHARACTERISTICS:
  Age:
  -  18 and over
  Performance status:
  -  ECOG 0-2
  Life expectancy:
  -  At least 12 weeks
  Hematopoietic:
  -  Absolute neutrophil count at least 1,000/mm^3
  -  Platelet count at least 75,000/mm^3
  Hepatic:
  -  Bilirubin no greater than upper limit of normal (ULN)
  -  AST and ALT no greater than 2.5 times ULN
  -  Albumin at least 3.0 g/dL
  -  Hepatitis B and C negative
  Renal:
  -  Creatinine no greater than ULN OR
  -  Creatinine no greater than 2.0 mg/dL if creatinine clearance at least 50 mL/min
  -  Calcium no greater than ULN
  Cardiovascular:
  -  No New York Heart Association class II-IV heart disease
  Pulmonary:
  -  Oxygen saturation (SO_2) more than 92% on room air
  Other:
  -  Not pregnant or nursing
  -  Negative pregnancy test
  -  Fertile patients must use effective contraception
  -  HIV negative
  -  No detectable antibody to SS1(dsFv)-PE38
  -  No infection requiring parenteral antibiotics
  PRIOR CONCURRENT THERAPY:
  Biologic therapy:
  -  At least 1 week since prior hematopoietic growth factor therapy
  Chemotherapy:
  -  Not specified
  Endocrine therapy:
  -  Not specified
  Radiotherapy:
  -  Not specified
  Surgery:
  -  Not specified
  Other:
  -  At least 4 weeks since any prior antitumor therapy and recovered
  -  No other concurrent antitumor therapy

Relevance to patient case: not relevant