Patient case: 50-year-old female with Lung cancer. Genetic variant: EGFR (L858R). Other conditions: Lupus.

Clinical trial: Intrapleural BG00001 in Treating Patients With Malignant Pleural Mesothelioma or Malignant Pleural Effusions

Summary: RATIONALE: Using BG00001 to insert the gene for interferon-beta into a person's pleural cavity may improve the body's ability to fight cancer.
  PURPOSE: Phase I trial to study the effectiveness of intrapleural BG00001 in treating patients who have malignant pleural mesothelioma or malignant pleural effusions.

Detailed description: OBJECTIVES:
  -  Determine the safety and toxicity of intrapleural BG00001 in patients with malignant pleural mesothelioma or malignant pleural effusions.
  -  Determine the maximum tolerated dose of this drug in these patients.
  -  Determine the success of gene transfer/interferon beta gene expression in patients treated with this drug.
  -  Determine systemic and intrapleural cytokine responses and cellular and humoral immune response in patients treated with this drug.
  -  Determine, preliminarily, tumor response in patients treated with this drug.
  OUTLINE: This is a dose-escalation study.
  Patients receive BG00001 via an intrapleural catheter on day 1.
  Cohorts of 3-6 patients receive escalating doses of BG00001 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which no more than 1 of 6 patients experiences dose-limiting toxicity.
  Patients are followed weekly for 1 month, biweekly for 1 month, monthly for 4 months, and then every 6 months for 15 years.
  PROJECTED ACCRUAL: A total of 3-18 patients will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS:
  -  One of the following histologically or cytologically confirmed diagnoses:
  -  Malignant pleural mesothelioma
  -  Metastatic malignancy to the pleural space
  -  Originating from 1 of the following sites:
  -  Lung
  -  Breast
  -  Gastrointestinal organs
  -  Genitourinary organs
  -  Malignant melanoma
  -  Failed prior standard therapy comprising chemotherapy, radiotherapy, and/or hormonal therapy
  -  Measurable or evaluable disease
  -  Pleural space involved with tumor accessible for pleural catheter insertion
  -  No malignant pleural effusions secondary to lymphoma or sarcoma
  -  No rapidly re-accumulating, symptomatic pleural effusions after thoracentesis or pleural catheter insertion that require immediate mechanical or chemical pleurodesis
  -  No known brain metastases
  -  Previously treated brain metastases with no evidence of active growth are allowed
  -  Hormone receptor status:
  -  Not specified
  PATIENT CHARACTERISTICS:
  Age
  -  18 and over
  Sex
  -  Male or female
  Menopausal status
  -  Not specified
  Performance status
  -  ECOG 0-1
  Life expectancy
  -  Not specified
  Hematopoietic
  -  Granulocyte count at least 2,000/mm^3
  -  Platelet count at least 100,000/mm^3
  -  Hematocrit at least 30% (transfusion allowed)
  Hepatic
  -  Bilirubin no greater than 1.5 times upper limit of normal (ULN)
  -  ALT and AST no greater than 1.5 times ULN
  -  Alkaline phosphatase no greater than 1.5 times ULN
  -  PT and PTT no greater than 1.5 times normal
  -  No end-stage liver disease
  -  No chronic active hepatitis B (hepatitis B surface antigen negative)
  Renal
  -  Creatinine no greater than 2.0 mg/dL
  -  No end-stage renal disease
  Cardiovascular
  -  No unstable angina
  Pulmonary
  -  FEV_1 greater than 50% of predicted (post-pleural drainage)
  -  No severe oxygen-dependent chronic obstructive pulmonary disease
  Other
  -  Not pregnant or nursing
  -  Negative pregnancy test
  -  Fertile patients must use effective contraception
  -  HIV negative
  -  No documented immunodeficiency
  -  No other malignancy within the past 5 years except nonmelanoma skin cancer or successfully treated localized malignancy of the bladder or prostate gland with no evidence of active disease
  -  No other life-threatening illness
  -  No known hypersensitivity to any component of study treatment
  PRIOR CONCURRENT THERAPY:
  Biologic therapy
  -  More than 4 weeks since prior biologic therapy
  -  No prior bone marrow transplantation, including stem cells
  -  No immunological drugs during and for at least 2 months after study therapy
  Chemotherapy
  -  See Disease Characteristics
  -  No chemotherapy during and for at least 2 months after study therapy
  Endocrine therapy
  -  See Disease Characteristics
  -  Concurrent hormonal therapy allowed if maintained at dose received prior to study entry
  -  No concurrent steroids
  Radiotherapy
  -  See Disease Characteristics
  -  More than 4 weeks since prior radiotherapy
  -  No radiotherapy during and for at least 2 months after study therapy
  Surgery
  -  At least 2 weeks since prior surgery
  Other
  -  More than 4 weeks since prior cytotoxic agents
  -  No concurrent immunosuppressives or medication that can directly or indirectly suppress the immune system
  -  No other concurrent experimental therapies for pleural cancer

Relevance to patient case: not relevant