Intrapleural BG00001 in Treating Patients With Malignant Pleural Mesothelioma or Malignant Pleural Effusions

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.

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 Criteria:
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