Further study details as provided by National Cancer Institute (NCI):

Study Start Date: Â

April 2003

Detailed Description:

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

advanced malignant mesothelioma   localized malignant mesothelioma   recurrent malignant mesothelioma   male breast cancer   recurrent bladder cancer   recurrent renal cell cancer   recurrent urethral cancer   recurrent breast cancer   recurrent penile cancer   recurrent prostate cancer Â

recurrent anal cancer recurrent colon cancer recurrent esophageal cancer recurrent gastric cancer recurrent pancreatic cancer recurrent rectal cancer recurrent gastrointestinal carcinoid tumor recurrent small intestine cancer recurrent gallbladder cancer recurrent extrahepatic bile duct cancer

Thoracic Neoplasms Gestational trophoblastic disease Esophageal Neoplasms Pleural Effusion, Malignant Kidney cancer Ovarian epithelial cancer Melanoma Trophoblastic Neoplasms Endometrial cancer Rectal cancer

Esophageal neoplasm Bladder neoplasm Hepatocellular carcinoma Bile duct cancer, extrahepatic Non-small cell lung cancer Esophageal disorder Pleural Diseases Interferons Interferon-beta Vaginal cancer

Respiratory Tract Neoplasms Neoplasms Neoplasms by Site Neoplasms by Histologic Type

Mesothelioma Respiratory Tract Diseases Neoplasms, Mesothelial