Intrapleural BG00001 in Treating Patients With Malignant Pleural Mesothelioma or Malignant Pleural Effusions
Cancer
About this trial
This is an interventional treatment trial for Cancer focused on measuring advanced malignant mesothelioma, male breast cancer, localized malignant mesothelioma, recurrent bladder cancer, recurrent renal cell cancer, recurrent urethral cancer, recurrent breast cancer, recurrent penile cancer, recurrent prostate cancer, 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, recurrent adult primary liver cancer, recurrent non-small cell lung cancer, recurrent small cell lung cancer, recurrent thymoma and thymic carcinoma, recurrent melanoma, recurrent malignant mesothelioma, recurrent malignant testicular germ cell tumor, recurrent cervical cancer, recurrent ovarian epithelial cancer, fallopian tube cancer, recurrent vulvar cancer, recurrent vaginal cancer, recurrent gestational trophoblastic tumor, recurrent endometrial carcinoma, recurrent ovarian germ cell tumor, malignant pleural effusion
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
Sites / Locations
- Abramson Cancer Center of the University of Pennsylvania