Intrapleural BG00001 in Treating Patients With Malignant Pleural Mesothelioma or Malignant Pleural Effusions
This trial is active, not recruiting.
|Sponsor||Abramson Cancer Center of the University of Pennsylvania|
|Collaborator||National Cancer Institute (NCI)|
|Start date||April 2003|
|Trial identifier||NCT00066404, CDR0000315899, UPCC-01502|
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.
Male or female participants at least 18 years old.
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
|Official title||A Phase I Clinical Trial of Intrapleural Adenoviral-Mediated Interferon-beta (IFN-ß) Gene Transfer for Pleural Malignancies|
|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.|
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