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

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Phase I Clinical Trial of Intrapleural Adenoviral-Mediated Interferon-beta (IFN-ß) Gene Transfer for Pleural Malignancies

Conditions
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Cancer

Intervention / Treatment
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* Biological: recombinant adenovirus-hIFN-beta


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: recombinant adenovirus-hIFN-beta|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recurrent colon cancer, 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 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