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.
Checked against the public recordLast updated May 13, 2020 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1
- Sponsor
- Abramson Cancer Center at Penn Medicine
- Interventions being studied
- Biological: recombinant adenovirus-hIFN-beta
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Abramson Cancer Center of the University of PennsylvaniaPhiladelphia, Pennsylvania
Source and freshness
Processed from ClinicalTrials.gov. Last public update: May 13, 2020. Always confirm current availability with the study team.