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

Primary Purpose

Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
recombinant adenovirus-hIFN-beta
Sponsored by
Abramson Cancer Center at Penn Medicine
About
Eligibility
Locations
Outcomes
Full info

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

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
August 6, 2003
Last Updated
May 12, 2020
Sponsor
Abramson Cancer Center at Penn Medicine
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00066404
Brief Title
Intrapleural BG00001 in Treating Patients With Malignant Pleural Mesothelioma or Malignant Pleural Effusions
Official Title
A Phase I Clinical Trial of Intrapleural Adenoviral-Mediated Interferon-beta (IFN-ß) Gene Transfer for Pleural Malignancies
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
April 2003 (undefined)
Primary Completion Date
January 2006 (Actual)
Study Completion Date
January 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abramson Cancer Center at Penn Medicine
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
recombinant adenovirus-hIFN-beta

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel H. Sterman, MD
Organizational Affiliation
Abramson Cancer Center at Penn Medicine
Official's Role
Study Chair
Facility Information:
Facility Name
Abramson Cancer Center of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20068553
Citation
Sterman DH, Recio A, Haas AR, Vachani A, Katz SI, Gillespie CT, Cheng G, Sun J, Moon E, Pereira L, Wang X, Heitjan DF, Litzky L, June CH, Vonderheide RH, Carroll RG, Albelda SM. A phase I trial of repeated intrapleural adenoviral-mediated interferon-beta gene transfer for mesothelioma and metastatic pleural effusions. Mol Ther. 2010 Apr;18(4):852-60. doi: 10.1038/mt.2009.309. Epub 2010 Jan 12.
Results Reference
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Intrapleural BG00001 in Treating Patients With Malignant Pleural Mesothelioma or Malignant Pleural Effusions

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