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| Sponsors and Collaborators: |
University of Pennsylvania National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00066404 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Cancer |
Biological: recombinant adenovirus-hIFN-beta |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | A Phase I Clinical Trial of Intrapleural Adenoviral-Mediated Interferon-Beta (IFN-ß) Gene Transfer for Pleural Malignancies |
| Study Start Date: | April 2003 |
OBJECTIVES:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
One of the following histologically or cytologically confirmed diagnoses:
Metastatic malignancy to the pleural space
Originating from 1 of the following sites:
No known brain metastases
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age
Sex
Menopausal status
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Contacts and Locations| United States, Pennsylvania | |
| Abramson Cancer Center of the University of Pennsylvania | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Study Chair: | Daniel H. Sterman, MD | University of Pennsylvania |
More Information
| Study ID Numbers: | CDR0000315899, UPCC-01502 |
| Study First Received: | August 6, 2003 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00066404 History of Changes |
| Health Authority: | United States: Federal Government |
|
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 |
|
Thoracic Neoplasms Rectal Neoplasms Pancreatic Neoplasms Vaginal Cancer Breast Cancer, Male Anal Cancer Lung Neoplasms Vaginal Neoplasms Testicular Cancer Interferon-beta Urinary Bladder Neoplasms Breast Neoplasms Esophageal Cancer Testicular Neoplasms Carcinoma |
Carcinoma, Small Cell Breast Neoplasms, Male Esophageal Disorder Gestational Trophoblastic Neoplasms Carcinoid Tumor Gallbladder Neoplasms Esophageal Diseases Stomach Cancer Anus Neoplasms Prostatic Neoplasms Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial Pleural Neoplasms Fallopian Tube Cancer Esophageal Neoplasms |
|
Thoracic Neoplasms Respiratory Tract Neoplasms Neoplasms by Histologic Type Neoplasms, Mesothelial Pleural Diseases Pleural Effusion, Malignant Pleural Effusion |
Neoplasms Neoplasms by Site Respiratory Tract Diseases Mesothelioma Adenoma Neoplasms, Glandular and Epithelial Pleural Neoplasms |