Intrapleural BG00001 in Treating Patien… | Clinical Trial

Key information

Conditions

Cancer Adenocarcinoma Adenoma Adnexal Diseases Anus Diseases Anus Neoplasms Bile Duct Diseases Bile Duct Neoplasms Biliary Tract Diseases Biliary Tract Neoplasms Breast Diseases Breast Neoplasms Breast Neoplasms, Male Bronchial Neoplasms Carcinoma Carcinoma, Bronchogenic Carcinoma, Hepatocellular Carcinoma, Non-Small-Cell Lung Carcinoma, Ovarian Epithelial Carcinoma, Renal Cell Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Endometrial Neoplasms Esophageal Diseases Esophageal Neoplasms Fallopian Tube Diseases Fallopian Tube Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gallbladder Diseases Gallbladder Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Female Genital Diseases, Male Genital Neoplasms, Female Genital Neoplasms, Male Gestational Trophoblastic Disease Gonadal Disorders Head and Neck Neoplasms Hemic and Lymphatic Diseases Intestinal Diseases Intestinal Neoplasms Kidney Diseases Kidney Neoplasms Liver Diseases Liver Neoplasms Lung Diseases Lung Neoplasms Lymphatic Diseases Male Urogenital Diseases Melanoma Mesothelioma Mesothelioma, Malignant Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Complex and Mixed Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Mesothelial Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Ovarian Diseases Ovarian Neoplasms Pancreatic Diseases Pancreatic Neoplasms Penile Diseases Penile Neoplasms Pleural Diseases Pleural Effusion Pleural Effusion, Malignant Pleural Neoplasms Pregnancy Complications Pregnancy Complications, Neoplastic Prostatic Diseases Prostatic Neoplasms Rectal Diseases Rectal Neoplasms Respiratory Tract Diseases Respiratory Tract Neoplasms Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases Small Cell Lung Carcinoma Stomach Diseases Stomach Neoplasms Testicular Diseases Testicular Neoplasms Thoracic Neoplasms Thymoma Thymus Neoplasms Trophoblastic Neoplasms Urethral Diseases Urethral Neoplasms Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms Vaginal Diseases Vaginal Neoplasms Vulvar Diseases Vulvar Neoplasms

Age range

18 year–120 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

recombinant adenovirus-hIFN-beta

Biological

Sponsors and collaborators

Lead sponsor

Abramson Cancer Center at Penn Medicine

Other

Collaborators

National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start: 2003
Primary completion: 2006
Study completion: 2006
First posted: Aug 7, 2003
Registry last updated: May 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed