NCT00066404

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Apr 2003

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2003

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 6, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 7, 2003

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2006

Completed
Last Updated

May 13, 2020

Status Verified

May 1, 2020

Enrollment Period

2.8 years

First QC Date

August 6, 2003

Last Update Submit

May 12, 2020

Conditions

Cancer

Keywords

advanced malignant mesotheliomamale breast cancerlocalized malignant mesotheliomarecurrent bladder cancerrecurrent renal cell cancerrecurrent urethral cancerrecurrent breast cancerrecurrent penile cancerrecurrent prostate cancerrecurrent anal cancerrecurrent colon cancerrecurrent esophageal cancerrecurrent gastric cancerrecurrent pancreatic cancerrecurrent rectal cancerrecurrent gastrointestinal carcinoid tumorrecurrent small intestine cancerrecurrent gallbladder cancerrecurrent extrahepatic bile duct cancerrecurrent adult primary liver cancerrecurrent non-small cell lung cancerrecurrent small cell lung cancerrecurrent thymoma and thymic carcinomarecurrent melanomarecurrent malignant mesotheliomarecurrent malignant testicular germ cell tumorrecurrent cervical cancerrecurrent ovarian epithelial cancerfallopian tube cancerrecurrent vulvar cancerrecurrent vaginal cancerrecurrent gestational trophoblastic tumorrecurrent endometrial carcinomarecurrent ovarian germ cell tumormalignant pleural effusion

Interventions

recombinant adenovirus-hIFN-betaBIOLOGICAL

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

  • 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.

    PMID: 20068553RESULT

MeSH Terms

Conditions

NeoplasmsBreast Neoplasms, MaleUrinary Bladder NeoplasmsCarcinoma, Renal CellUrethral NeoplasmsBreast NeoplasmsPenile NeoplasmsProstatic NeoplasmsAnus NeoplasmsColonic NeoplasmsEsophageal NeoplasmsStomach NeoplasmsPancreatic NeoplasmsRectal NeoplasmsGallbladder NeoplasmsBile Duct NeoplasmsCarcinoma, HepatocellularCarcinoma, Non-Small-Cell LungSmall Cell Lung CarcinomaThymomaMelanomaMesothelioma, MalignantTesticular NeoplasmsUterine Cervical NeoplasmsCarcinoma, Ovarian EpithelialFallopian Tube NeoplasmsVulvar NeoplasmsVaginal NeoplasmsGestational Trophoblastic DiseaseEndometrial NeoplasmsPleural Effusion, Malignant

Condition Hierarchy (Ancestors)

Neoplasms by SiteBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesUrologic NeoplasmsUrogenital NeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeKidney NeoplasmsKidney DiseasesUrethral DiseasesGenital Neoplasms, MaleGenital Diseases, MaleGenital DiseasesPenile DiseasesProstatic DiseasesColorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesAnus DiseasesRectal DiseasesColonic DiseasesHead and Neck NeoplasmsEsophageal DiseasesStomach DiseasesEndocrine Gland NeoplasmsPancreatic DiseasesEndocrine System DiseasesBiliary Tract NeoplasmsBiliary Tract DiseasesGallbladder DiseasesBile Duct DiseasesLiver NeoplasmsLiver DiseasesCarcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract DiseasesNeoplasms, Complex and MixedThymus NeoplasmsLymphatic DiseasesHemic and Lymphatic DiseasesNeuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsMesotheliomaAdenomaNeoplasms, MesothelialPleural NeoplasmsTesticular DiseasesGonadal DisordersUterine NeoplasmsGenital Neoplasms, FemaleUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleOvarian NeoplasmsOvarian DiseasesAdnexal DiseasesFallopian Tube DiseasesVulvar DiseasesVaginal DiseasesTrophoblastic NeoplasmsPregnancy Complications, NeoplasticPregnancy ComplicationsPleural EffusionPleural Diseases

Study Officials

  • Daniel H. Sterman, MD

    Abramson Cancer Center at Penn Medicine

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 6, 2003

First Posted

August 7, 2003

Study Start

April 1, 2003

Primary Completion

January 1, 2006

Study Completion

January 1, 2006

Last Updated

May 13, 2020

Record last verified: 2020-05

Locations

US(1)