CancerPhase 1NCT00066404
Intrapleural BG00001 in Treating Patients With Malignant Pleural Mesothelioma or Malignant Pleural Effusions
A Phase 1 study testing recombinant adenovirus-hIFN-beta in people with Cancer, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Cancer
- What is being tested?
- recombinant adenovirus-hIFN-beta
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Apr 2003to Jan 2006
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
United States1 site
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: A Phase I Clinical Trial of Intrapleural Adenoviral-Mediated Interferon-beta (IFN-ß) Gene Transfer for Pleural Malignancies
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.
Read the 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.
- Conditions
- Cancer
- Being tested
- recombinant adenovirus-hIFN-beta
- 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
- Medical subject headings
- Neoplasms, Breast Neoplasms, Male, Urinary Bladder Neoplasms, Carcinoma, Renal Cell, Urethral Neoplasms, Breast Neoplasms, Penile Neoplasms, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
recombinant adenovirus-hIFN-betaBiological
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2003 (estimated)
- Study startApr 2003
- Primary completionJan 2006
- Study completionJan 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Abramson Cancer Center at Penn MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
Sponsor and investigators
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Daniel H. Sterman, MD, Study chair, Abramson Cancer Center at Penn Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00066404
- Sponsor's protocol ID
- CDR0000315899
- Other IDs
- UPCC-01502
- Status last verified
- May 2020
- First submitted
- 6 Aug 2003
- Last updated
- 13 May 2020
- Results posted
- No
Publications
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.
PubMed 20068553
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Trial of Intrapleural Adenoviral-Mediated Interferon-beta (IFN-ß) Gene Transfer for Pleural Malignancies
- ClinicalTrials.gov ID
- NCT00066404
- Acronym / sponsor ID
- CDR0000315899
- Conditions
- 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
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Abramson Cancer Center at Penn MedicineUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Apr 2003
- Primary completion
- Jan 2006 (actual)
- Study completion
- Jan 2006 (actual)
- First posted
- 7 Aug 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| recombinant adenovirus-hIFN-beta | Biological | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2020.
- Results publication: PubMed 20068553Sterman 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel H. Sterman, MD study chair
Abramson Cancer Center at Penn Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing recombinant adenovirus-hIFN-beta in people with Cancer, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00066404, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2020.