Glioblastoma MultiformePhase 1NCT00031083
Dose Escalation Study to Determine the Safety of IFN-Beta Gene Transfer in the Treatment of Grade III & Grade IV Gliomas
A Phase 1 study testing Interferon-beta in people with Glioblastoma Multiforme and Anaplastic Astrocytoma, run by Biogen at 5 sites in United States.
Trial summary
In this study an investigational replication-defective, recombinant adenovirus expressing the interferon-beta gene (BG00001) will be directly injected into tumors, in patients with recurrent Grade III and Grade IV Gliomas, in order to deliver the hIFN-beta gene. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma Multiforme, Anaplastic Astrocytoma, Oligoastrocytoma, Mixed
- What is being tested?
- Interferon-beta
- How many people
- 12 participants
- Where
- 5 sitesUnited States
- Study dates
- 2 Apr 2002to 10 Oct 2003
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must be greater than or equal to 18 years of age.
- Subjects must have histologically proven GBM, AA, AMO, malignant astrocytoma NOS or gliosarcoma and recurrent or progressive tumor following prior treatment.
- Tumor must be amenable to radical resection, and resection must be clinically indicated.
- Must have an ECOG performance status of 0-2.
- Must be on anticonvulsant therapy, and must have therapeutic serum levels within 2 weeks prior to Day 1, if therapeutic levels are defined for the anticonvulsant being used.
Who cannot join
- Abnormal blood tests exceeding any of the limits defined below:
- Alanine transaminase (ALT) > four times (4X) the upper limit of normal (ULN).
- Aspartate transaminase (AST) > 4X the ULN.
- Total bilirubin >1.5 mg/dL.
- Absolute neutrophil count <1,500 cells/mm3.
- Platelet count <100,000 cells/mm3.
Show all 23Show fewer
- Serum creatinine >2X ULN.
- Prothrombin time (PT) >2 seconds above the ULN.
- Serum sodium (Na) <125 mEq/L or >150 mEq/L.
- Serum potassium (K) <3.5 mEq/L or > 5.5 mEq/L.
- Brainstem, or optic chiasm involvement of tumor.
- Uncontrolled seizure disorder.
- History of a new diagnosis or treatment of an invasive malignancy other than Grade III or Grade IV Glioma within 5 years of enrollment. Curatively treated subjects with a history of basal cell or squamous cell carcinoma of the skin, superficial transitional cell carcinoma of the bladder, and non-invasive carcinoma of the uterine cervix are not excluded.
- Treatment History:
- Treatment with radiation therapy, including interstitial radiation or radiosurgery, must be completed at least 8 weeks prior to Day 1.
- Treatment with nitrosoureas must be completed at least 6 weeks prior to Day 1. Treatment with other chemotherapeutic agents must be completed at least 4 weeks prior to Day 1.
- Treatment with any investigational drug or approved therapy for investigational use must be completed at least 4 weeks prior to Day 1.
- History of intolerance to corticosteroids that would preclude use during this study, or history of any medical condition that precludes the use of corticosteroids.
- Any prior treatment with a gene delivery vector, or an adenovirus therapeutic.
- Women of child bearing potential must have a negative serum pregnancy test.
- Women who are not postmenopausal, surgically sterile, or willing to practice effective contraception during the study. Men who are not surgically sterile or willing to practice effective contraception during the study.
- Nursing mothers, pregnant women and women planning to become pregnant while on study.
- Previous treatment with BG00001.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Massachusetts General Hospital
Boston, Massachusetts, 2114
University of Colorado Health Sciences Center
Denver, Colorado, 80262
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
University of Arizona at Tucson
Tucson, Arizona, 85724
About this study
Official title: A Multi-center, Open Label, Two Part, Dose Escalation Study to Determine the Tolerability of Interferon-Beta Gene Transfer (BG00001) in the Treatment of Recurrent or Progressive Grade III and Grade IV Gliomas
In this study an investigational replication-defective, recombinant adenovirus expressing the interferon-beta gene (BG00001) will be directly injected into tumors, in patients with recurrent Grade III and Grade IV Gliomas, in order to deliver the hIFN-beta gene. The purpose of the study is to evaluate the safety and any harmful effects of injection of BG00001 into brain tumors. Also, this study will help determine whether the virus carrying the beta interferon gene will enter brain tumor cells and cause the cancer cells to die. This study will require one hospital admission for the actual procedure of drug administration. All other visits will be conducted on an out-patient basis
- Being tested
- Interferon-beta
- Keywords
- Glioma, Brain Tumor, Adenovirus, Gene Therapy, Biogen
- Medical subject headings
- Glioblastoma, Astrocytoma, Gliosarcoma, Glioma, Brain Neoplasms, Adenoviridae Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interferon-betaGenetic
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2002 (estimated)
- Study start2 Apr 2002
- Study completion10 Oct 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glioblastoma MultiformeStudies of the same condition, open and under way.
- More trials run by BiogenThe 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
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants
Sponsor and investigators
- Lead sponsor
- Biogen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Biogen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00031083
- Sponsor's protocol ID
- C-1502
- Other IDs
- 0101-453
- Status last verified
- Nov 2020
- First submitted
- 20 Feb 2002
- Last updated
- 17 Nov 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Open Label, Two Part, Dose Escalation Study to Determine the Tolerability of Interferon-Beta Gene Transfer (BG00001) in the Treatment of Recurrent or Progressive Grade III and Grade IV Gliomas
- ClinicalTrials.gov ID
- NCT00031083
- Acronym / sponsor ID
- C-1502
- Keywords
- Glioma, Brain Tumor, Adenovirus, Gene Therapy, Biogen
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- 2 Apr 2002 (actual)
- Study completion
- 10 Oct 2003 (actual)
- First posted
- 22 Feb 2002 (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.
In this study an investigational replication-defective, recombinant adenovirus expressing the interferon-beta gene (BG00001) will be directly injected into tumors, in patients with recurrent Grade III and Grade IV Gliomas, in order to deliver the hIFN-beta gene. The purpose of the study is to evaluate the safety and any harmful effects of injection of BG00001 into brain tumors. Also, this study will help determine whether the virus carrying the beta interferon gene will enter brain tumor cells and cause the cancer cells to die. This study will require one hospital admission for the actual procedure of drug administration. All other visits will be conducted on an out-patient basis
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Must be greater than or equal to 18 years of age.
- Subjects must have histologically proven GBM, AA, AMO, malignant astrocytoma NOS or gliosarcoma and recurrent or progressive tumor following prior treatment.
- Tumor must be amenable to radical resection, and resection must be clinically indicated.
- Must have an ECOG performance status of 0-2.
- Must be on anticonvulsant therapy, and must have therapeutic serum levels within 2 weeks prior to Day 1, if therapeutic levels are defined for the anticonvulsant being used.
Key exclusion criteria (23 listed)
- Abnormal blood tests exceeding any of the limits defined below:
- Brainstem, or optic chiasm involvement of tumor.
- Uncontrolled seizure disorder.
- History of a new diagnosis or treatment of an invasive malignancy other than Grade III or Grade IV Glioma within 5 years of enrollment. Curatively treated subjects with a history of basal cell or squamous cell carcinoma of the skin, superficial transitional cell carcinoma of the bladder, and non-invasive carcinoma of the uterine cervix are not excluded.
- Treatment with radiation therapy, including interstitial radiation or radiosurgery, must be completed at least 8 weeks prior to Day 1.
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 |
|---|---|---|
| Interferon-beta | Genetic | – |
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 17 Nov 2020.
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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.
Medical Director study director
Biogen
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Interferon-beta in people with Glioblastoma Multiforme and Anaplastic Astrocytoma, run by Biogen at 5 sites 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?
The sponsor lists 5 inclusion and 23 exclusion criteria. 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 17 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
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 17 Nov 2020.