Colorectal CarcinomaPhase 1/2NCT00107861
Interferon-Beta Gene Transfer (Ad.hIFN-β) as Treatment for Refractory Colorectal Carcinoma With Liver Metastases
A Phase 1/2 study testing Ad.hIFN-β (BG00001, IDEC-201) in people with Colorectal Carcinoma and Metastases, run by Biogen at 2 sites in United States.
Trial summary
This study will be conducted in subjects with refractory colorectal carcinoma with unresectable liver metastases. The purposes of the study are: to evaluate the safety and any harmful effects of an intravenous injection of Ad.hIFN-β; help determine whether the virus carrying the interferon-beta gene will enter the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Carcinoma, Metastases
- What is being tested?
- Ad.hIFN-β (BG00001, IDEC-201)
- How many people
- 44 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2005to Sep 2006
- Phase
- Phase 1/2
- 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
- Subjects with histologically confirmed hepatic metastases from primary colorectal carcinoma.
- Not amenable to complete surgical resection for attempted cure as determined by the Principal Investigator (PI).
- Tumor progression after prior therapy for colorectal carcinoma, including fluoropyrimidine (5 FU or capecitabine), irinotecan, oxaliplatin, or cetuximab.
- One or more metastatic hepatic tumors that is measurable on CT scan. In addition, subjects may have nonhepatic metastatic tumors.
- ECOG performance status of ≤ 1.
- Age ≥ 18 years.
Show all 18Show fewer
- Signed, written IRB-approved informed consent.
- Men and women of reproductive potential must be willing to follow accepted birth control methods during treatment and for 3 months after completion of treatment.
- Acceptable liver function:
- Bilirubin ≤ 1.5 x upper limit of normal;
- AST, ALT ≤ 2.0 x upper limit of normal;
- Albumin ≤ 3.0 g/dL.
- Acceptable hematologic status:
- Granulocyte ≥ 1000 cells/mm3;
- Platelet count ≥ 150,000 plts/mm3;
- Hemoglobin > 9 g/dL.
- Acceptable coagulation status: INR within normal limits.
- Acceptable kidney function: Serum creatinine within normal limits.
Who cannot join
- New York Heart Association Class III or IV cardiac disease, myocardial infarction within the past 6 months prior to Day 1, unstable arrhythmia, or evidence of ischemia on ECG within 14 days prior to Day 1.
- Seizure disorders requiring anticonvulsant therapy.
- Severe chronic obstructive pulmonary disease with hypoxemia.
- Major surgery, other than diagnostic surgery, within 4 weeks prior to Day 1.
- Active uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy.
- Pregnant or nursing women.
Show all 14Show fewer
- Treatment with radiation therapy, surgery, chemotherapy, or investigational therapy within 1 month prior to study entry.
- Unwillingness or inability to comply with procedures required in this protocol.
- Known infection with HIV, hepatitis B, or hepatitis C.
- Serious nonmalignant disease (e.g., hydronephrosis, liver failure, or other conditions) that could compromise protocol objectives in the opinion of the investigator and/or the sponsor.
- Clinically significant bleeding event within the last 3 months, unrelated to trauma.
- More than 50% of liver replaced by tumor (estimated by the PI from CT scan within 14 days of Day 1).
- Previous treatment with Ad.hIFN-β.
- Any prior treatment with a gene delivery vector or an adenovirus therapeutic agent.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Mary Crowley Medical Research Center
Dallas, Texas, 75201
University of California San Diego
La Jolla, California, 92037
About this study
Official title: A Phase I/II Study of Interferon-Beta Gene Transfer (Ad.hIFN-β) in the Treatment of Refractory Colorectal Carcinoma With Liver Metastases
This study will be conducted in subjects with refractory colorectal carcinoma with unresectable liver metastases. The purposes of the study are:
- to evaluate the safety and any harmful effects of an intravenous injection of Ad.hIFN-β;
- help determine whether the virus carrying the interferon-beta gene will enter the bloodstream and liver tumor cells and cause the cancer cells to die.
Read the detailed description
This trial is a clinical research study of Ad.hIFN-β, an investigational, replication-defective, recombinant adenovirus containing the human interferon beta gene, for people that have refractory colorectal carcinoma with liver metastases. Scientists have been exploring a variety of approaches to develop medications to treat patients with refractory colorectal carcinoma with liver metastases; a disease for which current treatment provides only limited relief, so there is a need for new medications.
- Conditions
- Colorectal Carcinoma, Metastases
- Being tested
- Ad.hIFN-β (BG00001, IDEC-201)
- Medical subject headings
- Colorectal Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ad.hIFN-β (BG00001, IDEC-201)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
- Evaluate the safety of a single IV administration of Ad.hIFN-β.
Secondary outcomes (4)
Evaluate the MTD or maximum feasible dose (MFD) of Ad.hIFN-β.
Evaluate IFN-β and Ad.hIFN-β vector serum concentrations.
Evaluate immunogenicity of Ad.hIFN-β by measuring human anti adenovirus and human anti-IFN-β antibody formation.
Explore preliminary clinical activity.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2005 (estimated)
- Study startMay 2005
- Study completionSep 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CarcinomaStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 44 participants
Sponsor and investigators
- Lead sponsor
- Biogen
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00107861
- Sponsor's protocol ID
- 201-20
- Status last verified
- Jul 2009
- First submitted
- 11 Apr 2005
- Last updated
- 14 Jul 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Study of Interferon-Beta Gene Transfer (Ad.hIFN-β) in the Treatment of Refractory Colorectal Carcinoma With Liver Metastases
- ClinicalTrials.gov ID
- NCT00107861
- Acronym / sponsor ID
- 201-20
- Conditions
- Colorectal Carcinoma, Metastases
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- May 2005
- Study completion
- Sep 2006 (actual)
- First posted
- 12 Apr 2005 (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.
This study will be conducted in subjects with refractory colorectal carcinoma with unresectable liver metastases. The purposes of the study are:
- to evaluate the safety and any harmful effects of an intravenous injection of Ad.hIFN-β;
- help determine whether the virus carrying the interferon-beta gene will enter the bloodstream and liver tumor cells and cause the cancer cells to die.
Detailed description
This trial is a clinical research study of Ad.hIFN-β, an investigational, replication-defective, recombinant adenovirus containing the human interferon beta gene, for people that have refractory colorectal carcinoma with liver metastases. Scientists have been exploring a variety of approaches to develop medications to treat patients with refractory colorectal carcinoma with liver metastases; a disease for which current treatment provides only limited relief, so there is a need for new medications.
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 (18 listed)
- Subjects with histologically confirmed hepatic metastases from primary colorectal carcinoma.
- Not amenable to complete surgical resection for attempted cure as determined by the Principal Investigator (PI).
- Tumor progression after prior therapy for colorectal carcinoma, including fluoropyrimidine (5 FU or capecitabine), irinotecan, oxaliplatin, or cetuximab.
- One or more metastatic hepatic tumors that is measurable on CT scan. In addition, subjects may have nonhepatic metastatic tumors.
- ECOG performance status of ≤ 1.
Key exclusion criteria (14 listed)
- New York Heart Association Class III or IV cardiac disease, myocardial infarction within the past 6 months prior to Day 1, unstable arrhythmia, or evidence of ischemia on ECG within 14 days prior to Day 1.
- Seizure disorders requiring anticonvulsant therapy.
- Severe chronic obstructive pulmonary disease with hypoxemia.
- Major surgery, other than diagnostic surgery, within 4 weeks prior to Day 1.
- Active uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy.
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 |
|---|---|---|
| Ad.hIFN-β (BG00001, IDEC-201) | Drug | – |
Primary outcome
- Evaluate the safety of a single IV administration of Ad.hIFN-β.
4 secondary outcomes
Evaluate the MTD or maximum feasible dose (MFD) of Ad.hIFN-β.
Evaluate IFN-β and Ad.hIFN-β vector serum concentrations.
Evaluate immunogenicity of Ad.hIFN-β by measuring human anti adenovirus and human anti-IFN-β antibody formation.
Explore preliminary clinical activity.
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 14 Jul 2009.
Related trials for Colorectal Carcinoma
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer
Not yet recruitingPhase 2
Alberta Cancer Exercise Dose in Colorectal Cancer
Cancer, Colorectal Cancer
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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Ad.hIFN-β (BG00001, IDEC-201) in people with Colorectal Carcinoma and Metastases, run by Biogen at 2 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 18 inclusion and 14 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 14 Jul 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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.
What does the primary outcome measure?
- Evaluate the safety of a single IV administration of Ad.hIFN-β.. It is what the study was designed to measure, not a finding.
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 14 Jul 2009.