Colorectal Carcinoma, Metastases
Conditions
Brief 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 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.
Interventions
DRUGAd.hIFN-β (BG00001, IDEC-201)
Sponsors
Biogen
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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. * 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.
Exclusion criteria
* 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. * 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Evaluate the safety of a single IV administration of Ad.hIFN-β. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
United States
Outcome results
None listed