Interferon-Beta Gene Transfer (Ad.hIFN-β) as Treatment for Refractory Colorectal Carcinoma With Liver Metastases

This study has been completed.
Sponsor:
Information provided by:
Biogen
ClinicalTrials.gov Identifier:
NCT00107861
First received: April 11, 2005
Last updated: July 10, 2009
Last verified: July 2009

April 11, 2005
July 10, 2009
May 2005
Not Provided
- Evaluate the safety of a single IV administration of Ad.hIFN-β.
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Complete list of historical versions of study NCT00107861 on ClinicalTrials.gov Archive Site
  • 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.
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Interferon-Beta Gene Transfer (Ad.hIFN-β) as Treatment for Refractory Colorectal Carcinoma With Liver Metastases
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.

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.

Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Colorectal Carcinoma
  • Metastases
Drug: Ad.hIFN-β (BG00001, IDEC-201)
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
44
September 2006
Not Provided

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00107861
201-20
Not Provided
Study MD
Biogen
Not Provided
Not Provided
Biogen
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP