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

• Status: Completed
• Trial end date: 2006-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Biogen
• Treatments: Interferon-beta; Interferons

Criteria

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.