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

NCT00107861 | Completed Phase 1

• 1 other identifier: 201-20
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 2

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.

Conditions

Colorectal Carcinoma; Metastases

Outcome Measures

Primary Outcomes (1)

• - 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.

Interventions

Ad.hIFN-β (BG00001, IDEC-201) DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Biogen: lead

Study Sites (2)

University of California San Diego

La Jolla, California, 92037, United States

Location

Mary Crowley Medical Research Center

Dallas, Texas, 75201, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 11, 2005
• First Posted: April 12, 2005
• Study Start: May 1, 2005
• Study Completion: September 1, 2006
• Last Updated: July 14, 2009

Record last verified: 2009-07

Locations

US (2)