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Phase I Study of the Third Generation Adenovirus H5.001CBCFTR in Patients with Cystic Fibrosis



Phase I Study of the Third Generation Adenovirus H5.001CBCFTR in Patients with Cystic Fibrosis

For Condition: Cystic Fibrosis
Status: Completed
Sponsor(s): National Center for Research Resources (NCRR) , University of Pennsylvania
Synopsis: OBJECTIVES: I. Assess the safety and feasibility of gene transfer with the third generation adenovirus H5.001CBCFTR in patients with cystic fibrosis.
Details: PROTOCOL OUTLINE: H5.001CBCFTR, an adenovirus vector containing the cystic fibrosis transmembrane conductance regulator gene, is administered endobronchially. Cohort of 2 patients receive 1 of 6 H5.001CBCFTR concentrations. There is no intrapatient dose escalation.
Eligibility:
Study Type:  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Cystic fibrosis diagnosed as follows: Sweat sodium or chloride greater than 60 mEq/L by pilocarpine iontophoresis or cystic fibrosis genotype Clinical manifestations Estimated 2-year survival greater than 50%, i.e.: FEV1 at least 30% of predicted PaO2 greater than 55 mm Hg on room air PaCO2 less than 50 mm Hg on room air --Prior/Concurrent Therapy-- At least 2 months since systemic glucocorticoids At least 90 days since participation in investigational therapeutic study --Patient Characteristics-- Pulmonary: No pneumothorax within 12 months No asthma or allergic bronchopulmonary aspergillosis requiring glucocorticoids within 2 months No sputum pathogens unless sensitive to at least 2 antibiotics No hemoptysis of more than 250 mL blood over 24 hours within 1 year Other: No active adenoviral infection Ad5 (or similar type) antibody seropositive No other contraindication to protocol participation, e.g.: Drug abuse Alcoholism Psychiatric instability Inadequate motivation Documented azoospermia (men) Bilateral tubal ligation or hysterectomy (women) Screening exams within 4 weeks prior to registration
Total Enrollment: 14

Location and Contact Information:

Overall Study Official:
JamesWilson,  Study Chair,  University of Pennsylvania


Additional Information:
Study ID Numbers:  199/11715;  UPHS-28051
Study Start Date: November 1995
Record last reviewed: January 2000
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004287

Other Cystic Fibrosis Studies:
1. Studying Patients with Cystic Fibrosis and Other Pulmonary and Pancreatic Disorders

2. Safety and Efficacy Study of Nutropin AQ to Treat Growth Restriction in Children with Cystic Fibrosis

3. Weight Gain in CF

4. Phase I Study of the Third Generation Adenovirus H5.001CBCFTR in Patients with Cystic Fibrosis

5. Study of Ibuprofen to Preserve Lung Function in Patients with Cystic Fibrosis

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