Trial Outcomes & Findings for Study of Repeat Intranodal Injections of Ad-ISF35 (NCT NCT00942409)

Last Updated: 2015-12-30

Results Overview

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

5 participants

Primary outcome timeframe

2 Years

Results posted on

2015-12-30

Participant milestones
Measure	Ad-ISF35 Ad-ISF35, intranodal injection, 3.3 x 10\^10 ISF35 viral particles, every 2-4 weeks up to six total injections. ISF35: Subjects participating in this study will be treated with multiple doses of Ad-ISF35 given via intranodal injection using a fixed dose of 3.3 x 10\^10 ISF35 viral particles. Intranodal injections will be administered every 2-4 weeks up to six total injections.
Overall Study STARTED	5
Overall Study COMPLETED	2
Overall Study NOT COMPLETED	3

Reasons for withdrawal
Measure	Ad-ISF35 Ad-ISF35, intranodal injection, 3.3 x 10\^10 ISF35 viral particles, every 2-4 weeks up to six total injections. ISF35: Subjects participating in this study will be treated with multiple doses of Ad-ISF35 given via intranodal injection using a fixed dose of 3.3 x 10\^10 ISF35 viral particles. Intranodal injections will be administered every 2-4 weeks up to six total injections.
Overall Study Lack of Efficacy	1
Overall Study study drug unavailable	2

Study of Repeat Intranodal Injections of Ad-ISF35

Baseline characteristics by cohort
Measure	Ad-ISF35 n=5 Participants Ad-ISF35, intranodal injection, 3.3 x 10\^10 ISF35 viral particles, every 2-4 weeks up to six total injections. ISF35: Subjects participating in this study will be treated with multiple doses of Ad-ISF35 given via intranodal injection using a fixed dose of 3.3 x 10\^10 ISF35 viral particles. Intranodal injections will be administered every 2-4 weeks up to six total injections.
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=93 Participants
Age, Categorical >=65 years	4 Participants n=93 Participants
Sex: Female, Male Female	1 Participants n=93 Participants
Sex: Female, Male Male	4 Participants n=93 Participants
Region of Enrollment United States	5 participants n=93 Participants

Timeframe: 2 Years

Population: The study was not completed due to unavailability of the study drug, and therefore data were not collected for this Outcome Measure

Outcome data not reported

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Adverse event data not reported

Other adverse events
Measure	Ad-ISF35 n=5 participants at risk Ad-ISF35, intranodal injection, 3.3 x 10\^10 ISF35 viral particles, every 2-4 weeks up to six total injections. ISF35: Subjects participating in this study will be treated with multiple doses of Ad-ISF35 given via intranodal injection using a fixed dose of 3.3 x 10\^10 ISF35 viral particles. Intranodal injections will be administered every 2-4 weeks up to six total injections.
General disorders Hyponatremia	20.0% 1/5
General disorders Anorexia/Early satiety	100.0% 5/5
General disorders Chills	100.0% 5/5
General disorders Fatigue	100.0% 5/5
General disorders Fever	100.0% 5/5
Immune system disorders Flu like Syndrome	100.0% 5/5
Immune system disorders Injection site reaction	100.0% 5/5
Gastrointestinal disorders Nausea	100.0% 5/5
General disorders Sweating	100.0% 5/5
Gastrointestinal disorders Vomiting	80.0% 4/5
General disorders Weight loss	80.0% 4/5
General disorders Cough	60.0% 3/5
Gastrointestinal disorders Constipation	40.0% 2/5
Renal and urinary disorders Hematuria	40.0% 2/5

University of California, San Diego

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