Follow-Up Study of Subjects Previously Enrolled in Poxviral Vector Gene Transfer Studies

Breast Cancer Clinical Trial

Official title:

Follow-Up Study of Subjects Previously Enrolled in Immunotherapy Studies Utilizing Gene Transfer or Other Immunotherapeutic Agents

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00451022
• Other study ID #: 040274
• Secondary ID: 04-C-0274
• Status: Recruiting
• Start date: September 13, 2004

Study information

• Verified date: June 3, 2024
• Source: National Institutes of Health Clinical Center (CC)
• Contact: Sheri A McMahon, R.N.
• Phone: (240) 760-7968
• Email: sheri.mcmahon[@]nih.gov
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study aims to provide long-term follow-up care of patients previously enrolled in a vaccine study that involved poxviral vectors. Vectors are sequences of genetic material that can be used to introduce specific genes into genetic makeup. The study does not involve the use of any drug or biologic agent. Participants will undergo an annual health history. Because certain viruses enter into cells and create proteins from the viral genes, the type of vaccine treatment used is referred to gene therapy. The genes expressed by poxviral vectors do not become part of the genetic material left behind. Because gene therapy is a somewhat new technology, a prolonged monitoring of patients' health status is necessary, according to new specific reporting requirements for harmful events in patients who undergo such gene therapy studies. The risk of any long-term negative effects from the gene therapy that patients had received is quite small. Still, it is important that there be updates at least annually. This annual monitoring of health status will extend for 15 years, according to guidelines from the Food and Drug Administration, or for as long as patients are willing to participate.

Patients who received poxviral vectors (vaccinia or fowlpox, or both) at the National Cancer Institute, through a trial affiliated with the Laboratory of Tumor Immunology and Biology, may be eligible for this study.

Participants will be involved in the following forms of data collection:

• Annual medical history and physical examinations for the first 5 years following the last vaccine.

• Annual telephone contact during the last 10 years.

• Health status check, including primary cancer status, secondary malignancies, neurologic disorders, autoimmune disorders, and hematologic disorders.

• Blood tests for the presence of HIV antibodies.

• Reporting of medical problems, including information on unexpected hospitalizations and medications.

If a participant has died, the study will document the cause of death and autopsy information if available.

Description:

This protocol aims to provide long-term follow-up and continued use of research specimens of participants previously enrolled on gene transfer or other immunotherapy studies at the National Cancer Institute as well as follow-up of subjects at extramural sites receiving these agents as part of a multi-site trial. Subjects will undergo an annual health history for up to 15 years.

Other known NCT identifiers

• NCT01444963

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 750
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

• INCLUSION CRITERIA:

• Subjects who received poxviral vectors (vaccinia and/or fowlpox) or other vaccines utilizing gene transfer or any other immunotherapeutic agent through GMB, UOB and LTIB affiliated trials at the National Cancer Institute, as well as subjects at extramural sites receiving these agents as part of a multi-site trial. Available stored specimens obtained from NCI participants in GMB, UOB, and LTIB affiliated protocols may be transferred to this protocol for storage and eventual future research use.

• Subjects must be >= 18 years of age.

EXCLUSION CRITERIA:

Participants unwilling to participate.

(Please note, participants may participate in this protocol and, at the same time, participate in an active treatment or continuing care study.)

Related Conditions & MeSH terms

• Breast Cancer
• Colon Cancer
• Liver Cancer
• Liver Neoplasms
• Lung Cancer
• Prostate Cancer

Locations

Country	Name	City	State
United States	National Institutes of Health Clinical Center	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To provide a mechanism for adequate follow-up of subjects previously participating in gene transfer or other immunotherapy studies at the National Cancer Institute as required by the U.S. Food and Drug Administration.	Annual history and physical examinations for the first 5 years of follow-up and an annual telephone contact during the next 10 years.	on-going
Primary	To facilitate the continuous usage of stored research specimens collected from subjects under completed and ongoing protocols.	Continued analysis on stored specimen samples until the samples are completely used.	on-going

External Links

•   NIH Clinical Center Detailed Web Page