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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00451022
First received: March 20, 2007
Last updated: October 4, 2014
Last verified: December 2013
  Purpose

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.


Condition
Vaccine

Study Type: Observational
Official Title: Follow-Up of Study Subjects Previously Enrolled in Immunotherapy Studies Utilizing Gene Transfer or Other Immunotherapeutic Agents

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 500
Study Start Date: September 2004
Detailed Description:

This protocol aims to provide long-term follow-up and continued use of research specimens of patients previously enrolled on gene transfer or other immunotherapy studies at the National Cancer Institute. Subjects will undergo an annual health history for up to 15 years.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:

Subjects who received poxviral vectors (vaccinia and/or fowlpox) or other vaccines utilizing gene transfer or any other immunotherapeutic agent through an LTIB affiliated trial at the National Cancer Institute. These studies include (but are not limited to): 00-C-0137, 00-C-0154, 02-C-0218, 03-C-0176, 04-C-0167, 04-C-0246, 05-C-0017, 05-C-0167, 05-C-0229, 07-C-0106, 07-C-0107, 07-C-0188, 08-C-0166, 09-C-0101, 11-C-0225,12-C-0056, 13-C-0146, 13-C-0153, 13-C-0095 and 14-C-0142. Upon termination of the above protocols, available stored specimens obtained in each of the protocols listed above will be transferred to this protocol for future research use.

EXCLUSION CRITERIA:

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00451022

Contacts
Contact: James L Gulley, M.D. (301) 496-4916 gulleyj@mail.nih.gov

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact National Cancer Institute Referral Office    (888) NCI-1937      
Sponsors and Collaborators
Investigators
Principal Investigator: James L Gulley, M.D. National Cancer Institute (NCI)
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00451022     History of Changes
Obsolete Identifiers: NCT01444963
Other Study ID Numbers: 040274, 04-C-0274
Study First Received: March 20, 2007
Last Updated: October 4, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Fowlpox
Vaccinia
PSA
CEA
MUC-1
Gene Therapy
Long Term Survivor
Research Specimen

ClinicalTrials.gov processed this record on October 19, 2014