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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT00451022
Recruitment Status : Recruiting
First Posted : March 22, 2007
Last Update Posted : November 8, 2017
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )

Brief 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.

Condition or disease

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 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.

Study Type : Observational
Estimated Enrollment : 750 participants
Official Title: Follow-Up of Study Subjects Previously Enrolled in Immunotherapy Studies Utilizing Gene Transfer or Other Immunotherapeutic Agents
Study Start Date : September 1, 2004

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
  • 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 Institute, as well as. subjects at extramural sites receiving these agents as part of a multi-site trial. 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-0095,14-C-0142, 14-C-0112,15-C-0205 11-C-0247, 11-C-0262, 13-C-0063, 14-C-0090, 15-C-0012, 15-C-0118, 15-C-0145, 15-C-0178, 15-C-0179, 16-C-0035, 16-C-0048, 16-C-0079, 17-C-0007, 17-C-0023, 17-C-0038, 17-C-0057, and 17-C-0061. Upon termination of the above protocols, available stored specimens obtained from NCI patients in each of the protocols listed above will be transferred to this protocol for future research use.
  • Subjects must be > 18 years of age.


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.)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00451022

Contact: Jennifer L Marte, M.D. (301) 496-7214

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
National Cancer Institute (NCI)
Principal Investigator: Jennifer L Marte, M.D. National Cancer Institute (NCI)

Additional Information:
Responsible Party: National Cancer Institute (NCI) Identifier: NCT00451022     History of Changes
Obsolete Identifiers: NCT01444963
Other Study ID Numbers: 040274
First Posted: March 22, 2007    Key Record Dates
Last Update Posted: November 8, 2017
Last Verified: October 30, 2017

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) ):
Gene Therapy
Long Term Survivor
Research Specimen