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| Sponsor: | National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Institutes of Health Clinical Center (CC) |
| ClinicalTrials.gov Identifier: | NCT00451022 |
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:
If a participant has died, the study will document the cause of death and autopsy information if available.
| Condition |
|---|
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Vaccine |
| Study Type: | Observational |
| Official Title: | Follow-Up of Study Subjects Previously Enrolled in Immunotherapy Studies Utilizing Gene Transfer |
| Estimated Enrollment: | 250 |
| Study Start Date: | September 2004 |
This protocol aims to provide long-term follow-up and continued use of research specimens of patients previously enrolled on gene transfer 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 |
Subjects who received poxviral vectors (vaccinia and/or fowlpox) or other vaccines utilizing gene transfer 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 and 04-C-0246, 05-C-0017, 05-C-0167, 05-C-0229, 07-C-0106, 07-C-0107, 07-C-0188, 08-C-0166, and 09-C-0101. 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| Contact: NCI Referral Office | 1-888-NCI-1937 |
| United States, Maryland | |
| National Institutes of Health Clinical Center, 9000 Rockville Pike | Recruiting |
| Bethesda, Maryland, United States, 20892 | |
| Sub-Investigator: National Cancer Institute Referral Office For more information at the NIH Clinical Center contact | |
More Information
| 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: | December 29, 2011 |
| Health Authority: | United States: Federal Government |
|
Fowlpox Vaccinia PSA CEA |
MUC-1 Gene Therapy Long Term Survivor Research Specimen |