Protocol Number: 04-C-0274

Title:

Follow-Up of Study Subjects Previously Enrolled in Immunotherapy Studies Utilizing Gene Transfer

Number:

04-C-0274

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.

Sponsoring Institute:

National Cancer Institute (NCI)

Recruitment Detail

Type: Participants currently recruited/enrolled

Gender: Male & Female

Referral Letter Required: Yes

Population Exclusion(s): None

Eligibility Criteria:

INCLUSION CRITERIA:

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, 07-C-0106, and 07-C-0107.

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.)

Special Instructions:

Currently Not Provided

Keywords:

Fowlpox

Vaccinia

PSA

CEA

MUC-1

Recruitment Keyword(s):

None

Condition(s):

Vaccine

Investigational Drug(s):

None

Investigational Device(s):

None

Intervention(s):

None

Supporting Site:

National Cancer Institute

Contact(s):

NCI Referral Office
National Institute of Health Clinical Center (CC), 9000 Rockville Pike, Bethesda, Maryland 20892, United States: NCI Clinical Trials Referral Office
Phone: 1-888-NCI-1937
Fax: Not Listed
Electronic Address: ncicssc@mail.nih.gov

Citation(s): Not Provided

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
• Technical questions regarding the Clinical Center web site, please contact the Department of Clinical Research Informatics, CC.

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