Protocol Details

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

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number	04-C-0274
Sponsoring Institute	National Cancer Institute (NCI)
Recruitment Detail	Type: Participants currently recruited/enrolled Gender: Male & Female Min Age: 18 Years Max Age: N/A
Referral Letter Required	Yes
Population Exclusion(s)	Children; Fetuses; Pregnant Women; Neonates
Keywords	Gene Therapy; Long Term Survivor; Research Specimen; Natural History
Recruitment Keyword(s)	None
Condition(s)	Prostate Cancer; Liver Cancer; Breast Cancer; Colon Cancer; Lung Cancer
Investigational Drug(s)	None
Investigational Device(s)	None
Intervention(s)	None
Supporting Site	National Cancer Institute

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.

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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.)

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Citations:

Not Provided

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Contacts:

Principal Investigator	Referral Contact	For more information:
Jennifer L. Marte National Cancer Institute (NCI) National Institutes of Health Building 10 Room 13N208 10 Center Drive Bethesda, Maryland 20892 (301) 496-7214 martej@mail.nih.gov	Sheri A. McMahon, R.N. National Cancer Institute (NCI) National Institutes of Health Building 10 Room 13N254 10 Center Drive Bethesda, Maryland 20892 (240) 760-7968 sheri.mcmahon@nih.gov	NCI Referral Office National Institute of Health Clinical Center (CC), 9000 Rockville Pike, Bethesda, Maryland 20892, United States: NCI Clinical Trials Referral Office 1-888-NCI-1937 ncimo_referrals@mail.nih.gov

Clinical Trials Number:

NCT00451022

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