NCT00451022

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

Recruiting now Last updated 7 April 2026

What this trial tests

trial in Prostate Cancer in 750 participants. Currently enrolling.

Timeline

13 September 2004

Quick facts

Lead sponsor	National Cancer Institute (NCI)
Status	Recruiting now
Study type	OBSERVATIONAL
Enrollment	750
Start date	13 September 2004
Sites	1 location across United States

Conditions studied

• Prostate Cancer — all drugs for Prostate Cancer →
• Liver Cancer — all drugs for Liver Cancer →
• Breast Cancer — all drugs for Breast Cancer →
• Colon Cancer — all drugs for Colon Cancer →

Sponsor

National Cancer Institute (NCI)

Who can join

18 and older, any sex, with Prostate Cancer or Liver Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Emerging Immunotherapy Approaches for Treating Prostate Cancer.
   Meng L, Yang Y, Mortazavi A, Zhang J. · · 2023 · cited 25× · PMID 37762648 · DOI 10.3390/ijms241814347
2. Novel Combination Immunotherapy and Clinical Activity in Patients With HPV-Associated Cancers: A Nonrandomized Clinical Trial.
   Floudas CS, Goswami M, Donahue RN, Pastor DM, et al · · 2025 · cited 14× · PMID 39976981 · DOI 10.1001/jamaoncol.2024.6998
3. Gene therapy for people with hepatocellular carcinoma.
   Naing C, Ni H, Aung HH, Htet NH, et al · · 2024 · cited 8× · PMID 38837373 · DOI 10.1002/14651858.cd013731.pub2
4. PRGN-2009 and bintrafusp alfa for patients with advanced or metastatic human papillomavirus-associated cancer.
   Floudas CS, Goswami M, Donahue RN, Strauss J, et al · · 2025 · cited 5× · PMID 40116923 · DOI 10.1007/s00262-025-04009-z
5. Microorganisms and Breast Cancer: An In-Depth Analysis of Clinical Studies.
   Naderi N, Mosahebi A, Williams NR. · · 2023 · cited 2× · PMID 38276152 · DOI 10.3390/pathogens13010006