The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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.
 
ClinicalTrials.gov Identifier: NCT00451022
Recruitment Status : Recruiting
First Posted : March 22, 2007
Last Update Posted : June 13, 2024
Sponsor:
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
Prostate Cancer Liver Cancer Breast Cancer Colon Cancer Lung Cancer

Detailed Description:
This protocol aims to provide long-term follow-up and continued use of research specimens of participants 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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 750 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Follow-Up Study of Subjects Previously Enrolled in Immunotherapy Studies Utilizing Gene Transfer or Other Immunotherapeutic Agents
Actual Study Start Date : September 13, 2004

Resource links provided by the National Library of Medicine


Group/Cohort
Cohort 1
Subjects previously participating in gene transfer or other immunotherapy studies at the NCI or extramural sites receiving therapeutic agents as part of a multi-site trial.



Primary Outcome Measures :
  1. To provide a mechanism for adequate follow-up of subjects previously participating in gene transfer or other immunotherapy studies at the National Cancer Institute as required by the U.S. Food and Drug Administration. [ Time Frame: on-going ]
    Annual history and physical examinations for the first 5 years of follow-up and an annual telephone contact during the next 10 years.

  2. To facilitate the continuous usage of stored research specimens collected from subjects under completed and ongoing protocols. [ Time Frame: on-going ]
    Continued analysis on stored specimen samples until the samples are completely used.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
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. These studies include (but are not limited to) the following NCI protocol numbers : 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-020511-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.
Criteria
  • 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.)


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 ClinicalTrials.gov identifier (NCT number): NCT00451022


Contacts
Layout table for location contacts
Contact: Sheri A McMahon, R.N. (240) 760-7968 sheri.mcmahon@nih.gov
Contact: Jennifer L Marte (301) 496-7214 martej@mail.nih.gov

Locations
Layout table for location information
United States, Maryland
National Institutes of Health Clinical Center Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)    800-411-1222 ext TTY dial 711    ccopr@nih.gov   
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
Layout table for investigator information
Principal Investigator: Jennifer L Marte National Cancer Institute (NCI)
Additional Information:
Layout table for additonal information
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00451022    
Obsolete Identifiers: NCT01444963
Other Study ID Numbers: 040274
04-C-0274
First Posted: March 22, 2007    Key Record Dates
Last Update Posted: June 13, 2024
Last Verified: June 3, 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: .All IPD recorded in the medical record will be shared with intramural investigators upon request.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: Clinical data available during the study and indefinitely.
Access Criteria: Clinical data will be made available via subscription to BTRIS and with the permission of the study PI.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) ):
Gene Therapy
Long Term Survivor
Research Specimen
Natural History
Additional relevant MeSH terms:
Layout table for MeSH terms
Liver Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Liver Diseases