Background:
The NCI Surgery Branch has developed experimental therapies that involve taking white
blood cells from participants' tumor or from their blood, growing them in the laboratory
in large numbers, and then giving the cells back to the patient.
Objective:
This study will allow participants to be followed for up to 15 years following treatment
on an NCI Surgery Branch Gene Therapy Trial as required by the FDA.
Eligibility:
Participants must have been enrolled on an NCI Surgery Branch Gene Therapy Protocol
Design
Participants will be followed with a physical examination and blood tests for up to 15
years as required by the FDA
...
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT00923026.
Locations matching your search criteria
United States
Maryland
Bethesda
National Institutes of Health Clinical CenterStatus: Enrolling By Invitation
Contact: National Cancer Institute Referral Office
Phone: 888-624-1937
Background:
- Patients receiving care at the NIH Clinical Center are required to be enrolled on a
clinical protocol.
- Following participation in a treatment protocol, it may be in the best interest of
the patient to continue to be followed at the Clinical Center.
- The National Cancer Institute Surgery Branch (NCI-SB) conducts clinical trials
utilizing gene transfer. The current U.S. Food and Drug Administration (FDA)
requirements for long-term follow-up are up to fifteen years for some products. As
this time-period is frequently longer than studies are expected to be open, a
long-term follow-up protocol is necessary to ensure the follow-up of these
participants.
Objective:
-Primary objective:
--Provide a mechanism for long-term follow-up of participants who have participated in
research studies in the NCI-SB.
Eligibility:
- Age greater than or equal to 18 years.
- Participant has been enrolled on an NCI-SB treatment protocol.
Design:
- Participant will undergo physical exams, laboratory evaluation, imaging, or phone
follow-up as clinically indicated.
- Procedures that entail more than minimal risk to the patient should not be performed
for research purposes on this protocol.
Trial PhaseNo phase specified
Trial TypeNot provided by clinicaltrials.gov
Lead OrganizationNational Cancer Institute
Principal InvestigatorSteven A. Rosenberg
