Follow Up Protocol for Subjects Previously Enrolled on NCI Surgery Branch Studies

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

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INCLUSION CRITERIA:
- Age greater than or equal to 18 years.

- Participants who have received treatment on an NCI-SB protocol, including gene therapy protocols.

(Note: Participants may be enrolled on this protocol and, at the same time, participate in an active treatment study).

- For Cohort A:Ability of participant or Legally Authorized Representative (LAR) to understand and the willingness to sign a written informed consent document.

For Cohort B: Participant is able to provide informed consent.

INCLUSION CRITERIA:

-For Cohort B: Women of child-bearing potential who are pregnant or plan to become pregnant because of the potentially dangerous effects of the investigational treatments administered on NCI-SB treatment protocols.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT00923026
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	National Cancer Institute (NCI)
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Steven A Rosenberg, M.D.
Principal Investigator Affiliation	National Cancer Institute (NCI)
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	NIH
Overall Status	Enrolling by invitation
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Melanoma, Adenocarcinoma, Carcinoma NOS, Neuroendocrine Tumors
Study Website:	View Trial Website

Additional Details

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.

Arms & Interventions

Arms

: A/Gene Therapy

Patients who have received gene therapy

: B/Non-Gene Therapy

Patients who have not received gene therapy

Interventions

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Bethesda, Maryland

Status

Address

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892

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