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Protocol Details

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

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

09-C-0161

Sponsoring Institute

National Cancer Institute (NCI)

Recruitment Detail

Type: Enrolling by Invitation
Gender: Male & Female
Min Age: 18 Years
Max Age: N/A

Referral Letter Required

Yes

Population Exclusion(s)

Children

Keywords

Gene Therapy;
Follow-Up;
Delayed Toxicity;
Natural History

Recruitment Keyword(s)

Adenocarcinoma;
Melanoma;
Neuroendocrine Tumors;
Carcinoma;
Follow-Up

Condition(s)

Melanoma;
Adenocarcinoma;
Carcinoma NOS;
Neuroendocrine Tumors

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Cancer Institute

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

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Eligibility

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.


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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

Steven A. Rosenberg, M.D.
National Cancer Institute (NCI)



NCI/Surgery Branch Recruitment Center
National Cancer Institute (NCI)
National Institutes of Health
Building 10
Room 2-1730
10 Center Drive
Bethesda, Maryland 20892
(866) 820-4505
irc@nih.gov

Recruitment Center - SB
National Institute of Health Clinical Center (CC), 9000 Rockville Pike, Building 10, Room 2-1730, Bethesda, Maryland 20892, United States
(866) 820-4505
ncisbirc@mail.nih.gov

Clinical Trials Number:

NCT00923026

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