This study is currently recruiting participants.
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)
Intervention(s)
Supporting Site
National Cancer Institute
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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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.
-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.
Principal Investigator
Referral Contact
For more information: