Follow Up Protocol for Subjects Previously Enrolled in NCI Surgery Branch Studies
| Status: | Recruiting |
|---|---|
| Conditions: | Skin Cancer, Cancer, Brain Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - 120 |
| Updated: | 1/10/2019 |
| Start Date: | June 3, 2009 |
| Contact: | Steven A Rosenberg, M.D. |
| Email: | IRC@nih.gov |
| Phone: | (240) 858-3080 |
Background:
The NCI Surgery Branch has developed experimental therapies that involve taking white blood
cells from patients' 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 patients to be followed for up to 15 years following treatment on an
NCI Surgery Branch Gene Therapy Trial as required by the FDA.
Eligibility:
Patients must have been enrolled on an NCI Surgery Branch Gene Therapy Protocol
Design
Patients will be followed with a physical examination and blood tests for up to 15 years as
required by the FDA
The NCI Surgery Branch has developed experimental therapies that involve taking white blood
cells from patients' 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 patients to be followed for up to 15 years following treatment on an
NCI Surgery Branch Gene Therapy Trial as required by the FDA.
Eligibility:
Patients must have been enrolled on an NCI Surgery Branch Gene Therapy Protocol
Design
Patients will be followed with a physical examination and blood tests for up to 15 years as
required by the FDA
BACKGROUND:
- Patients receiving care at the NIH Clinical Center are required to be enrolled in 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 NCI Surgery Branch conducts clinical trials utilizing gene transfer. The current 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 protocol is
necessary to ensure the necessary follow up of these subjects
OBJECTIVES:
-To provide long term follow up of patients previously enrolled on treatment protocols in the
NCI Surgery Branch
ELIGIBILITY:
-Enrollment on an NCI Surgery Branch treatment protocol
DESIGN:
-Patients will undergo physical exams, laboratory evaluation, imaging or phone follow up as
required by the treatment protocol and/or as clinically indicated.
- Patients receiving care at the NIH Clinical Center are required to be enrolled in 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 NCI Surgery Branch conducts clinical trials utilizing gene transfer. The current 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 protocol is
necessary to ensure the necessary follow up of these subjects
OBJECTIVES:
-To provide long term follow up of patients previously enrolled on treatment protocols in the
NCI Surgery Branch
ELIGIBILITY:
-Enrollment on an NCI Surgery Branch treatment protocol
DESIGN:
-Patients will undergo physical exams, laboratory evaluation, imaging or phone follow up as
required by the treatment protocol and/or as clinically indicated.
- INCLUSION CRITERIA:
- Subjects who have received treatment on an NCI Surgery Branch protocol, including gene
therapy protocols.
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
Phone: 866-820-4505
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