Follow-up of Breast Cancer and Multiple Myeloma Patients Previously Enrolled in NIH Gene Therapy Studies
| Status: | Completed |
|---|---|
| Conditions: | Hematology |
| Therapuetic Areas: | Hematology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 3/27/2019 |
| Start Date: | March 6, 2003 |
| End Date: | May 20, 2014 |
Follow-Up Study of Breast Cancer and Multiple Myeloma Subjects Previously Enrolled in Retroviral Gene Transfer Studies
This study will provide follow-up evaluations of breast cancer or multiple myeloma patients
who received gene therapy (gene transfer) as part of their participation in an NIH protocol.
Gene therapy is a new technology, which may involve a permanent change in the patient s
genetic code. Therefore, although the risk of long-term harmful effects of this therapy is
very small, the Food and Drug Administration requires prolonged monitoring of patients health
status.
Patients previously enrolled in NIH protocols 96-C-0007, 93-C-0208, 92-C-0161, or 92-H-0057
will be followed under the current protocol. No further gene therapy will be provided in this
study.
Patients health status will be evaluated for an indefinite period of time, or as long as they
are willing to be monitored. They will provide a blood sample once a year and will be
interviewed about their health status twice a year for the first 5 years after gene therapy
and once a year thereafter. These procedures are done to look for the development of any
diseases such as cancer, neurological disorders, autoimmune or blood disorders that may be
related to side effects of the gene transfer.
who received gene therapy (gene transfer) as part of their participation in an NIH protocol.
Gene therapy is a new technology, which may involve a permanent change in the patient s
genetic code. Therefore, although the risk of long-term harmful effects of this therapy is
very small, the Food and Drug Administration requires prolonged monitoring of patients health
status.
Patients previously enrolled in NIH protocols 96-C-0007, 93-C-0208, 92-C-0161, or 92-H-0057
will be followed under the current protocol. No further gene therapy will be provided in this
study.
Patients health status will be evaluated for an indefinite period of time, or as long as they
are willing to be monitored. They will provide a blood sample once a year and will be
interviewed about their health status twice a year for the first 5 years after gene therapy
and once a year thereafter. These procedures are done to look for the development of any
diseases such as cancer, neurological disorders, autoimmune or blood disorders that may be
related to side effects of the gene transfer.
This Protocol aims to provide long-term follow-up of breast cancer and multiple myeloma
subjects previously receiving autologous primitive marrow and blood hematopoietic cells
exposed to gene transfer retroviral vectors on the following protocols: MB 294 (92-C-0161;
T-92-0018), MB 310 (93-C-0208; T-92-0192), MB 361 (96-C-0007; T-95-0096) or (92-H-0057;
T-92-0139) at the National Cancer Institute and the National Heart, Lung, and Blood
Institute. Subjects will undergo an annual health history and annual complete blood counts
will be performed. Blood samples will also be collected annually (either locally or off-site
by the subjects' personal physicians) for testing for presence of the gene transfer vector
and vector integration sites.
subjects previously receiving autologous primitive marrow and blood hematopoietic cells
exposed to gene transfer retroviral vectors on the following protocols: MB 294 (92-C-0161;
T-92-0018), MB 310 (93-C-0208; T-92-0192), MB 361 (96-C-0007; T-95-0096) or (92-H-0057;
T-92-0139) at the National Cancer Institute and the National Heart, Lung, and Blood
Institute. Subjects will undergo an annual health history and annual complete blood counts
will be performed. Blood samples will also be collected annually (either locally or off-site
by the subjects' personal physicians) for testing for presence of the gene transfer vector
and vector integration sites.
- INCLUSION CRITERIA:
Subjects who received gene transfer products on the following protocols: MB 361, 96-C-0007,
T-95-0096; MB 294, 92-C-0161, T-92-0018; MB 310, 93-C 0208, T-92-0192; or 92-H-0057,
T-92-0139.
EXCLUSION CRITERIA:
Patients unwilling to participate.
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
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