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Follow-Up Study of Breast Cancer and Multiple Myeloma Subjects Previously Enrolled in Retroviral Gene Transfer Studies


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Open (Enrolling)
Both
Gene Transfer

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Trial Information

Follow-Up Study of Breast Cancer and Multiple Myeloma Subjects Previously Enrolled in Retroviral Gene Transfer Studies


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.

Inclusion Criteria


- 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.

Type of Study:

Observational

Study Design:

N/A

Principal Investigator

Ronald E Gress, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Cancer Institute (NCI)

Authority:

United States: Federal Government

Study ID:

030124

NCT ID:

NCT00427726

Start Date:

March 2003

Completion Date:

Related Keywords:

  • Gene Transfer
  • Gene Transfer
  • Hematopoietic Stem Cells
  • Follow-Up
  • Breast Neoplasms
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location

National Institutes of Health Clinical Center, 9000 Rockville PikeBethesda, Maryland  20892