Clinical trial · Observational
Follow-up of Breast Cancer and Multiple Myeloma Patients Previously Enrolled in NIH Gene Therapy Studies
Follow-Up Study of Breast Cancer and Multiple Myeloma Subjects Previously Enrolled in Retroviral Gene Transfer Studies
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gene Transfer | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
* 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.
References
Publications (3)
- BACKGROUNDDunbar CE, Cottler-Fox M, O'Shaughnessy JA, Doren S, Carter C, Berenson R, Brown S, Moen RC, Greenblatt J, Stewart FM, et al. Retrovirally marked CD34-enriched peripheral blood and bone marrow cells contribute to long-term engraftment after autologous transplantation. Blood. 1995 Jun 1;85(11):3048-57. PMID 7538814
- BACKGROUNDCowan KH, Moscow JA, Huang H, Zujewski JA, O'Shaughnessy J, Sorrentino B, Hines K, Carter C, Schneider E, Cusack G, Noone M, Dunbar C, Steinberg S, Wilson W, Goldspiel B, Read EJ, Leitman SF, McDonagh K, Chow C, Abati A, Chiang Y, Chang YN, Gottesman MM, Pastan I, Nienhuis A. Paclitaxel chemotherapy after autologous stem-cell transplantation and engraftment of hematopoietic cells transduced with a retrovirus containing the multidrug resistance complementary DNA (MDR1) in metastatic breast cancer patients. Clin Cancer Res. 1999 Jul;5(7):1619-28. PMID 10430060
- BACKGROUNDEmmons RV, Doren S, Zujewski J, Cottler-Fox M, Carter CS, Hines K, O'Shaughnessy JA, Leitman SF, Greenblatt JJ, Cowan K, Dunbar CE. Retroviral gene transduction of adult peripheral blood or marrow-derived CD34+ cells for six hours without growth factors or on autologous stroma does not improve marking efficiency assessed in vivo. Blood. 1997 Jun 1;89(11):4040-6. PMID 9166843