NCT00427726 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Cowan 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.
Dunbar 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.
Emmons 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.

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

Clinical trial NCT00427726 - References