Mini Allo Stem Cell Transplantation for the Treatment of Solid Tumors

NACompletedINTERVENTIONAL
Enrollment

14

Participants

Timeline

Start Date

November 30, 2000

Primary Completion Date

November 30, 2007

Study Completion Date

June 30, 2010

Conditions
Metastatic Solid Tumor
Interventions
DRUG

nonmyeloablative stem cell transplant

Conditioning includes cytoxan 60mg/kg/d on Days 6 \& 5, total dose 120mg/kg, Fludarabine 25mg/m2/d on days -5 to -1, total dose 125mg/m2. Patients with decreased cardiac or liver function pre-transplant will have their dose of cytoxan reduced by 25% - 45 mg/kg/d for 2 days or total dose of 90mg/kg. Patients will receive G-CSF (5ug/kg) to foster engraftment. PBSC progenitors will be mobilized from donor with G-CSF 5ug/kg 2x daily starting 4 days prior to stem cell collection until a target of 5-10 x106 CD34+ cells/kg is reached. Peripheral blood progenitors will be isolated from leukaphereses obtained on Days 5 \& 6 with additional collections dependent on cell yields. Peripheral blood from donors will be given to patients 1 day after cytoreduction \& immunosuppression. Immunosuppression will be tapered Day +60 if no signs of GVHD. Patients with residual non-regressing disease or mixed chimerism after day 100, who are off immunosuppression \& do not have signs of GVHD, will receive a DLI

Trial Locations (1)

02115

Beth Israel Deaconess Medical Center, Boston

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Amgen

INDUSTRY

lead

Beth Israel Deaconess Medical Center

OTHER

NCT00997529 - Mini Allo Stem Cell Transplantation for the Treatment of Solid Tumors | Biotech Hunter | Biotech Hunter