Stem Cell Transplantation in Patients With High-Risk and Recurrent Pediatric Sarcomas

PHASE2CompletedINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

September 19, 2002

Primary Completion Date

May 1, 2009

Study Completion Date

December 14, 2011

Conditions
Sarcoma
Interventions
DRUG

F-18 Fluorodeoxyglucose

BIOLOGICAL

therapeutic allogeneic lymphocytes

Lymphocyte cells are collected from a healthy donor by apheresis and infused into the patient with a central venous catheter.

DRUG

cyclophosphamide

"Induction - 750 mg/m\^2 intravenous (IV) infusion over 30 minutes x 1 dose. Day 5.~Transplant - 1200 mg/m\^2 per day IV infusion over 2 hours daily for 4 days; days -6, -5, -4, -3."

DRUG

cyclosporine

6 mg/kg per dose orally every other day (no day 9 dose).

DRUG

doxorubicin hydrochloride

Induction - 10 mg/m\^2 per day continuous intravenous (IV) infusion over 24 hours daily for 4 days. Days 1, 2, 3, 4.

DRUG

etoposide

50 mg/m\^2 per day continuous intravenous (IV) infusion over 24 hours daily for 4 days. Days 1, 2, 3, 4.

DRUG

fludarabine phosphate

"Induction - 25 mg/m\^2 per day intravenous (IV) infusion over 30 minutes daily for 3 days. Days 1, 2, 3.~Transplant - 30 mg/m\^2 per day IV infusion over 30 minutes daily for 4 days; days -6, -5, -4, -3."

DRUG

melphalan

Transplant - 100 mg/m\^2 per day intravenous (IV) infusion over 15 minutes for 1 day; day -2.

DRUG

prednisone

Induction - 60 mg/m\^2 per day in 2-4 divided doses by mouth daily for 5 days; days 1, 2, 3, 4, 5.

DRUG

sirolimus

Initiated on day +3. Patients \>40kg, the initial dose will be 2 mg every 24 hours orally. Patients \<40 kg, the initial dose will be 1 mg/m\^2.

DRUG

tacrolimus

Day -1 at least 24 hours before the stem cell infusion at a dose of 0.03 mg/kg/day as a continuous infusion. Twelve hours later oral dose initiated at a dose of 0.1-0.15 mg/kg/day in two divided doses every 12 hours.

DRUG

vincristine sulfate

Induction - 0.4 mg/m\^2 per day continuous intravenous (IV) infusion over 24 hours daily for 4 days; 1, 2, 3, 4.

PROCEDURE

peripheral blood stem cell transplantation

Stem cells from a healthy donor are collected and transplanted into the patient using a central venous catheter.

DRUG

Filgrastim

PROCEDURE

Peripheral Blood Stem Cell donation

Trial Locations (1)

20892

National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda

All Listed Sponsors
lead

National Cancer Institute (NCI)

NIH

NCT00043979 - Stem Cell Transplantation in Patients With High-Risk and Recurrent Pediatric Sarcomas | Biotech Hunter | Biotech Hunter