Allogeneic Tumor Cell Vaccination With Oral Metronomic Cytoxan in Patients With High-Risk Neuroblastoma

PHASE1/PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

11

Participants

Timeline

Start Date

September 30, 2010

Primary Completion Date

July 31, 2012

Study Completion Date

September 30, 2026

Conditions
Neuroblastoma
Interventions
BIOLOGICAL

Neuroblastoma Vaccine (unmodified SKNLP, with gene-modified SJNB-JF-IL2 and SJNB-JF-LTN neuroblastoma cells

"1x10\^7cells/m2 each of unmodified SKNLP, with gene-modified SJNB-JF-IL2 and SJNB-JF-LTN neuroblastoma cells will be given by subcutaneous injection while suspended in Ringers solution with 5% HSA in a single syringe in a volume of up to 1 ml.~Vaccines will be given on day 0 of week 0 and then on day 0 (+ 72 hours) of weeks 2, 4, 6, 9, 12, 16, 20.~Cells will be administered as a subcutaneous injection over 1 minute using a 21-gauge needle. Procedural pain control methods may be used per institutional protocol."

DRUG

Cytoxan

Metronomic oral cytoxan will start 72 hours prior to the first vaccination at a dose of 50 mg/m2/day. Cytoxan will be held on the day of vaccine administration and for the next 96 hours. After the first vaccine, patients will take 25 mg/m2/day as outlined on the roadmap.

Trial Locations (1)

77030

Texas Children's Hospital, Houston

All Listed Sponsors
collaborator

Center for Cell and Gene Therapy, Baylor College of Medicine

OTHER

lead

Baylor College of Medicine

OTHER

NCT01192555 - Allogeneic Tumor Cell Vaccination With Oral Metronomic Cytoxan in Patients With High-Risk Neuroblastoma | Biotech Hunter | Biotech Hunter