Trial Information

A Phase I Pilot Study of Tumor Cell - B Lymphoblastoid Cell Line Vaccination in Pediatric Subjects With Relapsed Ewing's Sarcoma and Neuroblastoma

OBJECTIVES:

- Determine the safety of vaccination comprising autologous tumor cells fused with
Epstein-Barr virus-transformed B-lymphoblastoid cells followed by interleukin-2 (IL-2)
in children with relapsed or refractory Ewing's sarcoma or neuroblastoma.

- Determine antitumor immunity by examining cell phenotype and function in patients
treated with this vaccine and cytotoxic T lymphocytes (CTL).

- Determine the safety of CTL and IL-2 in these patients.

OUTLINE: This is a pilot study.

Tumor cells and blood cells are collected from patients and expanded in vitro. Tumor cells
and Epstein-Barr virus-transformed B-lymphoblastoid cells (derived from blood cells) are
fused together to produce the vaccine.

- Vaccination: Patients receive vaccine comprising autologous tumor cells fused with
Epstein-Barr virus-transformed B-lymphoblastoid cells subcutaneously (SC) once on days
0, 14, and 28 and interleukin-2 (IL-2) SC twice daily on days 1-7, 15-21, and 29-35.

- Cytotoxic T lymphocytes (CTL): After vaccination, patients with evidence of antitumor
immunity undergo leukapheresis to collect white blood cells for CTL expansion. Some of
these patients then receive CTL IV once on days 0, 14, and 28 and IL-2 SC twice daily
on days 1-7, 15-21, and 29-35.

Patients are followed weekly for 2 weeks, every 2 weeks for 1 month, monthly for 3 months,
and then every 2 months for up to 1 year post-vaccination. Patients who receive CTL are also
followed annually for survival.

PROJECTED ACCRUAL: A total of 10 patients will be accrued for this study within 3 years.