Vaccine Therapy and Interleukin-2 in Treating Young Patients With Relapsed or Refractory Ewing's Sarcoma or Neuroblastoma

Penn State Health

Status and phase

Unknown

Phase 1

Conditions

Sarcoma

Neuroblastoma

Treatments

Biological: aldesleukin

Biological: autologous EBV-transformed B lymphoblastoid-tumor fusion cell vaccine

Biological: therapeutic autologous lymphocytes

Study type

Interventional

Funder types

Other

Identifiers

NCT00101309

CDR0000404366

PSCI-18990

Details and patient eligibility

About

RATIONALE: Vaccines made from a person's tumor cells and white blood cells may make the body build an effective immune response to kill tumor cells. Interleukin-2 (IL-2) may stimulate the white blood cells to kill tumor cells. Biological therapies, such as cellular adoptive immunotherapy, stimulate the immune system and stop tumor cells from growing. Giving vaccine therapy with IL-2 may be a more effective treatment for Ewing's sarcoma or neuroblastoma.

PURPOSE: This phase I trial is studying the side effects of vaccine therapy when given with IL-2 in treating young patients with relapsed or refractory Ewing's sarcoma or neuroblastoma.

Full description

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.

Enrollment

10 estimated patients

Sex

All

Ages

1 to 30 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

Diagnosis of Ewing's sarcoma OR neuroblastoma
- Relapsed or refractory disease
Epstein-Barr virus positive

PATIENT CHARACTERISTICS:

Age

1 to 30

Performance status

Lansky 70-100% OR
ECOG 0-2

Life expectancy

At least 8 weeks

Hepatic

Bilirubin < 2.0 mg/dL
AST and ALT < 2.5 times normal (in the absence of liver metastases)
- Patients without evidence of an obvious relationship between AST/ALT and disease activity are not eligible
Hepatitis B antigen and core antibody negative
Hepatitis C antibody negative

Renal