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


Phase 1
1 Year
30 Years
Open (Enrolling)
Both
Neuroblastoma, Sarcoma

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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.

Inclusion 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

- Creatinine clearance > 50 mL/min

Immunologic

- HIV 1 and 2 negative

- HTLV 1 and 2 negative

Other

- Not pregnant

- Negative pregnancy test

- Fertile patients must use effective contraception

- No other moribund condition

PRIOR CONCURRENT THERAPY:

Biologic therapy

- At least 3 months since prior autologous stem cell transplantation

Chemotherapy

- Not specified

Endocrine therapy

- Not specified

Radiotherapy

- Not specified

Surgery

- Not specified

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Kenneth G. Lucas, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Milton S. Hershey Medical Center

Authority:

United States: Federal Government

Study ID:

CDR0000404366

NCT ID:

NCT00101309

Start Date:

November 2004

Completion Date:

Related Keywords:

  • Neuroblastoma
  • Sarcoma
  • recurrent neuroblastoma
  • recurrent Ewing sarcoma/peripheral primitive neuroectodermal tumor
  • Neuroblastoma
  • Sarcoma, Ewing's
  • Neuroectodermal Tumors, Primitive, Peripheral
  • Sarcoma

Name

Location

Penn State Cancer Institute at Milton S. Hershey Medical CenterHershey, Pennsylvania  17033-0850