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

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ClinicalTrials.gov Identifier: NCT00101309
Recruitment Status : Unknown
Verified November 2007 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : January 10, 2005
Last Update Posted : December 18, 2013
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Neuroblastoma Sarcoma Biological: aldesleukin Biological: autologous EBV-transformed B lymphoblastoid-tumor fusion cell vaccine Biological: therapeutic autologous lymphocytes Phase 1

Detailed Description:


  • 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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Primary Purpose: Treatment
Official Title: A Phase I Pilot Study of Tumor Cell - B Lymphoblastoid Cell Line Vaccination in Pediatric Subjects With Relapsed Ewing's Sarcoma and Neuroblastoma
Study Start Date : November 2004
Estimated Primary Completion Date : November 2007

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Diagnosis of Ewing's sarcoma OR neuroblastoma

    • Relapsed or refractory disease
  • Epstein-Barr virus positive



  • 1 to 30

Performance status

  • Lansky 70-100% OR
  • ECOG 0-2

Life expectancy

  • At least 8 weeks


  • 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


  • Creatinine clearance > 50 mL/min


  • HIV 1 and 2 negative
  • HTLV 1 and 2 negative


  • Not pregnant
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No other moribund condition


Biologic therapy

  • At least 3 months since prior autologous stem cell transplantation


  • Not specified

Endocrine therapy

  • Not specified


  • Not specified


  • Not specified

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00101309

United States, Pennsylvania
Penn State Cancer Institute at Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033-0850
Sponsors and Collaborators
Milton S. Hershey Medical Center
Study Chair: Kenneth G. Lucas, MD Milton S. Hershey Medical Center

ClinicalTrials.gov Identifier: NCT00101309     History of Changes
Other Study ID Numbers: CDR0000404366
First Posted: January 10, 2005    Key Record Dates
Last Update Posted: December 18, 2013
Last Verified: November 2007

Keywords provided by National Cancer Institute (NCI):
recurrent neuroblastoma
recurrent Ewing sarcoma/peripheral primitive neuroectodermal tumor

Additional relevant MeSH terms:
Sarcoma, Ewing
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neuroectodermal Tumors, Primitive, Peripheral
Neuroectodermal Tumors, Primitive
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents