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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2007 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00101309
First received: January 7, 2005
Last updated: December 17, 2013
Last verified: November 2007
  Purpose

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

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 10
Study Start Date: November 2004
Estimated Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Detailed 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.

  Eligibility

Ages Eligible for Study:   1 Year to 30 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00101309

Locations
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
Investigators
Study Chair: Kenneth G. Lucas, MD Milton S. Hershey Medical Center
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00101309     History of Changes
Other Study ID Numbers: CDR0000404366, PSCI-18990
Study First Received: January 7, 2005
Last Updated: December 17, 2013
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Neuroblastoma
Sarcoma, Ewing's
Sarcoma
Neuroectodermal Tumors, Primitive, Peripheral
Neuroectodermal Tumors, Primitive
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Osteosarcoma
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Aldesleukin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on July 26, 2014