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

Primary Purpose

Neuroblastoma, Sarcoma

Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
aldesleukin
autologous EBV-transformed B lymphoblastoid-tumor fusion cell vaccine
therapeutic autologous lymphocytes
Sponsored by
Milton S. Hershey Medical Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neuroblastoma focused on measuring recurrent neuroblastoma, recurrent Ewing sarcoma/peripheral primitive neuroectodermal tumor

Eligibility Criteria

1 Year - 30 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Penn State Cancer Institute at Milton S. Hershey Medical Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
January 7, 2005
Last Updated
December 17, 2013
Sponsor
Milton S. Hershey Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00101309
Brief Title
Vaccine Therapy and Interleukin-2 in Treating Young Patients With Relapsed or Refractory Ewing's Sarcoma or Neuroblastoma
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 Type
Interventional

2. Study Status

Record Verification Date
November 2007
Overall Recruitment Status
Unknown status
Study Start Date
November 2004 (undefined)
Primary Completion Date
November 2007 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Milton S. Hershey Medical Center

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuroblastoma, Sarcoma
Keywords
recurrent neuroblastoma, recurrent Ewing sarcoma/peripheral primitive neuroectodermal tumor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
aldesleukin
Intervention Type
Biological
Intervention Name(s)
autologous EBV-transformed B lymphoblastoid-tumor fusion cell vaccine
Intervention Type
Biological
Intervention Name(s)
therapeutic autologous lymphocytes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kenneth G. Lucas, MD
Organizational Affiliation
Milton S. Hershey Medical Center
Official's Role
Study Chair
Facility Information:
Facility Name
Penn State Cancer Institute at Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033-0850
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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