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

NCT ID: NCT00101309

Last Updated: 2013-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-11-30

Brief Summary

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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

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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.

Conditions

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Neuroblastoma Sarcoma

Keywords

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recurrent neuroblastoma recurrent Ewing sarcoma/peripheral primitive neuroectodermal tumor

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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aldesleukin

Intervention Type BIOLOGICAL

autologous EBV-transformed B lymphoblastoid-tumor fusion cell vaccine

Intervention Type BIOLOGICAL

therapeutic autologous lymphocytes

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* 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
Minimum Eligible Age

1 Year

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Milton S. Hershey Medical Center

OTHER

Sponsor Role lead

Principal Investigators

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Kenneth G. Lucas, MD

Role: STUDY_CHAIR

Milton S. Hershey Medical Center

Locations

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Penn State Cancer Institute at Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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PSCI-18990

Identifier Type: -

Identifier Source: secondary_id

CDR0000404366

Identifier Type: -

Identifier Source: org_study_id