Vaccine Therapy and Interleukin-2 in Treating Young Patients With Relapsed or Refractory Ewing's Sarcoma or Neuroblastoma
|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
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|
- 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|
|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|
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|
|Study Chair:||Kenneth G. Lucas, MD||Milton S. Hershey Medical Center|