Vaccine Therapy and Interleukin-2 in Treating Young Patients With Relapsed or Refractory Ewing's Sarcoma or Neuroblastoma
Recruitment status was Active, not recruiting
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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 |
| Estimated Enrollment: | 10 |
| Study Start Date: | November 2004 |
| Estimated Primary Completion Date: | November 2007 (Final data collection date for primary outcome measure) |
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 |
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| 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 |
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: | September 18, 2010 |
| 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 Neuroectodermal Tumors, Primitive, Peripheral Sarcoma 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 May 19, 2013