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| Sponsored by: |
Milton S. Hershey Medical Center |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00101309 |
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 |
Drug: aldesleukin Drug: autologous EBV-transformed B lymphoblastoid-tumor fusion cell vaccine Drug: therapeutic autologous lymphocytes |
Phase I |
| Study Type: | Interventional |
| Study Design: | 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 |
| Primary Completion Date: | November 2007 (Final data collection date for primary outcome measure) |
OBJECTIVES:
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.
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
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hepatic
AST and ALT < 2.5 times normal (in the absence of liver metastases)
Renal
Immunologic
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
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
| Study ID Numbers: | CDR0000404366, PSCI-18990 |
| Study First Received: | January 7, 2005 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00101309 |
| Health Authority: | United States: Federal Government |
|
recurrent neuroblastoma recurrent Ewing sarcoma/peripheral primitive neuroectodermal tumor |
|
Neuroectodermal Tumors, Primitive Ewing's family of tumors Malignant mesenchymal tumor Osteosarcoma Osteogenic sarcoma Neuroblastoma Recurrence Soft tissue sarcomas Neuroectodermal Tumors Neoplasms, Connective and Soft Tissue |
Ewing's sarcoma Sarcoma, Ewing's Aldesleukin Interleukin-2 Peripheral neuroectodermal tumor Neoplasms, Germ Cell and Embryonal Sarcoma Neuroepithelioma Neuroectodermal Tumors, Primitive, Peripheral Neoplasms, Glandular and Epithelial |
|
Anti-Infective Agents Neoplasms by Histologic Type Anti-HIV Agents Antineoplastic Agents Neoplasms, Nerve Tissue Antiviral Agents Pharmacologic Actions |
Neoplasms Neoplasms, Bone Tissue Anti-Retroviral Agents Therapeutic Uses Neoplasms, Connective Tissue Neoplasms, Neuroepithelial |
