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

NCT00101309 | Unknown Phase 1

• 2 other identifiers: CDR0000404366PSCI-18990
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Neuroblastoma; Sarcoma

Keywords

recurrent neuroblastoma; recurrent Ewing sarcoma/peripheral primitive neuroectodermal tumor

Interventions

aldesleukin BIOLOGICAL

autologous EBV-transformed B lymphoblastoid-tumor fusion cell vaccine BIOLOGICAL

therapeutic autologous lymphocytes BIOLOGICAL

Eligibility Criteria

• Age: 1 Year - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead

Study Sites (1)

Penn State Cancer Institute at Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033-0850, United States

Location

MeSH Terms

Conditions

Neuroblastoma; Sarcoma; Neuroectodermal Tumors, Primitive, Peripheral

Interventions

aldesleukin

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors, Primitive; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Neoplasms, Connective and Soft Tissue

Study Officials

• Kenneth G. Lucas, MD

  Milton S. Hershey Medical Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 7, 2005
• First Posted: January 10, 2005
• Study Start: November 1, 2004
• Primary Completion: November 1, 2007
• Last Updated: December 18, 2013

Record last verified: 2007-11

Locations

US (1)