Status:
UNKNOWN
Vaccine Therapy and Interleukin-2 in Treating Young Patients With Relapsed or Refractory Ewing's Sarcoma or Neuroblastoma
Lead Sponsor:
Milton S. Hershey Medical Center
Conditions:
Neuroblastoma
Sarcoma
Eligibility:
All Genders
1-30 years
Phase:
PHASE1
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 ...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
November 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00101309
Start Date
November 1 2004
Last Update
December 18 2013
Active Locations (1)
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1
Penn State Cancer Institute at Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033-0850