Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
No phase specified	Treatment	Closed	under 18		SJCRH-NB-1 SJCRH-NB-74

Objectives

I.  Evaluate a new schedule of drugs for the treatment of neuroblastoma.
II.  Evaluate in patients with bone marrow involvement the cell cycle kinetics 
of neuroblastoma cells.
III.  Evaluate cellular and humoral immune responses of patients with 
neuroblastoma to allogenic and autologous tumor cells.
IV.  Use adjuvant immunotherapy as additional therapy for patients with Stage 
III disease.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Patients with neuroblastoma or 
ganglioneuroblastoma who have had no prior treatment with chemotherapy.

Expected Enrollment

40 to 60 patients will be entered over 4 years.  Protocol closed 05/76.

Outline

Randomized study - in part.
Arm I:  Surgery:  Enter all patients:  Stage I and IIA - complete resection; 
Stage IIB - subtotal resection; Stages IIIA, B and C -subtotal resection when 
possible, plus second-look surgery to remove residual primary following 
complete response to chemotherapy.
Arm II:  Radiotherapy:  Enter all Stage II patients.  Enter Stage III patients 
if immediate control of tumors is required.  Chemotherapy:  Stage IIB and all 
Stage III patients before or concurrent with Radiotherapy.
Arm III:  2-Drug Combination Chemotherapy.  Cyclophosphamide, CTX, NSC-26271; 
Adriamycin, ADR, NSC-123127.  Randomize responders to Arm IV or Arm V.
Arm IV:  2-Drug Combination Chemotherapy.  CTX, ADR, continued for 8 months.
Arm V:  Immunotherapy.  Autologous tumor cells and BCG-Glaxo.

Trial Contact Information

Trial Lead Organizations

St. Jude Children's Research Hospital

Joseph Simone, MD, Protocol chair(Contact information may not be current)		Ph: 801-585-0303; 877-585-0303