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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase I	Treatment	Closed	21 and under	NCI	POG-9343

Objectives

I.  Evaluate the safety and maximum tolerated dose of interleukin-6 given with 
granulocyte-macrophage colony stimulating factor (IL-6/GM-CSF) in patients 
with advanced neuroblastoma following autologous bone marrow transplantation 
on protocol POG-9340-42.

II.  Assess hematopoietic reconstitution with post-transplant IL-6/GM-CSF in 
anticipation of a randomized study of these agents in the same clinical 
setting.

III.  Assess the pharmacokinetics of IL-6 in children.

Entry Criteria

Disease Characteristics:

Histologically confirmed Stage D neuroblastoma eligible for
autologous bone marrow transplantation on protocol POG-9340-42
  At least 1 course of CAV (cyclophosphamide, doxorubicin,
  vincristine) and radiotherapy to the primary tumor completed
  on POG-9341

  Registration and bone marrow harvest completed on POG-9342

No brain metastases

Prior/Concurrent Therapy:

See Disease Characteristics

Patient Characteristics:

Age:
  21 and under

Performance status:
  ECOG 0 or 1

Life expectancy:
  At least 12 weeks

Hematopoietic:
  Not specified

Hepatic:
  Bilirubin no greater than 1.5 mg/dl
  SGPT less than 2 x normal

Renal:
  Creatinine less than 2 x normal for age
  No glomerulonephritis

Cardiovascular:
  Ejection fraction at least LLN
  No arrhythmia requiring therapy
  No thrombotic vascular disease

Pulmonary:
  No moderate to severe pulmonary compromise

Other:
  No severe uncontrolled infection
  No history of autoimmune disorder
  No HIV infection
  No requirement for steroids
  No pregnant women

Expected Enrollment

At least 6 patients will be entered at each dose studied.

Outline

Hematopoietic Rescue.  Granulocyte-Macrophage Colony Stimulating Factor 
(Immunex), GM-CSF, NSC-613795; Interleukin-6 (Sandoz), IL-6, NSC-643497.

Trial Contact Information

Trial Lead Organizations

Pediatric Oncology Group

Roger Berkow, MD, Protocol chair		Ph: 205-939-9285 Email: rberkow@peds.uab.edu