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Therapeutic Areas: Oncology | Pediatrics/Neonatology | Neurology
Disease Category: Neuroblastoma

Trial Information

Isotretinoin With or Without Monoclonal Antibody, Interleukin-2, and Sargramostim Following Stem Cell Transplantation in Treating Patients With Neuroblastoma

RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Interleukin-2 and sargramostim may stimulate a person's white blood cells to kill cancer cells. It is not yet known if chemotherapy is more effective with or without monoclonal antibody therapy, interleukin-2, and sargramostim following stem cell transplantation in treating neuroblastoma.

PURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy with or without monoclonal antibody, interleukin-2, and sargramostim following stem cell transplantation in treating patients who have neuroblastoma.

DISEASE CHARACTERISTICS:

• Diagnosis of neuroblastoma
• Categorized as high risk at diagnosis
• Meets all of the following criteria:
  • Patients much have completed therapy including intensive induction followed by autologous stem cell transplantation (ASCT) and radiotherapy
  • Completed frontline therapies, examples of such therapy includes:
    • Following treatment per COG-A3973 protocol
    • Following treatment per POG-9340-42
    • Following treatment per CCG-3891
    • Following treatment on NANT-2001-02
    • Enrollment on or following treatment per COG-ANBL02P1 protocol
    • Enrollment on or following treatment per ANBL07P1
    • Tandem transplant patients are eligible
• Following enrollment and treatment on or per COG-ANBL0532
• Following treatment per POG-9640 protocol
• Following treatment per COG-ANBL00P1 protocol
• Following treatment per CHP 594 or DFCI 34-DAT
• Other frontline therapy with permission from study chairs
• Patients with biopsy confirmed residual disease after ASCT are eligible
• Must meet the International Neuroblastoma Response Criteria (INRC) for CR, VGPR, or PR for primary site, soft tissue metastases, and bone metastases AND must also meet the protocol specified criteria for bone marrow response as follows:
  • No more than 10% tumor (of total nucleated cellular content) seen on any specimen from a bilateral bone marrow aspirate/biopsy
  • Patient who have no tumor seen on the prior bone marrow, and then have = 10% tumor on any of the bilateral marrow aspirate/biopsy specimens done at pre-ASCT and/or pre-enrollment evaluation will also be eligible
  • No more than 9 months from starting the first induction chemotherapy after diagnosis to the date of ASCT *
  • No progressive disease at time of registration except for protocol specified bone marrow response NOTE: * For tandem ASCT patients this is the date of the first stem cell infusion

PATIENT CHARACTERISTICS:

• Age: 30 and under at diagnosis
• Performance status: Lansky 50-100% OR
  Karnofsky 50-100%
• Life expectancy: At least 2 months
• Hematopoietic: Total absolute phagocyte count (neutrophils and monocytes) ≥ 1,000/mm^3
• Hepatic: Bilirubin ≤= 1.5 times normal
  SGPT ≤ 5 times normal
  Veno-occlusive disease (if present) stable or improving
• Renal: Creatinine adjusted according to age as follows:
  • No greater than 0.4 mg/dL (≤ 5 months)
  • No greater than 0.5 mg/dL (6 months -11 months)
  • No greater than 0.6 mg/dL (1 year-23 months)
  • No greater than 0.8 mg/dL (2 years-5 years)
  • No greater than 1.0 mg/dL (6 years-9 years)
  • No greater than 1.2 mg/dL (10 years-12 years)
  • No greater than 1.4 mg/dL (13 years and over [female])
  • No greater than 1.5 mg/dL (13 years to 15 years [male])
  • No greater than 1.7 mg/dL (16 years and over [male]) OR
  • Creatinine clearance or radioisotope glomerular filtration rate at least 70 mL/min
• Cardiovascular: Shortening fraction = 30% by echocardiogram OR
  Ejection fraction = 55% by MUGA
• Pulmonary: FEV_1 and FVC > 60% predicted by pulmonary function test OR
  No evidence of dyspnea at rest, no exercise intolerance
• Other: Not pregnant
• Fertile patients must use effective contraception
• Seizure disorder allowed if well-controlled and on anticonvulsants
• CNS toxicity < grade 2

PRIOR CONCURRENT THERAPY:
Biologic therapy:

• See Disease Characteristics
• No more than 1 prior stem cell transplantation
• No other concurrent cytokines or growth factors (e.g., filgrastim [G-CSF] or interferon)
• No IV immunoglobulin G within 2 weeks before, during, and for 1 week after monoclonal antibody Ch14.18 (arm II patients)
• No prior anti-GD2 antibody therapy
• Chemotherapy:
  • No more than 1 prior myeloablative consolidation regimen
  • No concurrent myelosuppressive chemotherapy (arm II patients)
• Endocrine therapy:
  • No concurrent corticosteroids unless for life-threatening conditions (e.g., increased intracranial pressure from CNS tumors or life-threatening allergic reactions)
• Radiotherapy:
  • See Disease Characteristics
  • At least 7 days since prior radiotherapy
• Surgery:
  • Not specified
• Other:
  • No other concurrent anticancer therapy
  • No concurrent immunosuppressive drugs (e.g., cyclosporine)
  • No concurrent pentoxifylline
  • No radiographic contrast materials during and for at least 1 week after interleukin-2 (arm II)

Patricia Green Sharpe MSN MHSA RN, Director, Department of Clinical Trials/Oncology Data Services
Memorial Health University Medical Center
William & Iffath Hoskins Center for Biomedical Research & Education
4700 Waters Avenue
Savannah, GA 31404
Phone: 912 350-7887
Fax: 912 350-8183
EMail: sharppa1@memorialhealth.com

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