Trial Search Results

N2001-03: CEP-701 in Treating Young Patients With Recurrent or Refractory High-Risk Neuroblastoma

RATIONALE: CEP-701 may stop the growth of tumor cells by blocking the enzymes necessary for their growth.

PURPOSE: This phase I trial is studying the side effects and best dose of CEP-701 in treating young patients with recurrent or refractory high-risk neuroblastoma.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

New Approaches to Neuroblastoma Therapy Consortium

Collaborator: National Cancer Institute (NCI)


  • Drug: lestaurtinib


Phase 1



   - Diagnosis of neuroblastoma confirmed by at least 1 of the following:

      - Histology

      - Demonstrates clumps of tumor cells in the bone marrow with elevated urinary
      catecholamine metabolites

   - Recurrent or resistant/refractory disease

   - Neuroblastoma metastatic to the bone marrow with granulocytopenia, anemia, and/or
   thrombocytopenia allowed

   - High-risk disease

   - Patients in first response after completion of a prior front-line myeloablative
   regimen OR who were medically ineligible to receive a front-line myeloablative regimen
   must meet at least 1 of the following criteria:

      - Viable neuroblastoma determined by biopsy of a persistent lesion as seen on CT
      scan, MRI, or metaiodobenzylguanidine (MIBG) scan

         - If lesion was irradiated, biopsy must be performed at least 4 weeks after
         completion of prior radiotherapy

      - Morphologic evidence of tumor in bone marrow

   - Second or greater response (without histologic confirmation) allowed

   - Meets at least 1 of the following criteria:

      - At least 1 unidimensionally measurable lesion on CT scan, MRI, or X-ray

         - At least 20 mm by conventional techniques OR at least 10 mm by spiral CT

      - MIBG scan with positive uptake at a minimum of 1 site

      - Bone marrow with tumor cells on routine morphology (not by NSE staining only) of
      bilateral aspirate and/or biopsy AND/OR at least 5 tumor cells/10^6 mononuclear
      cells in the bone marrow by immunocytologic analysis of 2 consecutive bone
      marrows performed at least 1 day but no more than 4 weeks apart



   - 21 and under at diagnosis

Performance status

   - Karnofsky 50-100% (for patients > 16 years of age)

   - Lansky 50-100% (for patients ≤ 16 years of age)

Life expectancy

   - More than 2 months


   - See Disease Characteristics

   - Absolute neutrophil count ≥ 1,000/mm^3

   - Platelet count ≥ 50,000/mm^3 (transfusion independent)

   - Hemoglobin ≥ 8.0 g/dL (red blood cell transfusions allowed)


   - ALT and AST ≤ 3.0 times upper limit of normal (ULN)

   - Total bilirubin ≤ 1.5 times ULN


   - Creatinine ≤ 1.5 times normal OR

   - Creatinine clearance or radioisotope glomerular filtration rate ≥ 60 mL/min


   - Ejection fraction ≥ 50% by echocardiogram or MUGA OR

   - Fractional shortening ≥ 28% or above lower limit of normal by echocardiogram


   - Lung function normal

   - No dyspnea at rest

   - No exercise intolerance

   - No supplemental oxygen requirement


   - Not pregnant

   - Negative pregnancy test

   - Fertile patients must use effective contraception

   - No uncontrolled infection

   - No other concurrent illness that would preclude study treatment


Biologic therapy

   - See Chemotherapy

   - At least 2 weeks since prior biologic or non-myelosuppressive therapy and recovered

   - More than 7 days since prior growth factors

   - No prior allogeneic stem cell transplantation AND no extensive chronic
   graft-versus-host disease

   - No concurrent growth factors except filgrastim (G-CSF) or sargramostim (GM-CSF)
   administered for neutropenia lasting for more than 7 days or for confirmed or clinical
   septicemia associated with neutropenia


   - At least 3 months since prior myeloablative chemotherapy with stem cell

   - At least 2 weeks since prior chemotherapy and recovered

Endocrine therapy

   - No concurrent corticosteroid therapy except replacement therapy for adrenal
   insufficiency or treatment for increased intracranial pressure


   - See Disease Characteristics

   - Recovered from prior radiotherapy

   - At least 6 weeks since prior therapeutic-dose MIBG

   - At least 6 weeks since prior craniospinal or other radiotherapy involving significant
   bone marrow (i.e., total pelvis or total abdomen)

   - At least 4 weeks since prior radiotherapy to any site biopsied

   - At least 2 weeks since prior local palliative radiotherapy (small port)


   - Not specified


   - No prior CEP-701

   - No concurrent administration of any of the following CYP3A4 inhibitors:

      - Cyclosporine

      - Clotrimazole

      - Ketoconazole

      - Erythromycin

      - Clarithromycin

      - Troleandomycin

      - HIV protease inhibitors

      - Nefazodone

      - Itraconazole

      - Voriconazole

Ages Eligible for Study

N/A - 30 Years

Genders Eligible for Study


Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Peds Hem/Onc CRAs
Not Recruiting