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Status:

COMPLETED

N2003-01: Irinotecan, Temozolomide, and Cefixime in Treating Young Patients With Recurrent or Resistant Neuroblastoma

Lead Sponsor:

Children's Hospital Los Angeles

Collaborating Sponsors:

National Cancer Institute (NCI)

Conditions:

Diarrhea

Drug/Agent Toxicity by Tissue/Organ

Eligibility:

All Genders

1-30 years

Phase:

PHASE1

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as irinotecan and temozolomide, work in different ways to stop tumor cells from dividing so they stop growing or die. Temozolomide may help irinotecan kill ...

Detailed Description

OBJECTIVES: Primary * Determine the maximum tolerated dose of oral irinotecan when administered with fixed-dose temozolomide and cefixime in pediatric patients with recurrent or resistant high-risk ...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • Histologically confirmed neuroblastoma AND/OR demonstration of tumor cells in the bone marrow with increased urinary catecholamines
  • High-risk disease meeting 1 of the following criteria:
  • Recurrent or progressive disease
  • Resistant or refractory disease (i.e., never achieved a complete response to therapy AND never had new sites of disease or progression of initial sites)
  • Measurable disease meeting at least 1 of the following criteria:
  • Unidimensionally measurable tumor ≥ 20 mm by MRI, CT scan, or x-ray OR ≥ 10 mm by spiral CT scan\*
  • At least 1 site with positive uptake by metaiodobenzylguanidine (MIBG) scan\*
  • Bone marrow with tumor cells seen on routine morphology (not by NSE staining only) of bilateral aspirate AND/OR biopsy on 1 bone marrow sample NOTE: \*Patients who never experienced disease recurrence or progression must demonstrate viable neuroblastoma in a biopsy of either bone marrow or bone and/or soft tissue site (biopsy must be performed ≥ 4 weeks after completion of prior radiotherapy if lesion was irradiated)
  • PATIENT CHARACTERISTICS:
  • Age
  • 1 to 30 at diagnosis
  • Performance status
  • ECOG 0-2
  • Life expectancy
  • At least 2 months
  • Hematopoietic
  • Absolute neutrophil count ≥ 750/mm\^3
  • Platelet count ≥ 75,000/mm\^3 (without transfusion)
  • Hemoglobin ≥ 8.0 g/dL (transfusion allowed)
  • Hepatic
  • SGPT and SGOT \< 5 times normal
  • Bilirubin ≤ 1.5 times normal
  • Renal
  • Creatinine ≤ 1.5 times normal for age
  • No greater than 0.8 mg/dL (≤ 5 years of age)
  • No greater than 1.0 mg/dL (6 to 10 years of age)
  • No greater than 1.2 mg/dL (11 to 15 years of age)
  • No greater than 1.5 mg/dL (\> 15 years of age)
  • Other
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No allergy to cephalosporins
  • No active diarrhea
  • No uncontrolled infection
  • PRIOR CONCURRENT THERAPY:
  • Biologic therapy
  • See Chemotherapy
  • Recovered from prior immunotherapy
  • More than 3 weeks since prior biologic therapy and recovered
  • More than 2 days since prior hematopoietic growth factors
  • No concurrent epoetin alfa
  • No concurrent prophylactic hematopoietic growth factors during the first treatment course
  • No concurrent immunomodulating agents except steroids to control intracranial pressure
  • Chemotherapy
  • Prior myeloablative therapy and autologous stem cell transplantation allowed
  • No prior allogeneic stem cell transplantation
  • More than 3 weeks since prior myelosuppressive chemotherapy (4 weeks for nitrosoureas) and recovered
  • Prior temozolomide, irinotecan, or topotecan allowed
  • No prior temozolomide and irinotecan as combination therapy
  • No other concurrent chemotherapy
  • Endocrine therapy
  • See Biologic therapy
  • Radiotherapy
  • At least 6 weeks since prior large field radiotherapy (e.g., total body irradiation, craniospinal therapy, whole abdomen, total lung, or \> 50% bone marrow space) and recovered
  • At least 4 weeks since prior radiotherapy to biopsied lesions (for study entry) and recovered
  • At least 6 weeks since prior MIBG therapy
  • Concurrent radiotherapy to painful lesions allowed provided the lesions are not used to assess treatment response
  • Surgery
  • Not specified
  • Other
  • No concurrent enzyme-inducing anticonvulsants (e.g., phenobarbital, phenytoin, or carbamazepine)
  • No other concurrent anticancer agents

Exclusion

    Key Trial Info

    Start Date :

    May 1 2004

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    Estimated Enrollment :

    30 Patients enrolled

    Trial Details

    Trial ID

    NCT00093353

    Start Date

    May 1 2004

    Last Update

    October 15 2010

    Active Locations (13)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 4 (13 locations)

    1

    Children's Hospital Los Angeles

    Los Angeles, California, United States, 90027-0700

    2

    Lucile Packard Children's Hospital at Stanford University Medical Center

    Palo Alto, California, United States, 94304

    3

    UCSF Comprehensive Cancer Center

    San Francisco, California, United States, 94143

    4

    AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus

    Atlanta, Georgia, United States, 30322