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Status:

COMPLETED

N2004-03: Intravenous Fenretinide in Treating Young Patients With Recurrent or Resistant Neuroblastoma

Lead Sponsor:

Nant Operations Center

Collaborating Sponsors:

National Cancer Institute (NCI)

Conditions:

Neuroblastoma

Eligibility:

All Genders

Up to 30 years

Phase:

PHASE1

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as fenretinide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. PURPOSE: This phas...

Detailed Description

OBJECTIVES: Primary * To determine the maximum tolerated dose of fenretinide when given as a continuous intravenous infusion in young patients with recurrent and/or resistant neuroblastoma. * To def...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • Diagnosis of neuroblastoma either by histological confirmation and/or demonstration of tumor cells in the bone marrow with increased urinary catecholamines
  • Differentiating ganglioneuroblastoma allowed
  • No histological evidence only of ganglioneuroma by tumor biopsy or bone marrow biopsy
  • High-risk disease meeting at least one of the following criteria:
  • Recurrent/progressive disease at any time
  • Refractory disease (i.e., less than a partial response to front-line therapy that included ≥ 4 courses of chemotherapy)
  • Persistent disease after at least a partial response to front-line therapy (i.e., still has residual disease by MIBG, CT/MRI, or bone marrow biopsy)
  • Biopsy of at least one residual site demonstrating viable neuroblastoma required (tumor by bone marrow morphology is considered adequate documentation of disease)
  • Measurable disease meeting at least one of the following criteria:
  • Measurable tumor on MRI or CT scan, defined as at least one unidimensionally measurable lesion ≥ 20 mm by conventional techniques or ≥ 10 mm by spiral CT scan
  • For patients with persistent disease, a biopsy\* of bone marrow or bone or soft tissue site must have demonstrated viable neuroblastoma
  • MIBG scan with positive uptake at a minimum of one site
  • For patients with persistent disease, a biopsy\* of a MIBG positive site must have demonstrated viable neuroblastoma
  • Bone marrow with tumor cells seen on routine morphology (not by NSE staining only) of bilateral aspirate and/or biopsy of one bone marrow sample NOTE: \*If the lesion was irradiated, the biopsy must have been done at least 4 weeks after completion of radiotherapy
  • No CNS parenchymal or meningeal-based lesions
  • Skull-based tumor lesions with or without intracranial extension are allowed provided there are no neurologic signs or symptoms or hydrocephalus related to the lesion
  • Patients with a history of complete surgical resection of CNS lesions are eligible provided there is no evidence of CNS lesions by MRI or CT scan at study entry
  • Patients with a history of CNS lesions must be off corticosteroid therapy for CNS lesions for ≥ 4 weeks
  • PATIENT CHARACTERISTICS:
  • Performance status 0-2
  • Life expectancy ≥ 2 months
  • ANC ≥ 500/mm³
  • Platelet count ≥ 50,000/mm³ (transfusion independent)
  • Hemoglobin ≥ 8.0 g/dL (transfusion independent)
  • Serum creatinine ≤ 1.5 times normal for age
  • Total bilirubin ≤ 1.5 times normal for age
  • ALT and AST ≤ 3 times normal for age
  • Serum triglycerides \< 300 mg/dL
  • Serum calcium \< 11.6 mg/dL
  • Lipase normal for age
  • PT/PTT ≤ 1.5 times upper limit of normal for age (without fresh frozen plasma support; vitamin K allowed)
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception prior to, during, and for 2 months after completion of study treatment
  • LVEF ≥ 55% by ECHO or MUGA scan OR fractional shortening ≥ 27% by ECHO
  • No EKG abnormality
  • No dyspnea at rest or requirement for oxygen
  • No hematuria and/or proteinuria \> 1+ on urinalysis
  • No known history of allergy to egg products
  • No known history of allergy to soy bean oil
  • No skin toxicity \> grade 1 per CTCAE v3
  • Seizure disorder allowed if seizures are controlled on anticonvulsants and the anticonvulsant(s) is not contraindicated
  • Known genetic, metabolic, or psychiatric conditions, or other ongoing serious medical issues must be approved by the study chair prior to study registration
  • PRIOR CONCURRENT THERAPY:
  • Recovered from all prior chemotherapy, immunotherapy, or radiotherapy
  • More than 3 weeks since prior myelosuppressive chemotherapy (4 weeks for nitrosoureas) and/or biologic therapy without stem cell support
  • More than 7 days since prior hematopoietic growth factors
  • No prior radiotherapy to the only site of measurable disease unless there has been subsequent disease progression at that site or a biopsy of that site showed viable neuroblastoma ≥ 4 weeks after completion of radiotherapy
  • Prior CNS irradiation allowed
  • At least 2 weeks since prior small field (focal) radiotherapy
  • At least 6 weeks since prior large field radiotherapy (i.e., total-body irradiation, craniospinal radiotherapy, whole abdominal or total lung radiotherapy, or radiotherapy to \> 50% of marrow space)
  • At least 56 days since prior myeloablative autologous stem cell transplantation
  • At least 4 weeks since prior myelosuppressive therapy with stem cell support
  • At least 6 weeks since prior MIBG therapy
  • Prior oral fenretinide therapy allowed
  • At least 3 weeks since prior retinoid therapies
  • No prior organ transplantation
  • No prior myeloablative allogeneic stem cell transplantation unless stem cells were from an identical twin sibling
  • No concurrent systemic corticosteroids, including corticosteroids for emesis control
  • Concurrent inhaled corticosteroids for asthma control or steroids for metabolic deficiency states allowed
  • Concurrent palliative radiotherapy allowed provided the irradiated sites will not be used to measure response
  • No concurrent parenteral intralipids
  • No other concurrent chemotherapy or immunomodulating agents
  • No concurrent drugs suspected of causing pseudotumor cerebri, including tetracycline, nalidixic acid, nitrofurantoin, phenytoin, sulfonamides, lithium, or amiodarone
  • No concurrent vitamin A, C, or E supplements (except as part of routine total parenteral nutrition \[TPN\] supplements or as part of a single daily standard dose of oral multivitamin supplement)
  • No concurrent medications that may potentially act as modulators of intracellular ceramide levels or ceramide cytotoxicity, sphingolipid transport, or p-glycoprotein (MDR1) or MDR1 drug/lipid transporters, including cyclosporine or analogue, verapamil, tamoxifen or analogue, ketoconazole, chlorpromazine, mifepristone (RU486), indomethacin, or sulfinpyrazone
  • No other concurrent anticancer agents
  • No concurrent herbal supplements or other alternative therapy medications
  • No concurrent anti-arrhythmia or inotropic cardiac medications

Exclusion

    Key Trial Info

    Start Date :

    December 1 2006

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    March 1 2012

    Estimated Enrollment :

    17 Patients enrolled

    Trial Details

    Trial ID

    NCT00646230

    Start Date

    December 1 2006

    End Date

    March 1 2012

    Last Update

    April 7 2023

    Active Locations (13)

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

    Page 1 of 4 (13 locations)

    1

    Childrens 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 Helen Diller Family Comprehensive Cancer Center

    San Francisco, California, United States, 94115

    4

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

    Atlanta, Georgia, United States, 30322