Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Fenretinide in Treating Children With Recurrent or Resistant Neuroblastoma
This study has been completed.
Sponsors and Collaborators: Children's Oncology Group
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00053326
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: This phase II trial is studying how well fenretinide works in treating children with recurrent or resistant neuroblastoma.


Condition Intervention Phase
Neuroblastoma
Drug: fenretinide
Phase II

MedlinePlus related topics: Cancer Neuroblastoma
Drug Information available for: Fenretinide
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: A Phase II Study Of Fenretinide (NSC # 374551, IND #40294) In Children With Recurrent/Resistant High Risk Neuroblastoma

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: May 2003
Detailed Description:

OBJECTIVES:

  • Determine the response rate in pediatric patients with recurrent or resistant high-risk neuroblastoma treated with fenretinide.
  • Determine the toxic effects of this drug in these patients.
  • Determine the proportion of patients with disease detected only by bone marrow immunocytology, who clear all evidence of disease during treatment with this drug.
  • Determine minimal residual disease response by marrow and meta-iodobenzylguanidine (MIBG) I 123 scan in patients treated with this drug.

OUTLINE: Patients are stratified according to presence of measurable disease on CT scan/MRI (yes vs no). A third stratum of patients with tumor cells in bone marrow by immunocytology only is enrolled but is not evaluated for response.

Patients receive oral fenretinide 3 times daily (or 2 times daily if over 18 years of age) on days 1-7. Treatment repeats every 3 weeks for up to 30 courses in the absence of disease progression or unacceptable toxicity. Patients in stratum III who fail to acheive a complete response after 8 courses of therapy are removed from study.

Patients are followed monthly until blood counts and visual acuity are stable or normalized and then every 6 months for 2 years and annually for 3 years.

PROJECTED ACCRUAL: A total of 70 patients (25 each for strata I and II, 20 for stratum III) will be accrued for this study within 1-2 years.

  Eligibility

Ages Eligible for Study:   up to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of recurrent or resistant/refractory high-risk neuroblastoma by one or both of the following:

    • Histological confirmation
    • Demonstration of tumor cells in bone marrow with increased urinary catecholamines
  • Stratum I:

    • At least 1 unidimensionally measurable lesion*

      • At least 20 mm by MRI and/or CT scan OR at least 10 mm by spiral CT scan NOTE: *Previously irradiated lesions are not considered target lesions unless there is clear progression at the site after radiotherapy or a biopsy performed at least 4 weeks after completion of radiotherapy shows a viable neuroblastoma
  • Stratum II: Meets one or both of the following criteria:

    • At least 1 site with positive uptake on meta-iodobenzylguanidine (MIBG) I 123 scan
    • Tumor in bilateral bone marrow aspirate/biopsy by routine morphology (no NSE staining only)
  • Stratum III:

    • At least 5 tumor cells/10^6 mononuclear cells in the bone marrow by immunocytology only (on 2 successive bone marrows performed from 1 day to 4 weeks apart)
  • Patients in first response (i.e., patients with persistent tumor at end of frontline therapy, but who have never had disease relapse or progression) must have histological* or morphological (by bone marrow) confirmation** of viable tumor on CT scan, MRI, or MIBG scan after completion of myeloablative therapy (for strata I and II) NOTE: *Histological confirmation waived for patients with a prior relapse (for strata I and II)

NOTE: **If lesion was irradiated, biopsy must be performed at least 4 weeks after completion of radiotherapy (for strata I and II)

  • No catecholamine elevation only

PATIENT CHARACTERISTICS:

Age

  • 21 and under at original diagnosis

Performance status

  • 0-2

Life expectancy

  • At least 2 months

Hematopoietic

  • Hemoglobin greater than 7.5 g/dL (transfusion allowed)

Hepatic

  • Bilirubin no greater than 1.5 times normal
  • SGPT and SGOT less than 2.5 times normal

Renal

  • Creatinine normal for age
  • No hematuria or proteinuria greater than 1+ on urinalysis
  • Calcium less than 11.6 mg/dL

Other

  • Triglycerides less than 300 mg/dL
  • Not pregnant
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No seizure disorders unless on anticonvulsants and well controlled
  • No skin toxicity greater than grade 1
  • Must be able to consume entire intact study capsule in the dosage prescribed for body surface area

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Recovered from prior immunotherapy
  • At least 7 days since prior anticancer biologic therapy
  • At least 2 days since prior growth factors
  • Prior autologous stem cell transplantation allowed
  • No prior allogeneic stem cell transplantation
  • No concurrent immunomodulating agents

Chemotherapy

  • At least 2 weeks since prior myelosuppressive chemotherapy (4 weeks for nitrosoureas) and recovered
  • No concurrent anticancer chemotherapy

Endocrine therapy

  • No concurrent steroids

Radiotherapy

  • See Disease Characteristics
  • Recovered from prior radiotherapy
  • At least 4 weeks since prior radiotherapy to target lesion
  • Prior radiotherapy to nontarget lesions allowed
  • No concurrent radiotherapy to sole measurable lesion for symptom relief
  • Concurrent palliative radiotherapy to nontarget or localized painful lesions allowed

Surgery

  • Not specified

Other

  • Prior tretinoin or isotretinoin allowed
  • At least 2 weeks since other prior retinoids
  • No prior fenretinide
  • No concurrent supplemental oral or IV vitamin A, ascorbic acid, or vitamin E (except if contained in routine total parenteral nutrition [TPN] vitamin supplements)
  • No concurrent drugs suspected of causing pseudotumor cerebri (e.g., tetracycline, nalidixic acid, nitrofurantoin, phenytoin, sulfonamides, lithium, amiodarone, or vitamin A [except as part of routine TPN supplements])
  • No other concurrent anticancer agents
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00053326

  Show 236 Study Locations
Sponsors and Collaborators
Children's Oncology Group
Investigators
Study Chair: Judith G. Villablanca, MD Children's Hospital Los Angeles
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000269408, COG-ANBL0321, COG-ADVL0024, COG-A0996
Study First Received: January 27, 2003
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00053326  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent neuroblastoma

Study placed in the following topic categories:
Neuroectodermal Tumors
Neuroectodermal Tumors, Primitive
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma
Fenretinide
Neuroectodermal Tumors, Primitive, Peripheral
Recurrence
Neuroblastoma
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Anticarcinogenic Agents
Neoplasms
Neoplasms by Histologic Type
Antineoplastic Agents
Therapeutic Uses
Physiological Effects of Drugs
Neoplasms, Nerve Tissue
Neoplasms, Neuroepithelial
Protective Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009