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Rebeccamycin Analogue in Treating Children With Solid Tumors or Non-Hodgkin's Lymphoma

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: NCT00006102
  Purpose

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

PURPOSE: Phase II trial to study the effectiveness of rebeccamycin analogue in treating children who have solid tumors or non-Hodgkin's lymphoma.


Condition Intervention Phase
Brain and Central Nervous System Tumors
Lymphoma
Neuroblastoma
Retinoblastoma
Sarcoma
Unspecified Childhood Solid Tumor, Protocol Specific
Drug: becatecarin
Phase II

Genetics Home Reference related topics:   retinoblastoma   

MedlinePlus related topics:   Cancer    Lymphoma    Neuroblastoma    Soft Tissue Sarcoma   

ChemIDplus related topics:   BMS 181176   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Open Label
Official Title:   A Phase II Trial of Rebeccamycin Analogue (NSC #655649) in Children With Solid Tumors

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

Study Start Date:   July 2000

Detailed Description:

OBJECTIVES:

  • Determine the response in children with solid tumors or non-Hodgkin's lymphoma treated with rebeccamycin analogue.
  • Determine and maintain a plasma concentration of at least 5 µg/mL of this drug in these patients.
  • Determine the toxicity of this drug in these patients.
  • Determine the pharmacokinetics of this drug in these patients.

OUTLINE: This is a multicenter study. Patients with solid tumors are stratified according to tumor histology (neuroblastoma vs Ewing's sarcoma [closed to accrual as of 5/19/03]/peripheral primative neuroectodermal tumor [PNET] vs osteosarcoma [closed to accrual as of 5/19/03] vs rhabdomyosarcoma vs non-Hodgkin's lymphoma vs other solid tumors). Patients with CNS tumors are stratified according to tumor histology (medulloblastoma/PNET vs ependymoma vs brainstem glioma vs other CNS tumors).

Patients receive rebeccamycin analogue IV over 1 hour on day 1. Treatment continues every 21 days for a total of 16 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed monthly for 1 year, every 2 months for 2 years, every 6 months for 1 year, and then annually thereafter.

PROJECTED ACCRUAL: A total of 100-200 patients will be accrued for this study within 2.4 months to 2.5 years.

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

Criteria

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed solid tumors

    • Neuroblastoma
    • Ewing's sarcoma/peripheral primitive neuroectodermal tumor (PNET)(Ewing's sarcoma closed to accrual as of 5/19/03)
    • Osteosarcoma (closed to accrual as of 5/19/03)
    • Rhabdomyosarcoma
    • Other extracranial solid tumors
    • CNS/brain tumors:

      • Medulloblastoma/PNET
      • Ependymoma
      • Brainstem glioma
      • Other CNS tumors
    • Histological verification may be waived for brainstem glioma and classic optic glioma, but biopsy recommended OR
  • Histologically or cytologically proven non-Hodgkin's lymphoma

    • Refractory to standard treatment and no curative therapy available
  • Measurable disease

PATIENT CHARACTERISTICS:

Age:

  • 21 and under at time of original diagnosis

Performance status:

  • Karnofsky 50-100% in patients over 10 years of age
  • Lansky 50-100% in patients age 10 and under

Life expectancy:

  • At least 8 weeks

Hematopoietic:

  • Absolute neutrophil count greater than 1,000/mm^3
  • Platelet count greater than 75,000/mm^3
  • Hemoglobin greater than 8.0 g/dL

Hepatic:

  • Bilirubin normal for age
  • SGPT less than 2.5 times upper limit of normal
  • Amylase normal
  • Lipase normal

Renal:

  • Creatinine normal for age OR
  • Glomerular filtration rate at least 60 mL/min

Other:

  • No concurrent uncontrolled infection
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 6 months after study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Recovered from prior immunotherapy

Chemotherapy:

  • At least 6 weeks since prior nitrosourea and recovered
  • Recovered from any other prior chemotherapy
  • No more than two prior chemotherapy regimens

Endocrine therapy:

  • CNS tumor patients receiving dexamethasone must be on stable or decreasing dose at least 2 weeks prior to study entry

Radiotherapy:

  • At least 6 weeks since prior extended radiotherapy and recovered
  • No prior total body irradiation

Surgery:

  • Prior radiosurgery allowed

Other:

  • No concurrent use of the following foods or medications:

    • Grapefruit juice
    • Erythromycin
    • Azithromycin
    • Clarithromycin
    • Rifampin and analogues
    • Fluconazole
    • Ketoconazole
    • Itraconazole
    • Cimetidine
    • Cannabinoids (marijuana or dronabinol)
    • Leukotriene inhibitors (e.g., zafirlukast and zileuton)
  • No other concurrent anticancer or investigational agents
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006102

Show 226 study locations  Show 226 Study Locations

Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)

Investigators
Study Chair:     Anne-Marie Langevin, MD     University of Texas    
  More Information

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

Publications of Results:

Study ID Numbers:   CDR0000068111, COG-P9963
First Received:   August 3, 2000
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00006102
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
childhood infratentorial ependymoma  
recurrent childhood rhabdomyosarcoma  
childhood supratentorial ependymoma  
childhood craniopharyngioma  
disseminated neuroblastoma  
recurrent neuroblastoma  
intraocular retinoblastoma  
extraocular retinoblastoma  
stage III childhood lymphoblastic lymphoma  
stage IV childhood lymphoblastic lymphoma  
recurrent childhood lymphoblastic lymphoma  
childhood central nervous system germ cell tumor  
unspecified childhood solid tumor, protocol specific  
childhood high-grade cerebral astrocytoma  
childhood oligodendroglioma  
childhood choroid plexus tumor
childhood grade I meningioma
childhood grade II meningioma
childhood grade III meningioma
stage III childhood large cell lymphoma
stage IV childhood small noncleaved cell lymphoma
stage IV childhood large cell lymphoma
recurrent childhood small noncleaved cell lymphoma
recurrent childhood large cell lymphoma
recurrent childhood brain stem glioma
recurrent childhood supratentorial primitive neuroectodermal tumor
recurrent childhood cerebellar astrocytoma
recurrent childhood cerebral astrocytoma
recurrent childhood medulloblastoma
recurrent childhood visual pathway and hypothalamic glioma

Study placed in the following topic categories:
Retinal Neoplasms
Choroid Plexus Neoplasms
Neuroectodermal Tumors, Primitive
Malignant mesenchymal tumor
Lymphoma, small cleaved-cell, diffuse
Central Nervous System Neoplasms
Retinoblastoma
Small non-cleaved cell lymphoma
Soft tissue sarcomas
Neuroblastoma
Ependymoma
Lymphoma, large-cell
Neoplasms, Germ Cell and Embryonal
Craniopharyngioma
Neuroepithelioma
Meningioma
Glioma
Choroid Plexus neoplasms
Lymphoma
Retinal Diseases
Nervous System Neoplasms
Rhabdomyosarcoma
Lymphoma, Large B-Cell, Diffuse
Immunoproliferative Disorders
Eye Neoplasms
Astrocytoma
Eye Diseases
Lymphoblastic lymphoma
Recurrence
Neuroectodermal Tumors

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Immune System Diseases
Neoplasms, Nerve Tissue
Nervous System Diseases
Neoplasms, Neuroepithelial

ClinicalTrials.gov processed this record on September 05, 2008




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