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Rebeccamycin Analogue in Treating Children With Solid Tumors or Non-Hodgkin's Lymphoma
This study has been completed.
Study NCT00006102   Information provided by National Cancer Institute (NCI)
First Received: August 3, 2000   Last Updated: February 17, 2009   History of Changes

August 3, 2000
February 17, 2009
July 2000
 
 
 
Complete list of historical versions of study NCT00006102 on ClinicalTrials.gov Archive Site
 
 
 
Rebeccamycin Analogue in Treating Children With Solid Tumors or Non-Hodgkin's Lymphoma
A Phase II Trial of Rebeccamycin Analogue (NSC #655649) in Children With Solid Tumors

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.

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.

Phase II
Interventional
Treatment, Open Label
  • Brain and Central Nervous System Tumors
  • Lymphoma
  • Neuroblastoma
  • Retinoblastoma
  • Sarcoma
  • Unspecified Childhood Solid Tumor, Protocol Specific
Drug: becatecarin
 
Langevin AM, Bernstein M, Kuhn JG, Blaney SM, Ivy P, Sun J, Chen Z, Adamson PC. A phase II trial of rebeccamycin analogue (NSC #655649) in children with solid tumors: A Children's Oncology Group study. Pediatr Blood Cancer. 2007 Jul 3; [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
 
 
 

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
Both
up to 21 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Canada,   Netherlands,   New Zealand,   Puerto Rico,   Switzerland
 
NCT00006102
 
CDR0000068111, COG-P9963
Children's Oncology Group
National Cancer Institute (NCI)
Study Chair: Anne-Marie Langevin, MD University of Texas
National Cancer Institute (NCI)
September 2003

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP