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

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ClinicalTrials.gov Identifier: NCT00006102
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : February 5, 2013
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Tracking Information
First Submitted Date  ICMJE August 3, 2000
First Posted Date  ICMJE January 27, 2003
Last Update Posted Date February 5, 2013
Study Start Date  ICMJE July 2000
Actual Primary Completion Date June 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00006102 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Rebeccamycin Analogue in Treating Children With Solid Tumors or Non-Hodgkin's Lymphoma
Official Title  ICMJE A Phase II Trial of Rebeccamycin Analogue (NSC #655649) in Children With Solid Tumors
Brief Summary Phase II trial to study the effectiveness of rebeccamycin analogue in treating children who have solid tumors or non-Hodgkin's lymphoma. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.
Detailed Description

OBJECTIVES:

I. Determine the response in children with solid tumors or non-Hodgkin's lymphoma treated with rebeccamycin analogue.

II. Determine and maintain a plasma concentration of at least 5 µg/mL of this drug in these patients.

III. Determine the toxicity of this drug in these patients. IV. 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Brain and Central Nervous System Tumors
  • Lymphoma
  • Neuroblastoma
  • Retinoblastoma
  • Sarcoma
  • Unspecified Childhood Solid Tumor, Protocol Specific
Intervention  ICMJE Drug: becatecarin
Study Arms  ICMJE Experimental: Arm I

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.

Intervention: Drug: becatecarin
Publications * Langevin AM, Bernstein M, Kuhn JG, Blaney SM, Ivy P, Sun J, Chen Z, Adamson PC; Children's Oncology Group. A phase II trial of rebeccamycin analogue (NSC #655649) in children with solid tumors: a Children's Oncology Group study. Pediatr Blood Cancer. 2008 Mar;50(3):577-80.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February¬†4,¬†2013)
200
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date June 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 21 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Canada,   Netherlands,   New Zealand,   Puerto Rico,   Switzerland,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00006102
Other Study ID Numbers  ICMJE NCI-2012-01851
COG-P9963
CDR0000068111 ( Registry Identifier: PDQ (Physician Data Query) )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party National Cancer Institute (NCI)
Study Sponsor  ICMJE National Cancer Institute (NCI)
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Anne-Marie Langevin, MD The University of Texas Health Science Center at San Antonio
PRS Account National Cancer Institute (NCI)
Verification Date November 2010

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