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Irinotecan in Treating Children With Refractory Solid Tumors

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ClinicalTrials.gov Identifier: NCT00004078
Recruitment Status : Completed
First Posted : January 28, 2003
Last Update Posted : June 14, 2013
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group

Tracking Information
First Submitted Date  ICMJE December 10, 1999
First Posted Date  ICMJE January 28, 2003
Last Update Posted Date June 14, 2013
Study Start Date  ICMJE October 1999
Actual Primary Completion Date October 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 13, 2013)
Objective response (PR or CR), recorded according to standard solid tumor response criteria [ Time Frame: Up to 8 years ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 13, 2013)
  • Toxicity, graded using the NCI CTCAE version 2.0 [ Time Frame: Up to 8 years ]
  • Pharmacokinetics of irinotecan hydrochloride [ Time Frame: Day 1 of course 1 ]
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 Irinotecan in Treating Children With Refractory Solid Tumors
Official Title  ICMJE Phase II Trial of Irinotecan in Children With Refractory Solid Tumors
Brief Summary This phase II trial is studying irinotecan to see how well it works in treating children with refractory solid tumors. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
Detailed Description

OBJECTIVES:

I. Determine the efficacy of irinotecan in children with refractory CNS or solid tumors.

II. Assess the toxicity, pharmacokinetics, and pharmacodynamics of this regimen in this patient population.

III. Determine patient UGT1A1 genotype and correlate genotype with toxicity and pharmacokinetic parameters of this regimen in these patients.

OUTLINE: Patients are stratified according to type of solid tumor (Ewings/PNET vs neuroblastoma vs osteosarcoma vs rhabdomyosarcoma vs other solid tumors excluding lymphomas and brain tumors) or brain tumor (medulloblastoma/PNET vs brain stem glioma vs ependymoma vs other CNS tumors).

Patients receive irinotecan IV over 60 minutes on days 1-5. Treatment repeats every 3 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 6 months for 4 years and then annually thereafter until death or until patient enters another POG study.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Childhood Central Nervous System Germ Cell Tumor
  • Childhood Choroid Plexus Tumor
  • Childhood Craniopharyngioma
  • Childhood Grade I Meningioma
  • Childhood Grade II Meningioma
  • Childhood Grade III Meningioma
  • Childhood Infratentorial Ependymoma
  • Childhood Oligodendroglioma
  • Childhood Supratentorial Ependymoma
  • Previously Treated Childhood Rhabdomyosarcoma
  • Recurrent Childhood Cerebellar Astrocytoma
  • Recurrent Childhood Cerebral Astrocytoma
  • Recurrent Childhood Ependymoma
  • Recurrent Childhood Medulloblastoma
  • Recurrent Childhood Rhabdomyosarcoma
  • Recurrent Childhood Visual Pathway and Hypothalamic Glioma
  • Recurrent Childhood Visual Pathway Glioma
  • Recurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor
  • Recurrent Neuroblastoma
  • Recurrent Osteosarcoma
  • Unspecified Childhood Solid Tumor, Protocol Specific
Intervention  ICMJE Drug: irinotecan hydrochloride
Given IV
Other Names:
  • Campto
  • Camptosar
  • CPT-11
  • irinotecan
  • U-101440E
Study Arms  ICMJE Experimental: Treatment (irinotecan hydrochloride)
Patients receive irinotecan IV over 60 minutes on days 1-5. Treatment repeats every 3 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 6 months for 4 years and then annually thereafter until death or until patient enters another POG study.
Intervention: Drug: irinotecan hydrochloride
Publications * Not Provided

*   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: June 13, 2013)
181
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date October 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histologically or cytologically confirmed CNS or solid tumors recurrent or refractory to standard therapy

    • Solid tumors:

      • Neuroblastoma
      • Ewing's Sarcoma/peripheral primitive neuroectodermal tumor (PNET)
      • Osteosarcoma
      • Rhabdomyosarcoma
      • Other extracranial solid tumors
    • CNS tumors:

      • Medulloblastoma/PNET
      • Ependymoma
      • Brain stem glioma
      • Other CNS tumor
      • Intrinsic brain stem tumor (biopsy required only if previously treated with radiosurgery)
      • Classic optic glioma (histologic requirement waived)
  • Measurable disease by imaging studies

    • No lesions assessable only by radionuclide scan
  • Previously irradiated lesions used to evaluate tumor response must show evidence of an interim increase in size
  • Performance status - Karnofsky 50-100% if more than 10 years old
  • Performance status - Lansky 50-100% if 10 years or younger
  • At least 8 weeks
  • Absolute neutrophil count greater than 1,000/mm^3
  • Platelet count greater than 100,000/mm^3
  • Hemoglobin greater than 8 mg/dL
  • Inadequate peripheral blood counts due to bone marrow infiltration allowed
  • Bilirubin no greater than 1.5 mg/dL
  • SGPT less than 5 times normal
  • Creatinine normal
  • Glomerular filtration rate at least 70 mL/min
  • No severe uncontrolled infection
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 6 months after study
  • At least 3 weeks since prior immunotherapy and recovered
  • No concurrent biologic therapy
  • At least 3 weeks since prior chemotherapy (8 weeks since prior nitrosoureas) and recovered
  • No more than 2 prior chemotherapy regimens
  • No other concurrent chemotherapy
  • Prior topotecan allowed
  • No prior irinotecan
  • Concurrent dexamethasone for brain tumor patients allowed if on a stable or decreasing dose for at least 2 weeks prior to study
  • At least 3 weeks since prior endocrine therapy
  • No other concurrent endocrine therapy
  • See Disease Characteristics
  • At least 8 weeks since prior extended radiotherapy (including evaluable lesions) and recovered
  • No prior total body radiotherapy
  • No concurrent radiotherapy
  • See Disease Characteristics
  • At least 3 weeks since prior investigational agents
  • No other concurrent investigational agents
  • No concurrent anticonvulsants
  • No concurrent medications that would interfere with the P-450 enzyme system function (e.g., erythromycin, cimetidine, fluconazole)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 1 Year 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 United States
Removed Location Countries Australia,   Canada,   Netherlands,   New Zealand,   Puerto Rico,   Switzerland
 
Administrative Information
NCT Number  ICMJE NCT00004078
Other Study ID Numbers  ICMJE P9761
NCI-2012-02310 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000067288 ( Other Identifier: Clinical Trials.gov )
POG-9761 ( Other Identifier: Pediatric Oncology Group )
CCG-P9761 ( Other Identifier: Children's Cancer Group )
COG-P9761 ( Other Identifier: Children's Oncology Group )
U10CA098543 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Children's Oncology Group
Study Sponsor  ICMJE Children's Oncology Group
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Lisa Bomgaars Children's Oncology Group
PRS Account Children's Oncology Group
Verification Date June 2013

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