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Irinotecan in Treating Children With Refractory Solid Tumors
This study has been completed.

First Received on December 10, 1999.   Last Updated on December 28, 2010   History of Changes
Sponsor: Children's Oncology Group
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00004078
  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 irinotecan to see how well it works in treating children with refractory solid tumors.


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

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Phase II Trial of Irinotecan in Children With Refractory Solid Tumors

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Efficacy [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Toxicity [ Designated as safety issue: Yes ]
  • Pharmacokinetics [ Designated as safety issue: No ]
  • Pharmacodynamics [ Designated as safety issue: No ]

Estimated Enrollment: 225
Study Start Date: October 1999
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • Determine the efficacy of irinotecan in children with refractory CNS or solid tumors.
  • Assess the toxicity, pharmacokinetics, and pharmacodynamics of this regimen in this patient population.
  • 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.

PROJECTED ACCRUAL: A total of 225 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   1 Year to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age:

  • 1 to 21

Performance status:

  • Karnofsky 50-100% if more than 10 years old OR
  • Lansky 50-100% if 10 years or younger

Life expectancy:

  • At least 8 weeks

Hematopoietic:

  • 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

Hepatic:

  • Bilirubin no greater than 1.5 mg/dL
  • SGPT less than 5 times normal

Renal:

  • Creatinine normal
  • Glomerular filtration rate at least 70 mL/min

Other:

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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • At least 3 weeks since prior immunotherapy and recovered
  • No concurrent biologic therapy

Chemotherapy:

  • 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

Endocrine therapy:

  • 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

Radiotherapy:

  • See Disease Characteristics
  • At least 8 weeks since prior extended radiotherapy (including evaluable lesions) and recovered
  • No prior total body radiotherapy
  • No concurrent radiotherapy

Surgery:

  • See Disease Characteristics

Other:

  • 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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004078

  Show 136 Study Locations
Sponsors and Collaborators
Children's Oncology Group
Investigators
Study Chair: Lisa Bomgaars, MD Texas Children's Cancer Center
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00004078     History of Changes
Other Study ID Numbers: CDR0000067288, COG-P9761, POG-9761, CCG-P9761
Study First Received: December 10, 1999
Last Updated: December 28, 2010
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
childhood infratentorial ependymoma
recurrent childhood rhabdomyosarcoma
childhood supratentorial ependymoma
childhood craniopharyngioma
recurrent neuroblastoma
childhood central nervous system germ cell tumor
recurrent osteosarcoma
unspecified childhood solid tumor, protocol specific
childhood oligodendroglioma
childhood choroid plexus tumor
childhood grade I meningioma
childhood grade II meningioma
childhood grade III meningioma
recurrent childhood visual pathway glioma
recurrent childhood cerebellar astrocytoma
recurrent childhood cerebral astrocytoma
recurrent childhood medulloblastoma
recurrent childhood visual pathway and hypothalamic glioma
previously treated childhood rhabdomyosarcoma
recurrent Ewing sarcoma/peripheral primitive neuroectodermal tumor
recurrent childhood ependymoma

Additional relevant MeSH terms:
Nervous System Neoplasms
Neuroblastoma
Central Nervous System Neoplasms
Neoplasms
Sarcoma
Neoplasms by Site
Nervous System Diseases
Neuroectodermal Tumors, Primitive, Peripheral
Neuroectodermal Tumors, Primitive
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms, Connective and Soft Tissue
Irinotecan
Camptothecin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 12, 2012