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Irinotecan in Treating Children With Refractory Solid Tumors
This study has been completed.
First Received: December 10, 1999   Last Updated: July 23, 2008   History of Changes
Sponsors and Collaborators: Children's Oncology Group
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

MedlinePlus related topics: Cancer Neuroblastoma Soft Tissue Sarcoma
Drug Information available for: Irinotecan U 101440E Irinotecan hydrochloride
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment
Official Title: Phase II Trial of Irinotecan in Children With Refractory Solid Tumors

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
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:
Study ID Numbers: CDR0000067288, COG-P9761, POG-9761, CCG-P9761
Study First Received: December 10, 1999
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00004078     History of Changes
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

Study placed in the following topic categories:
Choroid Plexus Neoplasms
Neuroectodermal Tumors, Primitive
Irinotecan
Central Nervous System Neoplasms
Neuroblastoma
Ependymoma
Neoplasms, Connective and Soft Tissue
Sarcoma, Ewing's
Soft Tissue Sarcomas
Neoplasms, Germ Cell and Embryonal
Craniopharyngioma
Osteogenic Sarcoma
Neuroepithelioma
Meningioma
Glioma
Ewing's Family of Tumors
Nervous System Neoplasms
Rhabdomyosarcoma
Astrocytoma
Osteosarcoma
Rhabdomyosarcoma, Childhood
Ewing's Sarcoma
Camptothecin
Recurrence
Neuroectodermal Tumors
Malignant Mesenchymal Tumor
Peripheral Neuroectodermal Tumor
Medulloblastoma
Sarcoma
Oligodendroglioma

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

ClinicalTrials.gov processed this record on May 07, 2009