Irinotecan in Treating Children With Refractory Solid Tumors

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT00004078
First received: December 10, 1999
Last updated: June 13, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention Phase
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
Drug: irinotecan hydrochloride
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
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 Children's Oncology Group:

Primary Outcome Measures:
  • Objective response (PR or CR), recorded according to standard solid tumor response criteria [ Time Frame: Up to 8 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Toxicity, graded using the NCI CTCAE version 2.0 [ Time Frame: Up to 8 years ] [ Designated as safety issue: Yes ]
  • Pharmacokinetics of irinotecan hydrochloride [ Time Frame: Day 1 of course 1 ] [ Designated as safety issue: No ]

Enrollment: 181
Study Start Date: October 1999
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: irinotecan hydrochloride
Given IV
Other Names:
  • Campto
  • Camptosar
  • CPT-11
  • irinotecan
  • U-101440E

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.

  Eligibility

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

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004078

Locations
United States, California
Children's Oncology Group
Arcadia, California, United States, 91006-3776
Sponsors and Collaborators
Children's Oncology Group
Investigators
Principal Investigator: Lisa Bomgaars Children's Oncology Group
  More Information

No publications provided

Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT00004078     History of Changes
Other Study ID Numbers: P9761, NCI-2012-02310, CDR0000067288, POG-9761, CCG-P9761, COG-P9761, U10CA098543
Study First Received: December 10, 1999
Last Updated: June 13, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Astrocytoma
Craniopharyngioma
Adamantinoma
Ependymoma
Glioma
Medulloblastoma
Meningioma
Neuroblastoma
Oligodendroglioma
Osteosarcoma
Rhabdomyosarcoma
Choroid Plexus Neoplasms
Neoplasms, Germ Cell and Embryonal
Neuroectodermal Tumors
Neuroectodermal Tumors, Primitive
Rhabdomyosarcoma, Embryonal
Optic Nerve Glioma
Neoplasms
Sarcoma, Ewing
Neuroectodermal Tumors, Primitive, Peripheral
Sarcoma
Neoplasms, Neuroepithelial
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Bone Neoplasms
Neoplasms by Site
Bone Diseases
Musculoskeletal Diseases
Neoplasms, Vascular Tissue

ClinicalTrials.gov processed this record on August 28, 2014