NCT00004078

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
181

participants targeted

Target at P75+ for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 1999

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 10, 1999

Completed
3.1 years until next milestone

First Posted

Study publicly available on registry

January 28, 2003

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed
Last Updated

June 14, 2013

Status Verified

June 1, 2013

Enrollment Period

8 years

First QC Date

December 10, 1999

Last Update Submit

June 13, 2013

Conditions

Childhood Central Nervous System Germ Cell TumorChildhood Choroid Plexus TumorChildhood CraniopharyngiomaChildhood Grade I MeningiomaChildhood Grade II MeningiomaChildhood Grade III MeningiomaChildhood Infratentorial EpendymomaChildhood OligodendrogliomaChildhood Supratentorial EpendymomaPreviously Treated Childhood RhabdomyosarcomaRecurrent Childhood Cerebellar AstrocytomaRecurrent Childhood Cerebral AstrocytomaRecurrent Childhood EpendymomaRecurrent Childhood MedulloblastomaRecurrent Childhood RhabdomyosarcomaRecurrent Childhood Visual Pathway and Hypothalamic GliomaRecurrent Childhood Visual Pathway GliomaRecurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal TumorRecurrent NeuroblastomaRecurrent OsteosarcomaUnspecified Childhood Solid Tumor, Protocol Specific

Outcome Measures

Primary Outcomes (1)

  • Objective response (PR or CR), recorded according to standard solid tumor response criteria

    Up to 8 years

Secondary Outcomes (2)

  • Toxicity, graded using the NCI CTCAE version 2.0

    Up to 8 years

  • Pharmacokinetics of irinotecan hydrochloride

    Day 1 of course 1

Study Arms (1)

Treatment (irinotecan hydrochloride)

EXPERIMENTAL

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

Interventions

irinotecan hydrochlorideDRUG

Given IV

Also known as: Campto, Camptosar, CPT-11, irinotecan, U-101440E
Treatment (irinotecan hydrochloride)

Eligibility Criteria

Age1 Year - 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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
  • +36 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Oncology Group

Arcadia, California, 91006-3776, United States

Location

MeSH Terms

Conditions

Choroid Plexus NeoplasmsOligodendrogliomaAstrocytomaFamilial ependymomaMedulloblastomaOptic Nerve GliomaNeuroectodermal Tumors, Primitive, PeripheralNeuroblastomaOsteosarcoma

Interventions

Irinotecan

Condition Hierarchy (Ancestors)

Cerebral Ventricle NeoplasmsBrain NeoplasmsCentral Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesGliomaNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueNeuroectodermal Tumors, PrimitiveOptic Nerve NeoplasmsCranial Nerve NeoplasmsPeripheral Nervous System NeoplasmsCranial Nerve DiseasesOptic Nerve DiseasesEye DiseasesNeoplasms, Bone TissueNeoplasms, Connective TissueNeoplasms, Connective and Soft TissueSarcoma

Intervention Hierarchy (Ancestors)

CamptothecinAlkaloidsHeterocyclic Compounds

Study Officials

  • Lisa Bomgaars

    Children's Oncology Group

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 10, 1999

First Posted

January 28, 2003

Study Start

October 1, 1999

Primary Completion

October 1, 2007

Last Updated

June 14, 2013

Record last verified: 2013-06

Locations

US(1)