Irinotecan in Treating Children With Refractory Solid Tumors

Part of paid clinical trials in Arcadia, California.

Sponsor
Children's Oncology Group
Study ID
NCT00004078
Phase
PHASE2
Status
Completed

Conditions

  • 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 Glioma
  • Recurrent Childhood Visual Pathway and Hypothalamic Glioma
  • Recurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor
  • Recurrent Neuroblastoma
  • Recurrent Osteosarcoma
  • Unspecified Childhood Solid Tumor, Protocol Specific

Eligibility Criteria

Sex
ALL
Age
1 Year - 21 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Oct 31, 1999
Status verified
Jun 2013
Primary completion
Oct 31, 2007

Study Design

Enrollment
181 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Objective response (PR or CR), recorded according to standard solid tumor response criteria [ Time Frame: Up to 8 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
Children's Oncology GroupArcadiaCalifornia91006-3776-

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By research site
Children's Oncology Group· Arcadia, CA

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