Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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. ;


Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms

  • Astrocytoma
  • 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
  • Choroid Plexus Neoplasms
  • Craniopharyngioma
  • Ependymoma
  • Glioma
  • Medulloblastoma
  • Meningioma
  • Neoplasms
  • Neuroblastoma
  • Neuroectodermal Tumors
  • Neuroectodermal Tumors, Primitive
  • Neuroectodermal Tumors, Primitive, Peripheral
  • Oligodendroglioma
  • Optic Nerve Glioma
  • Osteosarcoma
  • 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
  • Rhabdomyosarcoma
  • Sarcoma, Ewing
  • Unspecified Childhood Solid Tumor, Protocol Specific

NCT number NCT00004078
Study type Interventional
Source Children's Oncology Group
Contact
Status Completed
Phase Phase 2
Start date October 1999

See also
  Status Clinical Trial Phase
Terminated NCT00788125 - Dasatinib, Ifosfamide, Carboplatin, and Etoposide in Treating Young Patients With Metastatic or Recurrent Malignant Solid Tumors Phase 1/Phase 2
Completed NCT01164163 - INCB18424 in Treating Young Patients With Relapsed or Refractory Solid Tumor, Leukemia, or Myeloproliferative Disease Phase 1
Completed NCT00985868 - AT9283 in Children and Adolescents With Relapsed and Refractory Solid Tumors Phase 1
Terminated NCT00949117 - Cyproheptadine Hydrochloride and Nutritional Supplementation in Treating Young Patients With Weight Loss With Cancer Phase 2
Completed NCT00281944 - Combination Chemotherapy in Treating Young Patients With Advanced Solid Tumors Phase 1
Completed NCT00253474 - PEG-Interferon Alfa-2b in Treating Young Patients With Plexiform Neurofibroma Phase 1
Recruiting NCT00084695 - Umbilical Cord Blood for Stem Cell Transplantation in Treating Young Patients With Malignant or Nonmalignant Diseases Phase 2
Completed NCT00053963 - FR901228 in Treating Children With Refractory or Recurrent Solid Tumors or Leukemia Phase 1
Completed NCT00003070 - Enalapril in Treating Heart Damage Patients Who Received Anthracycline Chemotherapy for Childhood Cancer Phase 3
Completed NCT00004212 - DX-8951f in Treating Children With Advanced Solid Tumors or Lymphomas Phase 1
Completed NCT00016861 - Irinotecan in Treating Children With Refractory or Progressive Solid Tumors Phase 1
Completed NCT00004005 - Irinotecan Followed By Fluorouracil and Leucovorin in Treating Patients With Stage III or Stage IV Colorectal Carcinoma (Cancer), Other Refractory Carcinoma, or Metastatic Adenoma (Cancer) of Unknown Primary Origin Phase 2
Completed NCT00003754 - Thalidomide and Cyclophosphamide in Treating Children With Recurrent or Refractory Childhood Cancers Phase 2
Completed NCT00003173 - High-Dose Thiotepa Plus Peripheral Stem Cell Transplantation in Treating Patients With Refractory Solid Tumors Phase 2
Recruiting NCT00898794 - Effect of Bevacizumab and VEGF on Platelet Clustering in Patients Who Are Receiving Bevacizumab for Cancer N/A
Terminated NCT00429702 - Diphenhydramine, Lorazepam, and Dexamethasone in Treating Nausea and Vomiting Caused By Chemotherapy Phase 2
Completed NCT00387920 - Sunitinib in Treating Young Patients With Refractory Solid Tumors Phase 1
Completed NCT00459238 - Telephone-Based Cancer Education With or Without Telephone-Based Counseling in Young Participants N/A
Completed NCT00138216 - Temozolomide, Vincristine, and Irinotecan in Treating Young Patients With Refractory Solid Tumors Phase 1
Terminated NCT00176540 - Dextromethorphan in Treating Patients With Fatigue Caused by Cancer N/A