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Irinotecan Followed by Radiation Therapy and Temozolomide in Treating Children With Newly Diagnosed Brain Tumor

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00004068
Recruitment Status : Completed
First Posted : May 8, 2003
Last Update Posted : October 4, 2011
National Cancer Institute (NCI)
Information provided by:
St. Jude Children's Research Hospital

Brief Summary:

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of irinotecan followed by radiation therapy and temozolomide in treating children who have newly diagnosed brain tumor.

Condition or disease Intervention/treatment Phase
Brain and Central Nervous System Tumors Drug: irinotecan hydrochloride Drug: temozolomide Procedure: conventional surgery Radiation: radiation therapy Phase 2

Detailed Description:


  • Evaluate the efficacy of adjuvant irinotecan in children with newly diagnosed high grade gliomas, brain stem glioma, or high risk grade II astrocytomas in terms of complete and partial response rate in patients with postoperative measurable disease, and in terms of the rate of freedom from recurrence in patients with no postoperative measurable disease.
  • Determine the 3 year overall and progression free survival rates in this patient population when treated with adjuvant irinotecan followed by radiotherapy and temozolomide.
  • Assess the hematopoietic toxicity of temozolomide following local radiotherapy in this patient population.

OUTLINE: Patients receive postoperative irinotecan IV over 60 minutes daily for 5 days on weeks 1-2. Treatment repeats every 3 weeks for 2 courses. Following completion of irinotecan and if appropriate, patients may undergo a second surgical resection.

Within 2 weeks following completion of chemotherapy or within 4 weeks of following a second resection, patients receive image guided external beam radiotherapy 5 days per week for 6 weeks. Patients with residual tumor less than 3.5 cm in maximal diameter may undergo boost radiosurgery.

At 4 weeks following completion of radiotherapy, patients receive oral temozolomide for 5 days. Treatment repeats every 3 weeks for 6 courses.

Patients are followed every 3 months for 2 years, then every 4 months for 3 years.

PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study within 5 years.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 53 participants
Primary Purpose: Treatment
Official Title: Treatment of Newly Diagnosed High-Grade Gliomas in Patients Ages Greater Than or Equal to 3 and Less Than or Equal to 21 Years With a Phase II Irinotecan Window Followed by Radiation Therapy and Temozolomide
Study Start Date : March 1999
Actual Primary Completion Date : April 2003
Actual Study Completion Date : April 2003

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed newly diagnosed brain tumors

    • Grade III or IV disease:

      • Glioblastoma multiforme
      • Anaplastic astrocytoma
      • Anaplastic oligodendroglioma
      • Anaplastic pleomorphic xanthoastrocytoma
      • Anaplastic or malignant oligoastrocytoma
      • Gemistocytic astrocytoma
      • Malignant glioma
    • Grade II glial tumors in unfavorable locations (i.e., imaging evidence of gliomatosis cerebri and/or bithalamic involvement)
    • Diffuse pontine gliomas with greater than 2/3 involvement of the pon



  • 3 to 21

Performance status:

  • Not specified

Life expectancy:

  • Not specified


  • WBC greater than 2,500/mm^3
  • Platelet count greater than 100,000/mm^3
  • Hemoglobin greater than 8.0 g/dL


  • Bilirubin no greater than 2.5 mg/dL
  • SGOT/SGPT less than 5 times normal


  • Creatinine no greater than 2.0 mg/dL


  • Not pregnant
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • HIV negative


Biologic therapy:

  • Not specified


  • No prior chemotherapy

Endocrine therapy:

  • Prior corticosteroids allowed


  • No prior radiotherapy


  • No more than 28 days since prior definitive surgery for brain tumor


  • Concurrent anticonvulsants allowed

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00004068

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United States, Tennessee
Saint Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105-2794
Sponsors and Collaborators
St. Jude Children's Research Hospital
National Cancer Institute (NCI)
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Study Chair: Amar Gajjar, MD St. Jude Children's Research Hospital

Additional Information:
Publications of Results:
Layout table for additonal information Identifier: NCT00004068     History of Changes
Other Study ID Numbers: CDR0000067271
P30CA021765 ( U.S. NIH Grant/Contract )
First Posted: May 8, 2003    Key Record Dates
Last Update Posted: October 4, 2011
Last Verified: October 2011

Keywords provided by St. Jude Children's Research Hospital:
childhood high-grade cerebral astrocytoma
childhood high-grade cerebellar astrocytoma
childhood oligodendroglioma
untreated childhood brain stem glioma
untreated childhood cerebellar astrocytoma

Additional relevant MeSH terms:
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Nervous System Neoplasms
Central Nervous System Neoplasms
Neoplasms by Site
Nervous System Diseases
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents