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

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ClinicalTrials.gov Identifier: NCT00004068
Recruitment Status : Completed
First Posted : May 8, 2003
Last Update Posted : October 4, 2011
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
St. Jude Children's Research Hospital

Tracking Information
First Submitted Date  ICMJE December 10, 1999
First Posted Date  ICMJE May 8, 2003
Last Update Posted Date October 4, 2011
Study Start Date  ICMJE March 1999
Actual Primary Completion Date April 2003   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00004068 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Irinotecan Followed by Radiation Therapy and Temozolomide in Treating Children With Newly Diagnosed Brain Tumor
Official Title  ICMJE 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
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.

Detailed Description

OBJECTIVES:

  • 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Primary Purpose: Treatment
Condition  ICMJE Brain and Central Nervous System Tumors
Intervention  ICMJE
  • Drug: irinotecan hydrochloride
  • Drug: temozolomide
  • Procedure: conventional surgery
  • Radiation: radiation therapy
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October¬†3,¬†2011)
53
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE April 2003
Actual Primary Completion Date April 2003   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age:

  • 3 to 21

Performance status:

  • Not specified

Life expectancy:

  • Not specified

Hematopoietic:

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

Hepatic:

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

Renal:

  • Creatinine no greater than 2.0 mg/dL

Other:

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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • No prior chemotherapy

Endocrine therapy:

  • Prior corticosteroids allowed

Radiotherapy:

  • No prior radiotherapy

Surgery:

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

Other:

  • Concurrent anticonvulsants allowed
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 3 Years to 21 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00004068
Other Study ID Numbers  ICMJE CDR0000067271
P30CA021765 ( U.S. NIH Grant/Contract )
SJCRH: SJHG98
SPRI-P-00112
NCI-G99-1577
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE St. Jude Children's Research Hospital
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Study Chair: Amar Gajjar, MD St. Jude Children's Research Hospital
PRS Account St. Jude Children's Research Hospital
Verification Date October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP