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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier:
NCT00004068
First received: December 10, 1999
Last updated: October 3, 2011
Last verified: October 2011
  Purpose

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

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by St. Jude Children's Research Hospital:

Enrollment: 53
Study Start Date: March 1999
Study Completion Date: April 2003
Primary Completion Date: April 2003 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   3 Years to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004068

Locations
United States, Tennessee
Saint Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105-2794
Sponsors and Collaborators
St. Jude Children's Research Hospital
Investigators
Study Chair: Amar Gajjar, MD St. Jude Children's Research Hospital
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00004068     History of Changes
Other Study ID Numbers: CDR0000067271, P30CA021765, SJCRH: SJHG98, SPRI-P-00112, NCI-G99-1577
Study First Received: December 10, 1999
Last Updated: October 3, 2011
Health Authority: United States: Federal Government

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:
Nervous System Neoplasms
Central Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Nervous System Diseases
Irinotecan
Temozolomide
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Alkylating
Alkylating Agents

ClinicalTrials.gov processed this record on September 16, 2014