NCT00004068

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Mar 1999

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 1999

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

December 10, 1999

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2003

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 8, 2003

Completed
Last Updated

October 4, 2011

Status Verified

October 1, 2011

Enrollment Period

4.1 years

First QC Date

December 10, 1999

Last Update Submit

October 3, 2011

Conditions

Brain and Central Nervous System Tumors

Keywords

childhood high-grade cerebral astrocytomachildhood high-grade cerebellar astrocytomachildhood oligodendrogliomauntreated childhood brain stem gliomauntreated childhood cerebellar astrocytoma

Interventions

irinotecan hydrochlorideDRUG
temozolomideDRUG
conventional surgeryPROCEDURE
radiation therapyRADIATION

Eligibility Criteria

Age3 Years - 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Saint Jude Children's Research Hospital

Memphis, Tennessee, 38105-2794, United States

Location

Related Publications (3)

  • Broniscer A, Chintagumpala M, Fouladi M, Krasin MJ, Kocak M, Bowers DC, Iacono LC, Merchant TE, Stewart CF, Houghton PJ, Kun LE, Ledet D, Gajjar A. Temozolomide after radiotherapy for newly diagnosed high-grade glioma and unfavorable low-grade glioma in children. J Neurooncol. 2006 Feb;76(3):313-9. doi: 10.1007/s11060-005-7409-5.

    PMID: 16200343RESULT

  • Broniscer A, Iacono L, Chintagumpala M, Fouladi M, Wallace D, Bowers DC, Stewart C, Krasin MJ, Gajjar A. Role of temozolomide after radiotherapy for newly diagnosed diffuse brainstem glioma in children: results of a multiinstitutional study (SJHG-98). Cancer. 2005 Jan 1;103(1):133-9. doi: 10.1002/cncr.20741.

    PMID: 15565574RESULT

  • Broniscer A, Chintagumpala M, Bowers D, et al.: Upfront protracted irinotecan (CPT-11) followed by radiotherapy (RT) and temozolomide (TMZ) in the treatment of children with newly diagnosed high-grade glioma (HGG) and unfavorable low-grade glioma (LGG): results of a multi-institutional study (SJHG-98). [Abstract] Neuro-Oncology 6 (4): TP-01, 385, 2004.

    RESULT

Related Links

MeSH Terms

Conditions

Central Nervous System NeoplasmsAstrocytomaOligodendroglioma

Interventions

IrinotecanTemozolomideRadiotherapy

Condition Hierarchy (Ancestors)

Nervous System NeoplasmsNeoplasms by SiteNeoplasmsNervous System DiseasesGliomaNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

CamptothecinAlkaloidsHeterocyclic CompoundsDacarbazineTriazenesOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingTherapeutics

Study Officials

  • Amar Gajjar, MD

    St. Jude Children's Research Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 10, 1999

First Posted

May 8, 2003

Study Start

March 1, 1999

Primary Completion

April 1, 2003

Study Completion

April 1, 2003

Last Updated

October 4, 2011

Record last verified: 2011-10

Locations

US(1)