NCT00100802

Brief Summary

This phase II trial is studying how well giving radiation therapy together with temozolomide and lomustine works in treating young patients with newly diagnosed gliomas. Radiation therapy uses high energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as temozolomide and lomustine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy together with temozolomide and lomustine after surgery may kill any remaining tumor cells.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
118

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Mar 2005

Longer than P75 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

First Submitted

Initial submission to the registry

January 6, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 7, 2005

Completed
2 months until next milestone

Study Start

First participant enrolled

March 21, 2005

Completed
7.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
4.4 years until next milestone

Results Posted

Study results publicly available

January 13, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2017

Completed
Last Updated

February 15, 2023

Status Verified

January 1, 2023

Enrollment Period

7.5 years

First QC Date

January 6, 2005

Results QC Date

November 18, 2016

Last Update Submit

January 18, 2023

Conditions

Anaplastic AstrocytomaCentral Nervous System NeoplasmGlioblastomaGliosarcomaSpinal Cord Neoplasm

Outcome Measures

Primary Outcomes (2)

  • One Year Overall Survival

    Estimated one year survival using the Kaplan-Meier methodology.

    One year

  • Occurrence of Death Attributable to Complications of Protocol Therapy

    Number of deaths due to complications of protocol therapy.

    While receiving protocol therapy (up to 301 days excluding delays) or within 30 days of Termination of Protocol Therapy

Study Arms (1)

Treatment (lomustine, temozolomide, radiation therapy)

EXPERIMENTAL

Patients receive oral temozolomide once daily on days 1-42. Patients also undergo concurrent radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33 and 36-40. Patients who did not undergo prior gross total resection also undergo boost radiotherapy once daily on days 43-47. Four weeks after completion of chemoradiotherapy, patients receive oral temozolomide once daily on days 1-5 and oral lomustine on day 1. Treatment repeats every 42 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Other: Laboratory Biomarker AnalysisDrug: LomustineRadiation: Radiation TherapyDrug: Temozolomide

Interventions

Laboratory Biomarker AnalysisOTHER

Correlative studies

Treatment (lomustine, temozolomide, radiation therapy)
LomustineDRUG

Given PO

Also known as: 1-(2-Chloroethyl)-3-cyclohexyl-1-nitrosourea, 1-Nitrosourea, 1-(2-chloroethyl)-3-cyclohexyl-, Belustin, Belustine, CCNU, Cecenu, CeeNU, Chloroethylcyclohexylnitrosourea, Citostal, Gleostine, Lomeblastin, Lomustinum, Lucostin, Lucostine, N-(2-Chloroethyl)-N'-cyclohexyl-N-nitrosourea, Prava, RB-1509, WR-139017
Treatment (lomustine, temozolomide, radiation therapy)
Radiation TherapyRADIATION

Undergo radiation therapy

Also known as: Cancer Radiotherapy, ENERGY_TYPE, Irradiate, Irradiated, Irradiation, Radiation, Radiation Therapy, NOS, Radiotherapeutics, Radiotherapy, RT, Therapy, Radiation
Treatment (lomustine, temozolomide, radiation therapy)
TemozolomideDRUG

Given PO

Also known as: CCRG-81045, Imidazo[5,1-d]-1,2,3,5-tetrazine-8-carboxamide, 3, 4-dihydro-3-methyl-4-oxo-, M & B 39831, M and B 39831, Methazolastone, RP-46161, SCH 52365, Temcad, Temodal, Temodar, Temomedac, TMZ
Treatment (lomustine, temozolomide, radiation therapy)

Eligibility Criteria

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

You may qualify if:

  • Histologically confirmed, newly diagnosed high-grade glioma of 1 of the following histologies:
  • Anaplastic astrocytoma
  • Glioblastoma multiforme
  • Gliosarcoma
  • Primary spinal cord malignant gliomas allowed
  • No primary brainstem tumors
  • Has undergone surgical resection or biopsy of the tumor within the past 31 days
  • Pre-operative and post-operative brain MRI with and without gadolinium-contrast OR pre-operative and post-operative spine MRI for spinal cord primaries
  • Post-operative MRI not required for patients who undergo biopsy only
  • No evidence of neuraxis dissemination
  • Spine MRI and cerebrospinal fluid cytology required only if clinically indicated
  • Performance status - Karnofsky 50-100% (for patients \> 16 years of age)
  • Performance status - Lansky 50-100% (for patients ≤ 16 years of age)
  • At least 8 weeks
  • Absolute neutrophil count ≥ 1,000/mm\^3
  • +26 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Oncology Group

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (3)

  • Pollack IF, Hamilton RL, Burger PC, Brat DJ, Rosenblum MK, Murdoch GH, Nikiforova MN, Holmes EJ, Zhou T, Cohen KJ, Jakacki RI; Children's Oncology Group. Akt activation is a common event in pediatric malignant gliomas and a potential adverse prognostic marker: a report from the Children's Oncology Group. J Neurooncol. 2010 Sep;99(2):155-63. doi: 10.1007/s11060-010-0297-3. Epub 2010 Jul 4.

    PMID: 20607350BACKGROUND

  • Pollack IF, Hamilton RL, Sobol RW, Nikiforova MN, Nikiforov YE, Lyons-Weiler MA, LaFramboise WA, Burger PC, Brat DJ, Rosenblum MK, Gilles FH, Yates AJ, Zhou T, Cohen KJ, Finlay JL, Jakacki RI; Children's Oncology Group. Mismatch repair deficiency is an uncommon mechanism of alkylator resistance in pediatric malignant gliomas: a report from the Children's Oncology Group. Pediatr Blood Cancer. 2010 Dec 1;55(6):1066-71. doi: 10.1002/pbc.22634.

    PMID: 20589656BACKGROUND

  • Pollack IF, Hamilton RL, Sobol RW, Nikiforova MN, Lyons-Weiler MA, LaFramboise WA, Burger PC, Brat DJ, Rosenblum MK, Holmes EJ, Zhou T, Jakacki RI; Children's Oncology Group. IDH1 mutations are common in malignant gliomas arising in adolescents: a report from the Children's Oncology Group. Childs Nerv Syst. 2011 Jan;27(1):87-94. doi: 10.1007/s00381-010-1264-1. Epub 2010 Aug 20.

    PMID: 20725730RESULT

MeSH Terms

Conditions

AstrocytomaCentral Nervous System NeoplasmsGlioblastomaGliosarcomaSpinal Cord Neoplasms

Interventions

LomustineRadiotherapyRadiationTemozolomide

Condition Hierarchy (Ancestors)

GliomaNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueNervous System NeoplasmsNeoplasms by SiteNervous System DiseasesSpinal Cord DiseasesCentral Nervous System Diseases

Intervention Hierarchy (Ancestors)

Nitrosourea CompoundsUreaAmidesOrganic ChemicalsNitroso CompoundsTherapeuticsPhysical PhenomenaDacarbazineTriazenesImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Results Point of Contact

Title
Results Reporting Coordinator
Organization
Children's Oncology Group
resultsreporingcoordinator@childrensoncologygroup.org
626-447-0064

Study Officials

  • Regina I Jakacki

    Children's Oncology Group

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 6, 2005

First Posted

January 7, 2005

Study Start

March 21, 2005

Primary Completion

September 1, 2012

Study Completion

June 30, 2017

Last Updated

February 15, 2023

Results First Posted

January 13, 2017

Record last verified: 2023-01

Locations

US(1)