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Temozolomide Plus Lomustine Followed by Radiation Therapy in Treating Patients With High-Grade Malignant Glioma

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.
ClinicalTrials.gov Identifier: NCT00006024
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : February 13, 2014
Information provided by (Responsible Party):

Study Description
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 more than one chemotherapy drug with radiation therapy may kill more tumor cells.

PURPOSE: Phase I trial to study the effectiveness of temozolomide plus lomustine followed by radiation therapy in treating patients who have high-grade malignant glioma.

Condition or disease Intervention/treatment Phase
Brain Tumor Central Nervous System Tumor Drug: lomustine Drug: temozolomide Phase 1

Detailed Description:


  • Determine the maximum tolerated dose of temozolomide when administered with lomustine in patients with high-grade malignant gliomas.
  • Determine the dose-limiting toxic effects of this regimen in these patients.
  • Evaluate the feasibility of radiotherapy after this treatment regimen in this patient population.
  • Evaluate the radiographic responses in patients treated with this regimen.

OUTLINE: This is a multicenter, dose-escalation study of temozolomide.

Patients receive oral temozolomide on days 1-5 and oral lomustine on day 1. Treatment continues every 28 days, if blood counts have recovered, for 2 courses in the absence of disease progression or unacceptable toxicity. Patients then undergo radiotherapy on days 1-5 weekly for 6 weeks. Patients continue the same chemotherapy regimen for up to 6 more courses beginning 4 weeks after completion of radiotherapy.

Cohorts of 3-6 patients receive escalating doses of temozolomide until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

Patients are followed for survival.

PROJECTED ACCRUAL: A total of 3-30 patients will be accrued for this study.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Study of Temozolomide and CCNU in Pediatric Patients With Newly Diagnosed Incompletely Resected Non-Brainstem High-Grade Gliomas
Study Start Date : November 2000
Primary Completion Date : January 2005
Study Completion Date : September 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Pre and Post radiation Chemotherapy Drug: lomustine Drug: temozolomide

Outcome Measures

Primary Outcome Measures :
  1. Progression Free Survival [ Time Frame: Length of study ]
    This trial is a phase I evaluation of temozolomide in combination with a fixed dose of CCNU with the starting dose for temozolomide

Eligibility Criteria

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 high-grade malignant glioma of one of the following subtypes:

    • Glioblastoma
    • Anaplastic astrocytoma
    • Anaplastic oligoastrocytoma
    • Gliomatosis cerebri
  • No disseminated disease or primary spinal cord malignancies
  • Measurable intracranial residual disease by MRI



  • 3 and over
  • Under 22 at time of diagnosis

Performance status:

  • Karnofsky 50-100% if over 10 years of age
  • Lansky 50-100% if 10 years of age or under

Life expectancy:

  • At least 8 weeks


  • Absolute neutrophil count at least 1,000/mm^3
  • Platelet count at least 100,000/mm^3 (transfusion independent)
  • Hemoglobin at least 8.0 g/dL (RBC transfusions allowed)


  • Bilirubin no greater than 1.5 times normal for age
  • SGPT no greater than 2.5 times normal for age
  • Albumin at least 2 g/dL


  • Creatinine no greater than 1.5 times normal for age OR
  • Creatinine clearance or radioisotope glomerular filtration rate at least lower limit of normal for age


  • No dyspnea at rest
  • No exercise intolerance
  • Pulse oximetry at least 94%


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No uncontrolled infection


Biologic therapy:

  • No prior biologic therapy
  • No concurrent prophylactic hematopoietic growth factors


  • No prior chemotherapy

Endocrine therapy:

  • Prior corticosteroid therapy allowed
  • No concurrent corticosteroids as antiemetic


  • No prior radiotherapy


  • No more than 31 days since prior maximal neurosurgical procedure


  • No concurrent phenobarbital or cimetidine
Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT00006024

  Show 235 Study Locations
Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Study Chair: Regina Jakacki, MD Children's Hospital of Pittsburgh of UPMC
More Information

Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT00006024     History of Changes
Other Study ID Numbers: ADVL0011
COG-ADVL0011 ( Other Identifier: Children's Oncology Group )
CCG-ADVL0011 ( Other Identifier: Children's Cancer Group )
CCG-A0993 ( Other Identifier: Children's Cancer Group )
CDR0000068036 ( Other Identifier: Clinical Trials.gov )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: February 13, 2014
Last Verified: February 2014

Keywords provided by Children's Oncology Group:
childhood high-grade cerebral astrocytoma

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