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Radiation Therapy, Temozolomide, and Lomustine in Treating Young Patients With Newly Diagnosed Gliomas

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 3 Years - 21 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - 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.
  • - Platelet count ≥ 100,000/mm^3 (transfusion independent) - Hemoglobin ≥ 8 g/dL (transfusions allowed) - Bilirubin ≤ 1.5 times upper limit of normal (ULN) - ALT ≤ 2.5 times ULN.
  • - Albumin ≥ 2 g/dL.
  • - Creatinine ≤ 1.5 times ULN.
  • - Creatinine clearance or radioisotope glomerular filtration rate ≥ lower limit of normal.
  • - No evidence of dyspnea at rest.
  • - No exercise intolerance.
  • - Pulse oximetry ≥ 94% (if determination is clinically indicated) - Not pregnant or nursing.
  • - Negative pregnancy test.
  • - Fertile patients must use effective contraception during and for 2 months after study participation.
  • - Able to swallow oral medication.
  • - Seizures allowed provided they are well controlled with anticonvulsants.
  • - No hypersensitivity to temozolomide.
  • - No prior biologic agents.
  • - No prior chemotherapy.
  • - Prior corticosteroids allowed.
  • - No concurrent corticosteroids as an antiemetic.
  • - Concurrent corticosteroids allowed only for treatment of increased intracranial pressure.
  • - No concurrent radiotherapy using cobalt-60.
  • - See Disease Characteristics.
  • - No other prior treatment.
  • - No concurrent phenobarbital or cimetidine.
- No concurrent co-trimoxazole for Pneumocystis carinii pneumonia prophylaxis during study chemoradiotherapy

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT00100802
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Children's Oncology Group
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Regina I Jakacki
Principal Investigator Affiliation Children's Oncology Group
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other, NIH
Overall Status Completed
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Anaplastic Astrocytoma, Central Nervous System Neoplasm, Glioblastoma, Gliosarcoma, Spinal Cord Neoplasm
Additional Details

PRIMARY OBJECTIVES:

  • I. Compare event-free survival of pediatric patients with newly diagnosed high-grade gliomas treated with adjuvant radiotherapy and temozolomide followed by temozolomide and lomustine with historical controls.
  • II. Determine the toxicity of this regimen in these patients.
  • III. Correlate MGMT and p53 expression in tumor tissue with outcome in patients treated with this regimen.
  • IV. Correlate polymorphisms in GSTP1, GSTM1 and GSTT1 genes and GSTP1 protein expression in tumors with survival in patients treated with this regimen.
OUTLINE: This is a pilot, multicenter study. CHEMORADIOTHERAPY: 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. MAINTENANCE CHEMOTHERAPY: 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. Patients are followed every 3 months for 1 year, every 6 months for 3 years and then annually thereafter.

Arms & Interventions

Arms

Experimental: Treatment (lomustine, temozolomide, radiation therapy)

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.

Interventions

Other: - Laboratory Biomarker Analysis

Correlative studies

Drug: - Lomustine

Given PO

Radiation: - Radiation Therapy

Undergo radiation therapy

Drug: - Temozolomide

Given PO

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Children's Oncology Group, Philadelphia, Pennsylvania

Status

Address

Children's Oncology Group

Philadelphia, Pennsylvania, 19104

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