Clinical trial · Interventional
Temozolomide Plus Lomustine Followed by Radiation Therapy in Treating Patients With High-Grade Malignant Glioma
A Phase I Study of Temozolomide and CCNU in Pediatric Patients With Newly Diagnosed Incompletely Resected Non-Brainstem High-Grade Gliomas
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Tumor | Brain Neoplasm | ALIAS | 0.90 |
| Central Nervous System Tumor | Central Nervous System Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| lomustine | Drug | Lomustine | ALIAS |
| temozolomide | Drug | Temozolomide | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Pre and Post radiation Chemotherapy
- interventionNames
- Drug: lomustine
- Drug: temozolomide
Primary outcomes (1)
- measure
- Progression Free Survival
- timeFrame
- Length of study
- description
- This trial is a phase I evaluation of temozolomide in combination with a fixed dose of CCNU with the starting dose for temozolomide
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 3 Years
- Maximum age
- 21 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * 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 PATIENT CHARACTERISTICS: Age: * 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 Hematopoietic: * 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) Hepatic: * 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 Renal: * 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 Pulmonary: * No dyspnea at rest * No exercise intolerance * Pulse oximetry at least 94% Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No uncontrolled infection PRIOR CONCURRENT THERAPY: Biologic therapy: * No prior biologic therapy * No concurrent prophylactic hematopoietic growth factors Chemotherapy: * No prior chemotherapy Endocrine therapy: * Prior corticosteroid therapy allowed * No concurrent corticosteroids as antiemetic Radiotherapy: * No prior radiotherapy Surgery: * No more than 31 days since prior maximal neurosurgical procedure Other: * No concurrent phenobarbital or cimetidine
References
Publications (1)
- RESULTJakacki RI, Yates A, Blaney SM, Zhou T, Timmerman R, Ingle AM, Flom L, Prados MD, Adamson PC, Pollack IF. A phase I trial of temozolomide and lomustine in newly diagnosed high-grade gliomas of childhood. Neuro Oncol. 2008 Aug;10(4):569-76. doi: 10.1215/15228517-2008-019. Epub 2008 May 22. PMID 18497327