Clinical trial · Interventional
Temozolomide in Treating Young Patients With Refractory or Recurrent Leukemia
A Phase I Trial Of Temozolomide In Pediatric Patients With Refractory/Recurrent Leukemias
NCT00083070CI-TRIAL-00013814completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- 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, such as temozolomide, work in different ways to stop cancer cells from dividing so they stop growing or die. PURPOSE: This phase I trial is studying the side effects and best dose of temozolomide in treating young patients with refractory or recurrent leukemia.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| temozolomide | Drug | Temozolomide | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Temozolomide Therapy
- interventionNames
- Drug: temozolomide
Primary outcomes (3)
- measure
- Maximum tolerated dose and recommended phase II dose
- measure
- Toxicity as assessed by CTCAE 3.0
- measure
- Pharmacokinetics as assessed by CI, area under the curve (AUC), and half-life (T ½)
Secondary outcomes (2)
- measure
- Antitumor activity
- measure
- Biologic activity and mechanisms of resistance
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
- Maximum age
- 21 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed leukemia of any of the following types: * Acute lymphoblastic leukemia * Acute myeloid leukemia * Chronic myelogenous leukemia in blast crisis * Refractory or recurrent disease * Immunophenotypic confirmation of disease at initial diagnosis or recurrence * More than 25% blasts in the bone marrow (M3) * Active extramedullary disease allowed except for leptomeningeal disease * No known curative therapy or therapy proven to prolong survival with an acceptable quality of life * No active CNS disease PATIENT CHARACTERISTICS: Age * 1 to 21 Performance status * Karnofsky 50-100% (for patients \> 10 years of age) * Lansky 50-100% (for patients ≤ 10 years of age) Life expectancy * Not specified Hematopoietic * WBC \< 30,000/mm\^3 (hydroxyurea or leukapheresis allowed at the discretion of the principal investigator) * Platelet count ≥ 20,000/mm\^3 (platelet transfusions allowed) * Hemoglobin ≥ 8.0 g/dL (red blood cell transfusions allowed) Hepatic * ALT ≤ 5 times upper limit of normal (ULN) * Albumin ≥ 2 g/dL * Bilirubin ≤ 1.5 times ULN Renal * Creatinine normal for age OR * Creatinine clearance OR radioisotope glomerular filtration rate ≥ 70 mL/min/1.73 m\^2 Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No uncontrolled infection PRIOR CONCURRENT THERAPY: Biologic therapy * At least 7 days since prior biologic therapy, including immunotherapy * At least 3 months since prior stem cell transplantation * No evidence of active graft-vs-host disease * No concurrent biologic therapy * No concurrent immunotherapy Chemotherapy * Recovered from prior chemotherapy * At least 6 weeks since prior nitrosoureas * Prior therapy with hydroxyurea allowed for up to 24 hours before initiation of study drug * No other concurrent chemotherapy Endocrine therapy * Concurrent hydrocortisone or other corticosteroids allowed as premedications prior to blood product transfusions in patients with prior severe allergic reactions Radiotherapy * Recovered from prior radiotherapy * No concurrent radiotherapy Surgery * Not specified Other * No other concurrent anticancer agents * No other concurrent investigational drugs
References
Publications (2)
- RESULTHorton TM, Thompson PA, Berg SL, Adamson PC, Ingle AM, Dolan ME, Delaney SM, Hedge M, Weiss HL, Wu MF, Blaney SM; Children's Oncology Group Study. Phase I pharmacokinetic and pharmacodynamic study of temozolomide in pediatric patients with refractory or recurrent leukemia: a Children's Oncology Group Study. J Clin Oncol. 2007 Nov 1;25(31):4922-8. doi: 10.1200/JCO.2007.12.0667. PMID 17971589
- RESULTHorton TM, Dolan E, Hegde M, et al.: A phase I study of temozolomide (Temodar®) in pediatric patients with relapsed or refractory leukemia: a Children's Oncology Group study. [Abstract] Blood 106 (11): A-4455, 2005.