Clinical trial · Interventional
Temozolomide Plus Irinotecan in Treating Patients With Recurrent Malignant Glioma
Phase I-II Trial of CPT-11 and Temozolomide (Temodar) in Patients With Recurrent Malignant Glioma
NCT00006025CI-TRIAL-00033474completedPhase 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 use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase I/II trial to study the effectiveness of temozolomide plus irinotecan in treating patients who have recurrent malignant glioma.
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 |
|---|---|---|---|
| Brain and Central Nervous System Tumors | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| irinotecan hydrochloride | Drug | Irinotecan | ALIAS |
| temozolomide | Drug | Temozolomide | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed supratentorial malignant primary glioma of one of the following subtypes: * Glioblastoma multiforme * Anaplastic astrocytoma * Anaplastic oligodendroglioma * Mixed malignant glioma * Original histology of low-grade glioma allowed if subsequent histological confirmation of malignant glioma * Measurable recurrent or residual primary disease by MRI * Lesions with clearly defined margins * Evidence of tumor recurrence or progression by MRI or CT scan * Confirmation of true progressive disease by PET or thallium scan, magnetic resonance spectroscopy, or surgical documentation after prior interstitial brachytherapy or stereotactic radiosurgery * No more than 3 relapses after prior chemotherapy/cytotoxic therapy (including polifeprosan 20 with carmustine implant) for phase I and no more than 2 relapses for phase II PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Karnofsky 60-100% Life expectancy: * Not specified Hematopoietic: * WBC at least 3,000/mm\^3 * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 * Hemoglobin at least 10 g/dL Hepatic: * Bilirubin no greater than 1.5 mg/dL * SGOT no greater than 2 times upper limit of normal Renal: * Creatinine no greater than 1.5 mg/dL Cardiovascular: * No uncontrolled hypertension, unstable angina, or symptomatic congestive heart failure * No myocardial infarction within the past 6 months * No serious uncontrolled cardiac arrhythmia Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No mental incapacitation * HIV negative * No AIDS-related disease * No significant ongoing alcoholism or substance abuse * No severe nonmalignant systemic disease * No active infection * No other severe disease that would preclude study PRIOR CONCURRENT THERAPY: Biologic therapy: * At least 1 week since prior interferon or thalidomide and recovered * No concurrent anticancer immunotherapy * No concurrent sargramostim (GM-CSF) * No concurrent prophylactic filgrastim (G-CSF) during first course of study therapy Chemotherapy: * See Disease Characteristics * Recovered from prior chemotherapy * At least 2 weeks since prior vincristine * At least 3 weeks since prior procarbazine * At least 4 weeks since prior cytotoxic chemotherapy (6 weeks for nitrosourea) * Prior radiosensitizers allowed * No prior temozolomide or irinotecan * No other concurrent anticancer chemotherapy Endocrine therapy: * At least 1 week since prior tamoxifen and recovered * No concurrent anticancer hormonal therapy * Phase II: * Non-increasing dose of corticosteroids allowed Radiotherapy: * See Disease Characteristics * At least 4 weeks since prior radiotherapy and recovered * No concurrent anticancer radiotherapy Surgery: * See Disease Characteristics * At least 1-3 weeks since prior surgical resection and recovered Other: * At least 1 week since prior noncytotoxic agents (e.g., isotretinoin) and recovered * Concurrent enzyme-inducing anti-epileptic drugs with or without steroids allowed * No concurrent valproic acid as a single agent * No concurrent medication that would preclude study (e.g., nonsteroidal immunosuppressive agents) * No other concurrent investigational drugs * No concurrent participation in other clinical study
References
Publications (1)
- RESULTLoghin ME, Prados MD, Wen P, Junck L, Lieberman F, Fine H, Fink KL, Metha M, Kuhn J, Lamborn K, Chang SM, Cloughesy T, DeAngelis LM, Robins IH, Aldape KD, Yung WK. Phase I study of temozolomide and irinotecan for recurrent malignant gliomas in patients receiving enzyme-inducing antiepileptic drugs: a north american brain tumor consortium study. Clin Cancer Res. 2007 Dec 1;13(23):7133-8. doi: 10.1158/1078-0432.CCR-07-0874. PMID 18056194