Clinical trial · Interventional
Karenitecin in Treating Patients With Recurrent Malignant Glioma
Phase I Evaluation Of The Safety Of Karenitecin In The Treatment Of Recurrent Malignant Gliomas
NCT00014521CI-TRIAL-00001618completedPhase 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. PURPOSE: Phase I trial to study the effectiveness of karenitecin 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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| karenitecin | Drug | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed anaplastic astrocytoma, anaplastic oligodendroglioma, or glioblastoma multiforme * Progressive or recurrent disease previously treated with radiotherapy with or without chemotherapy * Prior low-grade disease that progressed to high-grade after therapy allowed * Measurable disease by MRI or CT scan PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Karnofsky 60-100% Life expectancy: * Not specified Hematopoietic: * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm3 * Hemoglobin at least 8.5 g/dL Hepatic: * Bilirubin no greater than 1.5 mg/dL * Transaminases no greater than 4 times upper limit of normal Renal: * Creatinine no greater than 1.7 mg/dL Other: * No other malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix or breast * No serious concurrent infection * No other medical illness that would preclude study * Negative pregnancy test * Not pregnant or nursing * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * See Disease Characteristics * At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered * No more than 1 prior chemotherapy regimen Endocrine therapy: * Must be on stable dose of steroids for at least 5 days Radiotherapy: * See Disease Characteristics * At least 3 months since prior radiotherapy and recovered * No more than 1 prior course of radiotherapy Surgery: * Not specified Other: * No other concurrent investigational agents * At least 10 days since prior anticonvulsant drugs that induce hepatic metabolic enzymes
References
Publications (0)
Data not yet available
No reference posted for this study.