Clinical trial · Interventional
Procarbazine in Treating Patients With Recurrent Brain Tumor
A Phase I/II Study of Oral Procarbazine in the Treatment of Recurrent High Grade Astrocytomas
NCT00004004CI-TRIAL-00010917completedPhase 1 / Phase 2ClinicalTrials.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/II trial to study the effectiveness of procarbazine in treating patients who have progressive or recurrent astrocytoma, oligodendroglioma, or glioblastoma multiforme following treatment with radiation therapy.
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 |
|---|---|---|---|
| procarbazine hydrochloride | Drug | Procarbazine | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically proven malignant glioma of one of the following types: * Anaplastic astrocytoma * Anaplastic oligodendroglioma * Glioblastoma multiforme * Progressive or recurrent disease after radiotherapy with or without chemotherapy * Measurable disease by serial MR or CT PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Karnofsky 60-100% Life expectancy: * Greater than 2 months Hematopoietic: * Absolute neutrophil count at least 1500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * Bilirubin no greater than 1.5 mg/dL * SGPT/SGOT no greater than 4 times upper limit of normal Renal: * Creatinine no greater than 1.7 mg/dL Other: * No serious concurrent infection * No other illness that would preclude study * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No prior malignancy within the past 5 years except curatively treated basal cell skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy: * No concurrent filgrastim (G-CSF) during the first course Chemotherapy: * See Disease Characteristics * No more than 1 prior chemotherapy regimen * At least 3 weeks since prior chemotherapy (at least 6 weeks since prior nitrosoureas) * No more than 2 prior courses of carmustine or lomustine and no greater than 460 mg/m2 or 220 mg/m2, respectively * No prior procarbazine Endocrine therapy: * Not specified Radiotherapy: * See Disease Characteristics * At least 3 months since prior radiotherapy Surgery: * Prior surgery allowed Other: * Recovered from toxicity of prior therapy * At least 10 days since prior anticonvulsants for patients in Arm II * No concurrent investigational agents * No concurrent ethanol, ephedrine, isoproterenol, epinephrine, tricyclic antidepressants, paragyliline, narcotic analgesics, antihistamines, phenothiazines, hypotensives, or barbiturates * At least 14 days since prior antidepressants (e.g., SSRI and/or MAO inhibitor) * Must avoid foods high in tyramine (i.e., dark beer, wine, yogurt, cheese, bananas)
References
Publications (1)
- RESULTHe X, Batchelor TT, Grossman S, Supko JG; New Approaches to Brain Tumor Therapy (NABTT) CNS Consortium. Determination of procarbazine in human plasma by liquid chromatography with electrospray ionization mass spectrometry. J Chromatogr B Analyt Technol Biomed Life Sci. 2004 Jan 25;799(2):281-91. doi: 10.1016/j.jchromb.2003.10.061. PMID 14670747