Clinical trial · Interventional
Oxaliplatin in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
Phase I/II Trial of Oxaliplatin as Neoadjuvant Treatment in Adults With Newly Diagnosed Glioblastoma Multiforme
NCT00005856CI-TRIAL-00009115terminatedPhase 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
Why stopped (as posted): Administratively complete.
Summary
Brief summary (as posted)
This phase I/II trial is studying the side effects and best dose of oxaliplatin in treating patients with newly diagnosed glioblastoma multiforme. Drugs used in chemotherapy, such as oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adult Giant Cell Glioblastoma | Adult Giant Cell Glioblastoma | ONTOLOGY_EXACT | 0.98 |
| Adult Glioblastoma | Adult Glioblastoma | ONTOLOGY_EXACT | 0.98 |
| Adult Gliosarcoma | Adult Gliosarcoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| oxaliplatin | Drug | Oxaliplatin | ALIAS |
| pharmacological study | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (oxaliplatin)
- description
- Patients receive oxaliplatin IV over 2 hours on day 1. Treatment repeats every 14 days for a maximum of 6 courses in the absence of unacceptable toxicity or disease progression.
- interventionNames
- Drug: oxaliplatin
- Other: pharmacological study
Primary outcomes (3)
- measure
- Maximum-tolerated dose (MTD) defined as the dose level at which 2 out of 6 or the dose level below that at which >= 2 of 3 or > 2 of 6 patients experience dose-limiting toxicity (DLT) assessed by Common Toxicity Criteria (CTC) version 2.0 (Phase I)
- timeFrame
- 14 days
- measure
- DLT is defined as grade 3 or 4 nonhematological toxicities or hematological toxicities as assessed by CTC version 2.0 (Phase I)
- timeFrame
- 14 days
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed supratentorial grade IV astrocytoma * Glioblastoma multiforme * Subtotal resection or biopsy with measurable and contrast-enhancing disease on the postoperative, pretreatment MRI/CT scan * Performance status - Karnofsky 60-100% * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 * Hemoglobin at least 9.0 g/dL * Bilirubin normal * Creatinine normal * Creatinine clearance at least 60 mL/min * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No serious concurrent infection or medical illness that would jeopardize ability to receive protocol chemotherapy with reasonable safety * No other prior malignancy within the past 5 years except curatively treated carcinoma in situ or basal cell skin cancer * No grade 2 or greater pre-existing sensory neuropathy * No history of allergy to platinum compounds or to antiemetics appropriate for administration in conjunction with protocol chemotherapy * Mini mental score at least 15 * No prior immunotherapy for glioblastoma multiforme * No prior biologic therapy for glioblastoma multiforme, including: * Immunotoxins * Immunoconjugates * Antiangiogenesis compounds * Antisense * Peptide receptor antagonists * Interferons * Interleukins * Tumor infiltrating lymphocytes * Lymphokine activated killer cells * Gene therapy * No concurrent filgrastim (G-CSF) * No prior chemotherapy for glioblastoma multiforme * No prior hormonal therapy for glioblastoma multiforme * Prior glucocorticoid therapy for glioblastoma multiforme allowed * Must be maintained on a stable (lowest required dose) corticosteroid regimen for at least 5 days before and during study * No concurrent dexamethasone as an antiemetic * No prior radiotherapy for glioblastoma multiforme * Recovered from immediate postoperative period * At least 10 days since prior anticonvulsant drug that induces hepatic metabolic enzymes * No other concurrent investigational agents
References
Publications (0)
Data not yet available
No reference posted for this study.