Clinical trial · Interventional
Efficacy and Tolerability of Cisplatin Plus Alternating Weekly Temozolomide in Recurrent High-grade Gliomas
Efficacy and Tolerability of Cisplatin Plus Alternating Weekly Temozolomide in Recurrent High-grade Gliomas: A Single-arm Prospective Phase II Clinical Study
- 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)
Currently, the prognosis of recurrent high-grade gliomas is still dismal with no standard treatment protocol established. Cisplatin (CDDP), recommended by National Comprehensive Cancer Network (NCCN) as a chemotherapeutic agent in salvage treatment for recurrent high-grade gliomas, was shown to reduce O6-alkylguanine DNA-alkyl transferase (AGAT) activity and potentially capable of enhancing the antitumor effects of temozolomide (TMZ). Compared to the standard 5-day TMZ regimen, alternating weekly regimen that deliver more prolonged exposure of TMZ may lead to higher cumulative doses, and may deplete more O6-methylguanine DNA methyltransferase (MGMT), thus reducing the resistance of tumor cells to TMZ. The investigators therefore initiate a single-arm Phase II study to evaluate the efficacy and tolerability of CDDP plus alternating weekly TMZ regimen in patients with recurrent high-grade gliomas.
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 |
|---|---|---|---|
| High-grade Gliomas | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CDDP | Drug | Cisplatin | ALIAS |
| Temozolomide | Drug | Temozolomide | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- CDDP plus Temozolomide
- description
- Patients were treated with CDDP and TMZ. CDDP was administered iv from Day 1 to 3 with everyday dose of 30mg. TMZ was orally administered from Day 1 to 7 and Day 15 to 21, with everyday dose of 125mg/m2 (Level 2). The period of one chemotherapy cycle is 28 days. TMZ dose levels were listed in Table 1. Table 1 TMZ dose levels Dose levels Daily TMZ dose( mg/m2/d ) TMZ dose per cycle(mg/m2) 1. 150 2100 2. 125 1750 3. 100 1400 4. 75 1050
- interventionNames
- Drug: CDDP
- Drug: Temozolomide
Primary outcomes (1)
- measure
- progression free survival (PFS)
- timeFrame
- at 6 months
Secondary outcomes (1)
- measure
- overall survival(OS)
- timeFrame
- at 1 year and 2 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Histological diagnosis of primary tumor as high-grade gliomas (WHO III or IV) * All patients should complete radiation therapy for primary gliomas. * MRI showed unequivocal evidence of tumor recurrence or progression. * The time to be enrolled should be more than 90 days after the radiation therapy. * Written informed consent * Eastern Cooperative Oncology Group(ECOG) score: 0-2 * The patients with recurrent gliomas were treated without dose-dense TMZ therapy before enrollment. * Surgical interventions for recurrent gliomas are permitted and patients with no residual tumor are permitted Exclusion Criteria: * Abnormal function of liver or renal (value more than 1.5 fold normal upper limit) * Blood routing: Hb \< 90g/L, absolute neutrophil count≤1.5\*10\^9/L, platelet \< 100\*10\^9/L * Pregnant or lactating women * Allergic to administered drugs * Radiation therapy in the previous 90 days before enrollment * The patients with recurrent gliomas were treated with dose-dense TMZ therapy before enrollment. * Acute infection in need of antibiotics intravenously * Participation in other clinical trials in the 90 days before enrollment
References
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