Efficacy and Tolerability of Cisplatin Plus Alternating Weekly Temozolomide in Recurrent High-grade Gliomas
- Registration Number
- NCT02263105
- Lead Sponsor
- Huashan Hospital
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 67
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description CDDP plus Temozolomide CDDP 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 CDDP plus Temozolomide Temozolomide 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
- Primary Outcome Measures
Name Time Method progression free survival (PFS) at 6 months
- Secondary Outcome Measures
Name Time Method overall survival(OS) at 1 year and 2 years
Trial Locations
- Locations (1)
Huashan Hospital
🇨🇳Shanghai, Shanghai, China