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Efficacy and Tolerability of Cisplatin Plus Alternating Weekly Temozolomide in Recurrent High-grade Gliomas

Primary Purpose

High-grade Gliomas

Status

Completed

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

CDDP

Temozolomide

About this trial

This is an interventional treatment trial for High-grade Gliomas focused on measuring recurrent high-grade gliomas, cisplatin (CDDP), temozolomide (TMZ)

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Huashan Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CDDP plus Temozolomide

Arm 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) 150 2100 125 1750 100 1400 75 1050

Outcomes

Primary Outcome Measures

progression free survival (PFS)

Secondary Outcome Measures

overall survival(OS)

Full Information

NCT ID

NCT02263105

First Posted

September 28, 2014

Last Updated

July 14, 2018

Sponsor

Huashan Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02263105

Brief Title

Efficacy and Tolerability of Cisplatin Plus Alternating Weekly Temozolomide in Recurrent High-grade Gliomas

Official Title

Efficacy and Tolerability of Cisplatin Plus Alternating Weekly Temozolomide in Recurrent High-grade Gliomas: A Single-arm Prospective Phase II Clinical Study

Study Type

Interventional

2. Study Status

Record Verification Date

July 2018

Overall Recruitment Status

Completed

Study Start Date

October 2014 (Actual)

Primary Completion Date

May 2018 (Actual)

Study Completion Date

June 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Huashan Hospital

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

High-grade Gliomas

Keywords

recurrent high-grade gliomas, cisplatin (CDDP), temozolomide (TMZ)

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

67 (Actual)

8. Arms, Groups, and Interventions

Arm Title

CDDP plus Temozolomide

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

CDDP

Intervention Type

Drug

Intervention Name(s)

Temozolomide

Intervention Description

If hematologic and nonhematologic toxicity assessed according to the Common Terminology Criteria for Adverse Events (CTCAE; version 4.0) from the previous cycle had been grade 0 or 1, then TMZ dose escalation to was allowed to the maximum of 150 mg/m2. If grade 4 hematologic toxicity or grade 3 nonhematologic toxicity had occurred, then TMZ dose was reduced in 25 mg/m2 steps. If grade 4 nonhematologic toxicity occurred, patient treatment was halted. If grade 4 hematologic toxicity or grade 3 nonhematologic toxicity continued when TMZ dose was in the minimum of 75 mg/m2, patient treatment was halted.

Primary Outcome Measure Information:

Title

progression free survival (PFS)

Time Frame

at 6 months

Secondary Outcome Measure Information:

Title

overall survival(OS)

Time Frame

at 1 year and 2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Zhiyong Qin, MD

Organizational Affiliation

Huashan Hospital

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Ying Mao, MD

Organizational Affiliation

Huashan Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Yu Yao, MD

Organizational Affiliation

Huashan Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

ZhenYu Zhang

Organizational Affiliation

Huashan Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Huashan Hospital

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200040

Country

China

12. IPD Sharing Statement

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Efficacy and Tolerability of Cisplatin Plus Alternating Weekly Temozolomide in Recurrent High-grade Gliomas

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