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NCT Number: NCT02263105

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

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.

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Key information

Conditions

High-grade Gliomas

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Huashan Hospital

Shanghai, Shanghai Municipality, 200040, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CDDP

Drug

Temozolomide

Drug

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 outcomes

  1. progression free survival (PFS)

    Time frame: at 6 months

Secondary outcomes

  1. overall survival(OS)

    Time frame: at 1 year and 2 years

Sponsors and collaborators

Lead sponsor

Huashan Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Oct 13, 2014
Registry last updated
Jul 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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