NCT01765088

Brief Summary

This study is being conducted to help determine whether the addition of Interferon-alpha(α-IFN),which were determined sensitized the activity of Temozolomide(TMZ) in vivo and vitro, when given along with temozolomide during the monthly cycles that follow radiation, is able to delay tumor growth, shrink tumors, or impact how long people with newly diagnosed high-grade glioma.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Sep 2012

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 7, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 10, 2013

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

February 23, 2018

Status Verified

February 1, 2018

Enrollment Period

5.3 years

First QC Date

January 7, 2013

Last Update Submit

February 21, 2018

Conditions

Anaplastic OligoastrocytomaAnaplastic AstrocytomaGlioblastoma

Keywords

High-grade gliomachemotherapyTemozolomideInterferon-alpha

Outcome Measures

Primary Outcomes (1)

  • Over-all survival

    5-year

Secondary Outcomes (1)

  • Quality of life

    5-year

Study Arms (2)

temozolomide

ACTIVE COMPARATOR

Four weeks after radiotherapy, patients will be received 6 cycle of temozolomide (150 mg/m\^2 daily on Days 1-5 of each 28 day study cycle and 200 mg/m\^2 daily of subsequent cycles)

Drug: Temozolomide

temozolomide +α-IFN

EXPERIMENTAL

Four weeks after radiotherapy, patients will be received 6 cycle of temozolomide plus α-IFN α-IFN：3mIU (3million) Day1,3,5 of each 28 day TMZ：150 mg/m\^2 daily on Days 2-6 of each 28 day study cycle and 200 mg/m\^2 daily of subsequent cycles

Drug: TemozolomideDrug: α-IFN

Interventions

TemozolomideDRUG

dosed at 200 mg/m2 (150 mg/m2 for the first cycle) daily for 5 consecutive days, repeated every 28 days

Also known as: Temodar
temozolomidetemozolomide +α-IFN
α-IFNDRUG

3mIU (3million) D1，3，5

Also known as: INTRONA
temozolomide +α-IFN

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age: 18 years to 75 years
  • newly diagnosed WHO III-IV glioma after operation and radiotherapy
  • Karnofsky Performance Score ≥ 60
  • Adequate bone marrow, liver and renal function
  • Ability of subject to understand character and individual consequences of the clinical trial
  • Written informed consent
  • anticipating survival ≥2 months

You may not qualify if:

  • Refusal to participate the study
  • Known hypersensitivity or contraindication to temozolomide
  • Incompletely radiation
  • Pregnant or lactating females
  • Malignant tumor other than brain tumor
  • Contraindicated for MRI examination
  • Unable to comply with the follow-up studies of this trial
  • Purulent and chronic infected wounds
  • Uncontrolled psychotic disorders or epilepsy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

Related Publications (1)

  • Guo C, Yang Q, Xu P, Deng M, Jiang T, Cai L, Li J, Sai K, Xi S, Ouyang H, Liu M, Li X, Li Z, Ni X, Cao X, Li C, Wu S, Du X, Su J, Xue X, Wang Y, Li G, Qin Z, Yang H, Zhou T, Liu J, Hu X, Wang J, Jiang X, Lin F, Zhang X, Ke C, Lv X, Lv Y, Hu W, Zeng J, Chen Z, Zhong S, Wang H, Chen Y, Zhang J, Li D, Mou Y, Chen Z. Adjuvant Temozolomide Chemotherapy With or Without Interferon Alfa Among Patients With Newly Diagnosed High-grade Gliomas: A Randomized Clinical Trial. JAMA Netw Open. 2023 Jan 3;6(1):e2253285. doi: 10.1001/jamanetworkopen.2022.53285.

    PMID: 36705923DERIVED

MeSH Terms

Conditions

AstrocytomaGlioblastomaGlioma

Interventions

Temozolomide

Condition Hierarchy (Ancestors)

Neoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

DacarbazineTriazenesOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Central Study Contacts

Zhong-ping CHEN, MD, PhD

CONTACT

+86-20-87343310chenzhp@sysucc.org.cn

Cheng-cheng GUO, MD, PhD

CONTACT

+86-20-87343309guochch@sysucc.org.cn

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Chair, Department of Neurosurgery

Study Record Dates

First Submitted

January 7, 2013

First Posted

January 10, 2013

Study Start

September 1, 2012

Primary Completion

December 1, 2017

Study Completion

December 1, 2019

Last Updated

February 23, 2018

Record last verified: 2018-02

Locations

CN(1)