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A Phase III Trial on Adjuvant Temozolomide With or Without Interferon-alpha in Newly Diagnosed High-grade Gliomas

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2015 by Sun Yat-sen University
Sponsor:
Collaborators:
Fudan University
West China Hospital
Tianjin Medical University Cancer Institute and Hospital
Chinese Academy of Medical Sciences
Information provided by (Responsible Party):
Zhongping Chen, Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT01765088
First received: January 7, 2013
Last updated: December 10, 2015
Last verified: December 2015
  Purpose
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.

Condition Intervention Phase
Anaplastic Oligoastrocytoma
Anaplastic Astrocytoma
Glioblastoma
Drug: Temozolomide
Drug: α-IFN
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase III Trial on Adjuvant Standard Temozolomide Chemotherapy With or Without Interferon-alpha in Newly Diagnosed High-grade Gliomas

Resource links provided by NLM:


Further study details as provided by Sun Yat-sen University:

Primary Outcome Measures:
  • Over-all survival [ Time Frame: 5-year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quality of life [ Time Frame: 5-year ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: September 2012
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: temozolomide
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
dosed at 200 mg/m2 (150 mg/m2 for the first cycle) daily for 5 consecutive days, repeated every 28 days
Other Name: Temodar
Experimental: temozolomide +α-IFN
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: Temozolomide
dosed at 200 mg/m2 (150 mg/m2 for the first cycle) daily for 5 consecutive days, repeated every 28 days
Other Name: Temodar
Drug: α-IFN
3mIU (3million) D1,3,5
Other Name: INTRONA

Detailed Description:
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. Four weeks after radiotherapy, newly diagnosed WHO III-IV glioma patients will be randomised into two groups: TMZ group or TMZ+ α-IFN groups.
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01765088

Contacts
Contact: Zhong-ping CHEN, MD, PhD +86-20-87343310 chenzhp@sysucc.org.cn
Contact: Cheng-cheng GUO, MD, PhD +86-20-87343309 guochch@sysucc.org.cn

Locations
China, Guangdong
Sun Yat-sen University Cancer Center Recruiting
Guangzhou, Guangdong, China, 510060
Contact: Zhong-ping Chen, MD,PhD    +86-20-87343310    chenzhp@sysucc.org.cn   
Contact: Cheng-cheng Guo, MD,PhD    +86-20-87343656    guochch@sysucc.org.cn   
Principal Investigator: Zhong-ping Chen, MD,PhD         
Sponsors and Collaborators
Sun Yat-sen University
Fudan University
West China Hospital
Tianjin Medical University Cancer Institute and Hospital
Chinese Academy of Medical Sciences
  More Information

Responsible Party: Zhongping Chen, Professor and Chair, Department of Neurosurgery, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT01765088     History of Changes
Other Study ID Numbers: CSNO2012001 
Study First Received: January 7, 2013
Last Updated: December 10, 2015
Health Authority: China: Food and Drug Administration

Keywords provided by Sun Yat-sen University:
High-grade glioma
chemotherapy
Temozolomide
Interferon-alpha

Additional relevant MeSH terms:
Glioblastoma
Glioma
Astrocytoma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Temozolomide
Interferons
Dacarbazine
Interferon-alpha
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 29, 2016