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

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:

MedlinePlus related topics: Cancer

Drug Information available for: Interferon Interferon Alfa-2a Temozolomide

U.S. FDA Resources

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:	September 2015
Estimated Primary Completion Date:	September 2014 (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
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

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

No publications provided

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:	January 9, 2013
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:

Astrocytoma
Glioblastoma
Glioma
Oligodendroglioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Interferon-alpha
Interferon Alfa-2a
Interferons
Temozolomide

Dacarbazine
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 23, 2013