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A Study Using Radiation Therapy and Temozolomide to Treat Glioblastoma in Patients Over 70

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ClinicalTrials.gov Identifier: NCT01985087
Recruitment Status : Recruiting
First Posted : November 15, 2013
Last Update Posted : January 16, 2019
Sponsor:
Collaborator:
James Graham Brown Cancer Center
Information provided by (Responsible Party):
Shiao Yuo Woo, University of Louisville

Study Description
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Brief Summary:
In this study we propose to determine outcomes of patients age 70 or older treated with radiation over 2 weeks given with temozolomide 75 mg/m2 daily during radiotherapy and as a post radiation treatment of 150 mg/m2 - 200 mg /m2 for 6 cycles or until the disease progresses.

Condition or disease Intervention/treatment Phase
Glioblastoma Radiation: Hypofractionated radiotherapy Drug: Temozolomide Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/ II Study of Hypofractionated Radiotherapy With Concurrent Temozolomide Followed by Adjuvant Temozolomide in Patients Over 70 Years Old With Newly Diagnosed Glioblastoma
Study Start Date : September 2014
Estimated Primary Completion Date : May 2025
Estimated Study Completion Date : May 2025

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Hypofractionated radiotherapy and temozolomide
All subjects will receive treatment as is a single arm study. Two weeks of combined hypofractionated radiotherapy with concurrent temozolomide followed by up to 6 cycles of adjuvant temozolomide treatment.
 Radiation: Hypofractionated radiotherapy
Treatment of 3.4 Gy will be given daily 5 days per week over 2 weeks.

Drug: Temozolomide
During concomitant phase Temozolomide will be administered orally at 75 mg/m2 for 2 weeks concomitant with radiotherapy. During the adjuvant phase Temozolomide will be administered orally at 150 mg/m2 on days 1 through day 5 of each 28 day cycle for a maximum of 6 cycles.
Other Name: brand name Temodar


Outcome Measures
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Primary Outcome Measures :
  1. Number of patients who stop treatment due to CTCAE grade 3 or above toxicities [ Time Frame: 4 weeks after radiation therapy - month 6 ]
    If < 4 out of 10 patients in the initial analysis stop treatment due to toxicity it can proceed to phase II.


Secondary Outcome Measures :
  1. Overall survival [ Time Frame: from study enrollment to date of death or up to approximately 5 years ]
  2. Quality of Life [ Time Frame: 7 months after enrollment ]
    Quality of life will be measured by Fact-BR assessment.

  3. The number of patients to complete RT+TMZ and a minimum of 3 of the 6 planned cycles of adjuvant chemotherapy [ Time Frame: 7 months after enrollment ]

Eligibility Criteria
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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Participants must have histologically confirmed glioblastoma/gliosarcoma.
  2. Tumor o6-methylguanine-DNA-methyltransferase promoter methylation status must be determined
  3. Participants must not have had any prior therapy for glioblastoma multiforme including radiation or chemotherapy.
  4. Participants must be > 70 years of age.
  5. Participants must have life expectancy greater than 6 months.
  6. Karnofsky performance status > 60 (ECOG < 2).

  7. Patients must have normal organ and marrow function

    • Leukocytes > 3,000/microliter
    • Absolute neutrophil count > 1,500/microliter
    • Platelets > 100,000/microliter
    • Total bilirubin within normal institutional limits 12
    • aspartate aminotransferase test(SGOT)/alanine aminotransferase test(SGPT) < 2.5 X institutional upper limit of normal
    • Creatinine within normal institutional limits or creatinine clearance > 60 mL/min/1.73 m2 for subjects with creatinine levels about institutional normal
  8. Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

  1. Participants may not be receiving any other study agents.
  2. Participants may not have had chemotherapy wafer placement at surgery.
  3. History of allergic reactions attributed to compounds of similar chemical or biologic composition to temozolomide.
  4. Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  5. Individuals with a history of a different malignancy are ineligible except for the following circumstances. Individuals with a history of other malignancies are eligible if they have been disease-free for at least 3 years and are deemed by the investigator to be at low risk for recurrence of that malignancy. Individuals with the following cancers are eligible if diagnosed and treated within the past 5 years: cervical cancer in situ, and basal cell or squamous cell carcinoma of the skin.
  6. HIV-positive individuals on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with temozolomide. In addition, these individuals are at increased risk of lethal infections when treated with marrow-suppressive therapy. Appropriate studies will be undertaken in participants receiving combination antiretroviral therapy when indicated.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01985087


Locations
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United States, Kentucky
James Graham Brown Cancer Center Recruiting
Louisville, Kentucky, United States, 40202
Contact: Clinical Trials Office    502-562-3429    ctobcc@louisville.edu   
Principal Investigator: Shiao Woo, MD         
Sponsors and Collaborators
University of Louisville
James Graham Brown Cancer Center
Investigators
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Principal Investigator: Shiao Woo, MD James Graham Brown Cancer Center
More Information
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Responsible Party: Shiao Yuo Woo, Associate Professor, University of Louisville
ClinicalTrials.gov Identifier: NCT01985087     History of Changes
Other Study ID Numbers: BCC-NEU-13 GB70
First Posted: November 15, 2013    Key Record Dates
Last Update Posted: January 16, 2019
Last Verified: January 2019
Additional relevant MeSH terms:
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Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
 Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Temozolomide
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents