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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE October 10, 2013
First Posted Date  ICMJE November 15, 2013
Last Update Posted Date January 16, 2019
Study Start Date  ICMJE September 2014
Estimated Primary Completion Date May 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 14, 2013)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01985087 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 14, 2013)
  • Overall survival [ Time Frame: from study enrollment to date of death or up to approximately 5 years ]
  • Quality of Life [ Time Frame: 7 months after enrollment ]
    Quality of life will be measured by Fact-BR assessment.
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study Using Radiation Therapy and Temozolomide to Treat Glioblastoma in Patients Over 70
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Glioblastoma
Intervention  ICMJE
  • 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
Study Arms  ICMJE 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.
Interventions:
  • Radiation: Hypofractionated radiotherapy
  • Drug: Temozolomide
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 14, 2013)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2025
Estimated Primary Completion Date May 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 70 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01985087
Other Study ID Numbers  ICMJE BCC-NEU-13 GB70
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Shiao Yuo Woo, University of Louisville
Study Sponsor  ICMJE University of Louisville
Collaborators  ICMJE James Graham Brown Cancer Center
Investigators  ICMJE
Principal Investigator: Shiao Woo, MD James Graham Brown Cancer Center
PRS Account University of Louisville
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP