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NCT Number: NCT01985087

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Glioblastoma Astrocytoma Glioma Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neuroectodermal Tumors

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

James Graham Brown Cancer Center

Louisville, Kentucky, 40202, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants must have histologically confirmed glioblastoma/gliosarcoma.
  • Tumor o6-methylguanine-DNA-methyltransferase promoter methylation status must be determined
  • Participants must not have had any prior therapy for glioblastoma multiforme including radiation or chemotherapy.
  • Participants must be > 70 years of age.
  • Participants must have life expectancy greater than 6 months.
  • Karnofsky performance status > 60 (ECOG < 2).
  • 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
  • Ability to understand and the willingness to sign a written informed consent document.

Exclusion criteria

  • Participants may not be receiving any other study agents.
  • Participants may not have had chemotherapy wafer placement at surgery.
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to temozolomide.
  • 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.
  • 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.
  • 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.

Treatment and study plan

Hypofractionated radiotherapy

Radiation

Treatment of 3.4 Gy will be given daily 5 days per week over 2 weeks.

Temozolomide

Drug

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 names: Brand name Temodar

Primary outcomes

  1. Number of patients who stop treatment due to Common Terminology Criteria for Adverse Events (CTCAE) grade 3 or above toxicities..

    Time frame: baseline, 14-28 days post-surgery, 4 weeks post chemo-radiation therapy, 1, 2, 3, 4, 5, and 6 months post Radiation Therapy

    If < 4 out of 10 patients in the initial analysis stop treatment due to toxicity it can proceed to phase II.

  2. Overall survival

    Time frame: From date of intervention until the date of first documented disease progression or death, the date of study discontinuation (e.g. toxicity, PI decision) or death from any cause, whichever is first, assessed up to 100 months.

    Survival status will be collected after completion of chemo-radiation at minimum every 3 months for up to 12 months, then every 6 months until date of death.

Secondary outcomes

  1. Estimate progression-free survival (PFS)

    Time frame: From date of intervention until the date of first documented disease progression or death, the date of study discontinuation (e.g. toxicity, PI decision) or death from any cause, whichever is first, assessed up to 100 months.

    Survival/Documentation of progressive disease status will be collected every 3 months post chemo-radiation up to 12 months, then every 6 months until death, or from the date of disease progression, the date of study discontinuation (e.g. toxicity, PI decision), or from the date of the last dose of study drug (concomitant or adjuvant) if no disease progression.

  2. Tolerability (feasibility) of hypo-fractionated radiaton therapy and Temozolomide

    Time frame: From date of intervention until the date of first documented disease progression or death, the date of study discontinuation (e.g. toxicity, PI decision) or death from any cause, whichever is first, assessed up to 100 months.

    Quality of life will be measured by Fact-BR assessment.

Other outcomes

  1. Explore association of Overall Survival (OS) and Progression Free Survival (PFS) with 06-methylguanine-DNA methyltransferase gene (MGMT) methylation status

    Time frame: From date of intervention until the date of first documented disease progression or death, the date of study discontinuation (e.g. toxicity, PI decision) or death from any cause, whichever is first, assessed up to 100 months.

    Survival/Documentation of progressive disease status will be collected 4-weeks post chemo-radiation therapy then every 3 months up to 12 months, then every 6 months until death, from either the date of disease progression, the date of study discontinuation (e.g. toxicity, PI decision), or from the date of the last dose of study drug (concomitant or adjuvant) if no disease progression.

  2. Explore changes in quality of life (QOL)

    Time frame: 14-28 days after surgery then within 4 weeks from end of chemotherapy-radiation then 1,4, and 6 months post initiation of adjuvant treatment

    To explore changes in QOL measured by Functional Assessment of Cancer Therapy (FACT-BR) and its predictors.

Sponsors and collaborators

Lead sponsor

University of Louisville

Other

Collaborators

  • James Graham Brown Cancer Center

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2025
Study completion
2025
First posted
Nov 15, 2013
Registry last updated
Oct 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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