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

NCT01985087 | Active Not Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: 13.0538 BCC-NEU-13 GB70
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Glioblastoma

Outcome Measures

Primary Outcomes (2)

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

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

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

• Overall survival

  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.

  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.

Secondary Outcomes (2)

• Estimate progression-free survival (PFS)

  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.

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

  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.

Other Outcomes (2)

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

  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.

• Explore changes in quality of life (QOL)

  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

Study Arms (1)

Hypofractionated radiotherapy and temozolomide

EXPERIMENTAL

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; Drug: Temozolomide

Interventions

Hypofractionated radiotherapy RADIATION

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

Hypofractionated radiotherapy and temozolomide

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.

Also known as: Brand name Temodar

Hypofractionated radiotherapy and temozolomide

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Louisville: lead
• James Graham Brown Cancer Center: collaborator

Study Sites (1)

James Graham Brown Cancer Center

Louisville, Kentucky, 40202, United States

Location

MeSH Terms

Conditions

Glioblastoma

Interventions

Radiation Dose Hypofractionation; Temozolomide

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Dose Fractionation, Radiation; Radiotherapy Dosage; Radiotherapy; Therapeutics; Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Shiao Woo, MD

  James Graham Brown Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 10, 2013
• First Posted: November 15, 2013
• Study Start: September 1, 2014
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: October 31, 2024

Record last verified: 2024-10

Locations

US (1)