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

NCT ID: NCT01985087

Last Updated: 2024-10-31

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2025-05-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Hypofractionated radiotherapy

Intervention Type: RADIATION

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

Temozolomide

Intervention Type: 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.

Interventions

Hypofractionated radiotherapy

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

Intervention Type: RADIATION

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.

Intervention Type: DRUG

Other Intervention Names

Brand name Temodar

Eligibility 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.

• Minimum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

James Graham Brown Cancer Center

OTHER

Sponsor Role: collaborator

University of Louisville

OTHER

Sponsor Role: lead

Responsible Party

Adrianna H Masters

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shiao Woo, MD

Role: PRINCIPAL_INVESTIGATOR

James Graham Brown Cancer Center

Locations

James Graham Brown Cancer Center

Louisville, Kentucky, United States

Countries

United States

Other Identifiers

13.0538 BCC-NEU-13 GB70

Identifier Type: -

Identifier Source: org_study_id