Radiation + Temozolomide for Glioblastoma

Age: 65+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: University of Louisville

Must be taking: Temozolomide

Must not be taking: Antiretrovirals

Disqualifiers: Infection, Heart failure, Angina, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

18 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

Shiao Woo, MD

Principal Investigator

James Graham Brown Cancer Center

Are You a Good Fit for This Trial?

This trial is for patients over 70 with newly diagnosed glioblastoma who haven't had prior treatments. They must have a life expectancy of more than 6 months, good organ and marrow function, and be able to consent. Excluded are those with other cancers (unless low risk or certain types within the past 5 years), severe illnesses, or HIV on antiretrovirals.

Inclusion Criteria

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, 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 above institutional normal, Ability to understand and the willingness to sign a written informed consent document

Participants must have life expectancy greater than 6 months

I am over 70 years old.

Exclusion Criteria

History of allergic reactions attributed to compounds of similar chemical or biologic composition to temozolomide

Participants may not be receiving any other study agents

I have not had chemotherapy wafers placed during surgery.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation

Participants receive hypofractionated radiotherapy with concurrent temozolomide

2 weeks

Daily visits for radiation therapy

Adjuvant Treatment

Participants receive up to 6 cycles of adjuvant temozolomide treatment

6 months

Monthly visits for each cycle

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Every 3 months for the first year, then every 6 months

What Are the Treatments Tested in This Trial?

Interventions

• Hypofractionated radiotherapy
• Temozolomide

Trial Overview The study tests a combination of short-term radiation therapy (over two weeks) and Temozolomide chemotherapy during and after radiation in older adults. The goal is to see how well they tolerate this treatment regimen and its effectiveness against their brain cancer.

How Is the Trial Designed?

Group I: Hypofractionated radiotherapy and temozolomide Experimental Treatment 2 Interventions

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.

Hypofractionated radiotherapy is already approved in European Union, United States, Japan for the following indications:

Approved in European Union as Hypofractionated radiotherapy for:

• Esophageal adenocarcinoma
• Gastroesophageal junction adenocarcinoma

Approved in United States as Hypofractionated radiotherapy for:

• Esophageal adenocarcinoma
• Gastroesophageal junction adenocarcinoma

Approved in Japan as Hypofractionated radiotherapy for:

• Esophageal squamous cell carcinoma
• Esophageal adenocarcinoma

Who Is Running the Clinical Trial?

University of Louisville

Lead Sponsor

Trials

353

Recruited

76,400+

James Graham Brown Cancer Center

Collaborator

Trials

44

Recruited

9,200+