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Monoclonal Antibodies
Immunotherapy + Chemotherapy + Radiation for Glioblastoma
Phase 1 & 2
Waitlist Available
Led By Shiao-Pei S Weathers
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients must have undergone surgery and must not have had any further treatment following surgery
Have a performance status of >= 60 on the Karnofsky performance status (KPS)
Must not have
Received oral or IV antibiotics within 2 weeks prior to cycle 1, day 1
History of idiopathic pulmonary fibrosis, pneumonitis, organizing pneumonia, or evidence of active pneumonitis on screening chest computed tomography (CT) scan
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
Summary
This trial is testing a combination of immunotherapy, chemotherapy, and radiation therapy to treat patients with glioblastoma.
Who is the study for?
This trial is for patients with newly diagnosed glioblastoma who have had surgery but no other treatment. They must start treatment within 6 weeks of surgery, have adequate blood counts and organ function, not be pregnant or breastfeeding, agree to use contraception, and have a performance status indicating they can care for themselves.
What is being tested?
The study tests how well the combination of atezolizumab (an immune system-boosting drug), temozolomide (a chemotherapy drug), and radiation therapy works in treating glioblastoma. It's a phase I/II trial to assess side effects and effectiveness.
What are the potential side effects?
Potential side effects include reactions related to the immune system such as inflammation in organs, infusion-related reactions from atezolizumab; nausea, fatigue, hair loss from temozolomide; and skin irritation or damage to nearby tissues from radiation.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I had surgery for my condition and have not received any treatment since.
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I am mostly able to care for myself and carry out daily activities.
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My kidney function, measured by creatinine levels, is within the normal range.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have not taken any antibiotics in the last 2 weeks.
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I have a history of lung scarring or inflammation.
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I have active tuberculosis.
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I expect to need a major surgery during the study.
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I have had cancer treatments directly in the tumor area but not Gliadel wafers or Optune device.
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I am currently being treated for an infection.
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I haven't taken any immune-boosting drugs in the last 6 weeks or five half-lives of the drug.
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I have not had severe infections or been hospitalized for infection complications in the last 4 weeks.
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I haven't taken any immune-weakening medications in the last 2 weeks.
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I have been treated with drugs targeting PD-1 or PD-L1.
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I have a history of HIV or active hepatitis B or C.
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I have a lung condition not caused by an infection.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Dose-limiting toxicities (DLTs) (Phase I)
Incidence of adverse events
Overall survival (OS) (Phase II)
Secondary study objectives
Duration of response (DoR)
Overall response rate
Progression-free survival (PFS)
Trial Design
2Treatment groups
Experimental Treatment
Group I: Concurrent phase (temozolomide, atezolizumab, RT)Experimental Treatment3 Interventions
Patients receive temozolomide PO daily on days 1-42 and atezolizumab IV over 30-60 minutes on day 1, 15, 29, and 42. Patients undergo RT 5 days per week (Monday-Friday) for 6 weeks in the absence of disease progression or unacceptable toxicity.
Group II: Adjuvant phase (temozolomide, atezolizumab)Experimental Treatment2 Interventions
Patients receive temozolomide PO on days 1-5 and atezolizumab IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Temozolomide
2010
Completed Phase 3
~1880
Atezolizumab
2017
Completed Phase 3
~5850
Radiation Therapy
2017
Completed Phase 3
~7250
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
3,039 Previous Clinical Trials
1,799,621 Total Patients Enrolled
43 Trials studying Glioblastoma
1,746 Patients Enrolled for Glioblastoma
National Cancer Institute (NCI)NIH
13,842 Previous Clinical Trials
41,002,920 Total Patients Enrolled
326 Trials studying Glioblastoma
23,102 Patients Enrolled for Glioblastoma
Shiao-Pei S WeathersPrincipal InvestigatorM.D. Anderson Cancer Center
4 Previous Clinical Trials
86 Total Patients Enrolled
3 Trials studying Glioblastoma
36 Patients Enrolled for Glioblastoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not taken any antibiotics in the last 2 weeks.I am not receiving any other cancer treatments while on this study.I have active tuberculosis.I have not had signs of infection in the last 2 weeks.I do not have any health conditions that would make it unsafe for me to take a new drug.I expect to need a major surgery during the study.I had surgery for my condition and have not received any treatment since.I have had cancer treatments directly in the tumor area but not Gliadel wafers or Optune device.I will start treatment within 6 weeks after my surgery.I agree to use birth control during the study.I do not have any serious health issues that would prevent me from following the study's procedures.I am currently being treated for an infection.I haven't taken any immune-boosting drugs in the last 6 weeks or five half-lives of the drug.I've had a brain MRI within the last 2 weeks and am on a low or reducing dose of steroids.I haven't had any other cancers in the last 5 years, except for those considered low risk and curable.My diagnosis is grade IV glioma, confirmed by tissue analysis.I am mostly able to care for myself and carry out daily activities.I have not had severe infections or been hospitalized for infection complications in the last 4 weeks.I have not received a live vaccine in the last 4 weeks and do not plan to during the study.I haven't taken any immune-weakening medications in the last 2 weeks.My kidney function, measured by creatinine levels, is within the normal range.I am a woman who can have children and have a recent negative pregnancy test.I am using two birth control methods or am not having sex to avoid pregnancy during the study.I have a history of lung scarring or inflammation.I have multiple brain tumors that need different treatment areas.I have been treated with drugs targeting PD-1 or PD-L1.I have a history of HIV or active hepatitis B or C.I have a lung condition not caused by an infection.
Research Study Groups:
This trial has the following groups:- Group 1: Adjuvant phase (temozolomide, atezolizumab)
- Group 2: Concurrent phase (temozolomide, atezolizumab, RT)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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