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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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights

Study 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.Check my eligibility
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.See study design
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 below
Select...
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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Dose-limiting toxicities (DLTs) (Phase I)
Incidence of adverse events
Overall survival (OS) (Phase II)
Secondary outcome measures
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
~1930
Atezolizumab
2016
Completed Phase 3
~6040
Radiation Therapy
2017
Completed Phase 3
~7250

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,958 Previous Clinical Trials
1,798,369 Total Patients Enrolled
42 Trials studying Glioblastoma
1,889 Patients Enrolled for Glioblastoma
National Cancer Institute (NCI)NIH
13,611 Previous Clinical Trials
40,915,934 Total Patients Enrolled
314 Trials studying Glioblastoma
22,366 Patients Enrolled for Glioblastoma
Shiao-Pei S WeathersPrincipal InvestigatorM.D. Anderson Cancer Center
4 Previous Clinical Trials
173 Total Patients Enrolled
3 Trials studying Glioblastoma
123 Patients Enrolled for Glioblastoma

Media Library

Atezolizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03174197 — Phase 1 & 2
Glioblastoma Research Study Groups: Adjuvant phase (temozolomide, atezolizumab), Concurrent phase (temozolomide, atezolizumab, RT)
Glioblastoma Clinical Trial 2023: Atezolizumab Highlights & Side Effects. Trial Name: NCT03174197 — Phase 1 & 2
Atezolizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03174197 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What types of ailments are commonly addressed by Radiation Therapy?

"Radiation Therapy is a viable treatment for many conditions, including advanced directives and small cell lung cancer (SCLC). It can also be used to combat the progression of disease in combination with pharmacotherapy."

Answered by AI

Is this an unprecedented clinical research endeavor?

"Presently, 554 Radiation Therapy studies are underway across 1812 cities in 74 nations. The initial trial occurred back in 2002, when Schering-Plough conducted a Phase 2 drug approval study on 60 patients. Since then, 472 clinical trials have concluded their testing phases."

Answered by AI

Are there any openings for individuals to participate in this research study?

"As per clinicaltrials.gov, this research study is not presently accepting new participants. Initially posted on June 30th 2017 and last updated on September 14th 2022, the trial unfortunately does not require additional enrollees at this time; however there are 997 other trials actively seeking volunteers right now."

Answered by AI

What is the participant count of this research endeavor?

"This investigation has concluded its recruitment phase, with the trial's initial post on June 30th 2017 and last edit falling on September 14th 2022. Should you be seeking additional clinical research opportunities, there are 443 studies involving glioblastoma currently accepting enrolment as well as 554 Radiation Therapy trials that remain open for participation."

Answered by AI

What other research endeavors have been conducted concerning Radiation Therapy?

"Currently, 554 Radiation Therapy trials are in progress with 94 of them being Phase 3 studies. Houston is the hub for most research related to this therapeutic approach; however, it can be accessed at 23116 sites around the country."

Answered by AI
~12 spots leftby Jun 2025