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Sunitinib, Temozolomide and Radiation Therapy for Glioblastoma

Phase 2
Waitlist Available
Research Sponsored by Bassam Abdulkarim
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months post treatment
Awards & highlights

Study Summary

The purpose of this study is to determine whether a combination of Sunitinib, Temozolomide and Radiation Therapy would be effective in the treatment of newly diagnosed Glioblastoma patients harboring tumors with unmethylated MGMT promoter.

Eligible Conditions
  • Glioblastoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months post treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months post treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Tumor Response Rate
Secondary outcome measures
Adverse Events
Biomarkers (Cytokines) response
Increase use of corticosteroids
+3 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Sunitinib, Temozolomide and Radiation TherapyExperimental Treatment3 Interventions
Before concurrent treatment, patients will receive sunitinib orally at a dose of 12.5 mg once daily for one week prior to radiation. Patients will then receive a concomitant treatment of sunitinib at a dose of 12.5 mg once daily along with temozolomide (75 mg/m2 daily) along with radiotherapy (60 Gy in 30 fractions) over a period of 6 weeks. This concurrent treatment of sunitinib, temozolomide and radiotherapy is followed by a 1 month break after which the adjuvant temozolomide treatment is administered at a dose of 150/200mg/m2 daily, for 5 of 28 days over a period of 6 months.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Radiation Therapy
2017
Completed Phase 3
~7250
Sunitinib
FDA approved
Temozolomide
FDA approved

Find a Location

Who is running the clinical trial?

Bassam AbdulkarimLead Sponsor
PfizerIndustry Sponsor
4,566 Previous Clinical Trials
10,908,080 Total Patients Enrolled
25 Trials studying Glioblastoma
910 Patients Enrolled for Glioblastoma
Canadian Cancer Society (CCS)OTHER
78 Previous Clinical Trials
37,700 Total Patients Enrolled
2 Trials studying Glioblastoma
78 Patients Enrolled for Glioblastoma

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Combining Sunitinib, Temozolomide and Radiation to Treat Patients Diagnosed With Glioblastoma
Bassam Abdulkarim 2012. "Combining Sunitinib, Temozolomide and Radiation to Treat Patients Diagnosed With Glioblastoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02928575.
All > Sutent
~4 spots leftby Apr 2025
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