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CompletedNCT00782756Updated Feb 6, 2018Results posted

Bevacizumab, Temozolomide and Hypofractionated Radiotherapy for Patients With Newly Diagnosed Malignant Glioma

A Phase 2 interventional study of radiotherapy (RT) in combination with temozolomide and bevacizumab in Brain Cancer and Malignant Glioma, sponsored by Memorial Sloan Kettering Cancer Center. Completed at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-02-06.

Sponsored by Memorial Sloan Kettering Cancer Center · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
40
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study is to test the safety of a new plan for treating glioblastoma. The usual first treatment for glioblastoma is to give focused radiation over 6 weeks in combination with a chemotherapy called temozolomide. In this study the radiation will be given over 2 weeks in combination with temozolomide and another drug, bevacizumab, will also be given. Our idea is that this treatment plan may attack both the tumor and the blood vessels feeding the tumor more effectively. This study will look at what effects, good or bad, this approach has on the patient and the tumor.

02

Conditions studied

  • Brain Cancer
  • Malignant Glioma

Keywords

  • Radiation
  • BEVACIZUMAB
  • AVASTIN
  • TEMOZOLOMIDE
  • newly diagnosed
  • Glioblastoma
  • GBM
  • malignant glioma
  • Radiotherapy
  • 08-126
03

In context

Glioma

1,397 studies on the registry are indexed under Glioma; 351 are open to participants now.

This study's enrollment of 40 is above the median of 32 across 1,065 interventional studies indexed under Glioma.

Browse Glioma studies →

Lead sponsor

Memorial Sloan Kettering Cancer Center is the lead sponsor of 1,930 studies on the registry; 328 are open to participants now.

Of its 129 completed or terminated interventional studies of FDA-regulated products, 66 (51%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Pathologic diagnosis of glioblastoma or grade IV glioma.
  • Tumor volume should be less than 60 cc (approximately 5cm maximum diameter).
  • Age > or = to 18
  • KPS ≥70
  • Granulocyte count >1.5 X 10 9/L
  • Platelet count >99 X 10 9/L
  • SGOT \< 2.5X upper limit of normal (ULN)
  • Serum creatinine \< 2X ULN
  • Bilirubin \< 2X ULN
  • All patients must sign written informed consent

Exclusion criteria

Exclusion Criteria:

  • Any prior chemotherapy, radiotherapy and biologic therapy for glioma.
  • Any prior experimental therapy for glioma.
  • Multicentric glioma
  • Other concurrent active malignancy (with the exception of cervical carcinoma in situ or basal cell ca of the skin).
  • Serious medical or psychiatric illness that would in the opinion of the investigator interfere with the prescribed treatment.
  • Pregnant or breast feeding women.
  • Refusal to use effective contraception
  • Inadequately controlled hypertension (defined as systolic blood pressure >150 mmHg and/or diastolic blood pressure > 100 mmHg)
  • Prior history of hypertensive crisis or hypertensive encephalopathy
  • New York Heart Association (NYHA) Grade II or greater congestive heart failure
  • History of myocardial infarction or unstable angina within 12 months prior to Day 1
  • History of stroke or transient ischemic attack
  • Significant vascular disease (e.g., aortic aneurysm, requiring surgical repair or recent peripheral arterial thrombosis) within 6 months prior to Day 1
  • History of hemoptysis (≥ 1/2 teaspoon of bright red blood per episode) within 1 month prior to Day 1
  • Evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation)
  • Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 1 of treatment or anticipation of need for major surgical procedure during the course of the study
  • Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to Day 1
  • History of abdominal fistula or gastrointestinal perforation within 6 months prior to Day 1
  • Serious, non-healing wound, active ulcer, or untreated bone fracture
  • Proteinuria as demonstrated by a UPC ratio ≥ 1.0 at screening
  • Known hypersensitivity to any component of bevacizumab
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    RT, with temozolomide and bevacizumab

    This treatment regimen is novel in that it delivers the initial course of RT over 2 weeks instead of 6 weeks; also, the addition of bevacizumab during and after RT is a new approach.

    Other: radiotherapy (RT) in combination with temozolomide and bevacizumab

Interventions

  • Otherradiotherapy (RT) in combination with temozolomide and bevacizumab

    Bevacizumab10 mg/kg IV once every two weeks on days 1 and 15 of every cycle (Cycle defined as 28 days). Temozolomide 75mg/m2 daily beginning on day 1 through completion of radiotherapy. Hypofractionated dose painting IMRT will start on day 1 and will be delivered on a Monday, Wednesday, Friday schedule for a total of 6 fractions. Post RT therapy: Bevacizumab 10mg/kg IV every two weeks. Temozolomide 150-200mg/m2 daily for 5 consecutive days will be given on 28 day cycles. Follow up: CBC weekly, comprehensive panel and urinalysis monthly, blood pressure every other week. Neurological/physical examination monthly. Gd-enhanced MRI with perfusion every 2 cycles. Neurocognitive testing (approximately 4months post RT, 1 year after diagnosis and then annually in long term survivors). Blood sample for correlative studies monthly.

06

What researchers measure

Primary outcomes

  1. Number of Participants With Adverse Events

    Safety assessments and toxicity grading will follow CTCAE Version 4 Grade

    Time frame: through study completion, an average of 1 year

Secondary outcomes

  1. Progression Free Survival

    Time frame: through study completion, an average of 1 year

  2. Neurocognitive Outcome

    Time frame: through study completion, an average of 1 year

07

Results

Posted Feb 6, 2018

Participant flow

Participant flow — Overall Study
MilestoneRT, With Temozolomide and Bevacizumab
Started40
Completed40
Not completed0

Outcome measures

PrimaryNumber of Participants With Adverse Events

Safety assessments and toxicity grading will follow CTCAE Version 4 Grade

Time frame:
through study completion, an average of 1 year
Reported as:
Count of participants · Participants
Number of Participants With Adverse Events
ParticipantsRT, With Temozolomide and Bevacizumab
Number of Participants With Adverse Events40
SecondaryProgression Free Survival
Time frame:
through study completion, an average of 1 year
Reported as:
Median · months
Progression Free Survival
monthsRT, With Temozolomide and Bevacizumab
Progression Free Survival10 (8 to 11)
SecondaryNeurocognitive Outcome
Time frame:
through study completion, an average of 1 year
Reported as:
Count of participants · Participants
Neurocognitive Outcome
ParticipantsRT, With Temozolomide and Bevacizumab
Neuropsychological evaluations37
Did not agree to neuropsychological evaluations3

Adverse events

Collected over 1 year. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
RT, With Temozolomide and Bevacizumab40/40 (100%)19/40 (47.5%)40/40 (100%)
Most frequent serious events
Showing 10 of 24
Most frequent serious events
EventRT, With Temozolomide and Bevacizumab
SeizureNervous system disorders13/40
PlateletsInvestigations6/40
NauseaGastrointestinal disorders3/40
Thrombosis/thrombus/embolismVascular disorders3/40
Thrombotic microangiopathyBlood and lymphatic system disorders3/40
VomitingGastrointestinal disorders3/40
CreatinineInvestigations2/40
Infection, otherInfections and infestations2/40
Neutrophils/granulocytes (ANC/AGC)Investigations2/40
Pain - Head/headacheNervous system disorders2/40
Most frequent other events
Showing 10 of 30
Most frequent other events
EventRT, With Temozolomide and Bevacizumab
FatigueGeneral disorders29/40
ConstipationGastrointestinal disorders18/40
NauseaGastrointestinal disorders15/40
Mucositis oralGastrointestinal disorders12/40
HeadacheNervous system disorders10/40
AnorexiaMetabolism and nutrition disorders7/40
DiarrheaGastrointestinal disorders6/40
Hemorrhage/Bleeding - otherInjury, poisoning and procedural complications4/40
HypertensionVascular disorders4/40
VomitingGastrointestinal disorders4/40

Baseline characteristics

Age, Continuous
Age, Continuous(years)RT, With Temozolomide and Bevacizumab
Median55 (18 to 75)
Sex: Female, Male
Sex: Female, Male(Participants)RT, With Temozolomide and Bevacizumab
Female14
Male26
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)RT, With Temozolomide and Bevacizumab
Hispanic or Latino0
Not Hispanic or Latino40
Unknown or Not Reported0
Race (NIH/OMB)
Race (NIH/OMB)(Participants)RT, With Temozolomide and Bevacizumab
American Indian or Alaska Native0
Asian1
Native Hawaiian or Other Pacific Islander0
Black or African American0
White36
More than one race0
Unknown or Not Reported3
Region of Enrollment
Region of Enrollment(Participants)RT, With Temozolomide and Bevacizumab
United States40
08

Study locations

3 sites
  • Memoral Sloan Kettering Cancer Center
    Basking Ridge, New Jersey, United States
  • Memorial Sloan-Kettering Cancer Center at Commack
    Commack, New York 11725, United States
  • Memorial Sloan-Kettering Cancer Center
    New York, New York 10065, United States
09

References and documents

Study documents

  • Protocol and statistical analysis plan · Apr 28, 2009

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 6, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00782756
Lead sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
Genentech, Inc., National Institutes of Health (NIH)
Responsible party
Sponsor
First posted
Oct 31, 2008
Start date
Oct 28, 2008
Primary completion
Mar 23, 2017
Completion
Mar 23, 2017
Results posted
Feb 6, 2018
Last update
Feb 6, 2018

Study contacts

Antonio Omuro, MD
principal investigator · Memorial Sloan Kettering Cancer Center

Oversight

FDA-regulated drug
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.

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