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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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:

  • - 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT00782756
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Memorial Sloan Kettering Cancer Center
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Antonio Omuro, MD
Principal Investigator Affiliation Memorial Sloan Kettering Cancer Center
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other, Industry, NIH
Overall Status Completed
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Brain Cancer, Malignant Glioma
Arms & Interventions

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.

Interventions

Other: - radiotherapy (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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Memoral Sloan Kettering Cancer Center, Basking Ridge, New Jersey

Status

Address

Memoral Sloan Kettering Cancer Center

Basking Ridge, New Jersey,

Commack, New York

Status

Address

Memorial Sloan-Kettering Cancer Center at Commack

Commack, New York, 11725

Memorial Sloan-Kettering Cancer Center, New York, New York

Status

Address

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065