Bevacizumab, Temozolomide and Hypofractionated Radiotherapy for Patients With Newly Diagnosed Malignant Glioma
This study is ongoing, but not recruiting participants.
Sponsor:
Memorial Sloan Kettering Cancer Center.
Collaborators:
Genentech, Inc.
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center.
ClinicalTrials.gov Identifier:
NCT00782756
First received: October 29, 2008
Last updated: July 21, 2014
Last verified: July 2014
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Brain Cancer Malignant Glioma |
Other: radiotherapy (RT) in combination with temozolomide and bevacizumab |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Study of Bevacizumab, Temozolomide and Hypofractionated Radiotherapy for Patients With Newly Diagnosed Malignant Glioma |
Resource links provided by NLM:
Further study details as provided by Memorial Sloan Kettering Cancer Center.:
Primary Outcome Measures:
- To test the safety and efficacy of bevacizumab and temozolomide in combination with hypo-fractionated radiotherapy inpatients with newly diagnosed glioblastoma in terms of improvements in overall survival. [ Time Frame: conclusion of the study ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Progression free survival [ Time Frame: conclusion of the study ] [ Designated as safety issue: No ]
- Neurocognitive outcome [ Time Frame: conclusion of the study ] [ Designated as safety issue: No ]
| Enrollment: | 40 |
| Study Start Date: | October 2008 |
| Estimated Study Completion Date: | October 2015 |
| Estimated Primary Completion Date: | October 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
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. |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00782756
Please refer to this study by its ClinicalTrials.gov identifier: NCT00782756
Locations
| United States, New Jersey | |
| Memoral Sloan Kettering Cancer Center | |
| Basking Ridge, New Jersey, United States | |
| United States, New York | |
| Memorial Sloan-Kettering Cancer Center at Commack | |
| Commack, New York, United States, 11725 | |
| Memorial Sloan-Kettering Cancer Center | |
| New York, New York, United States, 10065 | |
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center.
Genentech, Inc.
Investigators
| Principal Investigator: | Antonio Omuro, MD | Memorial Sloan Kettering Cancer Center. |
More Information
Additional Information:
No publications provided
| Responsible Party: | Memorial Sloan Kettering Cancer Center. |
| ClinicalTrials.gov Identifier: | NCT00782756 History of Changes |
| Other Study ID Numbers: | 08-126 |
| Study First Received: | October 29, 2008 |
| Last Updated: | July 21, 2014 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Memorial Sloan Kettering Cancer Center.:
|
Radiation BEVACIZUMAB AVASTIN TEMOZOLOMIDE newly diagnosed |
Glioblastoma GBM malignant glioma Radiotherapy 08-126 |
Additional relevant MeSH terms:
|
Glioma Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neuroectodermal Tumors Bevacizumab Dacarbazine Temozolomide |
Alkylating Agents Angiogenesis Inhibitors Angiogenesis Modulating Agents Antineoplastic Agents Antineoplastic Agents, Alkylating Growth Inhibitors Growth Substances Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Therapeutic Uses |
ClinicalTrials.gov processed this record on March 02, 2015