MDACC Study Summary 2006-0890 (Archived)

Study Summary
No. 2006-0890:.......Brain; CNS......Monica Loghin......Neuro Oncology

Study Summary Title



Study Summary Number:	2006-0890

Study Title:	A Randomized Phase II Trial of Bevacizumab to Control Brain Radiation Damage

Physician

New Patient Referral



Name:	Monica Loghin	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Neuro Oncology	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-792-2883 Contact us about clinical trials

General Information



Disease Group:	Brain CNS	Supported By:	N/A

Phase of Study:	Phase II	Return Visit:	every 3 weeks

Treatment Agents:	Avastin Placebo	Home Care:	N/A

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:	N/A


Description/ Intervention:	Unavailable

Study Objectives / Outcomes

1. Primary Objectives

Determine to what extent IV bevacizumab given every 3 weeks can reduce active radiation toxicity to the central nervous system

2. Secondary Objectives

Determine to what extent IV bevacizumab given every 3 weeks can reduce dexamethasone dependence (daily dose) in patients with active radiation toxicity

Determine to what extent IV bevacizumab given every 3 weeks can improve neurologic function in patients with active radiation toxicity

Determine to what extent IV bevacizumab given every three weeks can improve quality-of-life in patients with active radiation toxicity

Study Status Information



Study Activation / Registration Date:	06/20/2007

IRB Review and Approval Date:	06/20/2007

Study Type:	Phase Ii Or Phase I/Ii

Recruitment Status:	Terminated

Projected Accrual:	N/A

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:

1) Patients must have received cranial irradiation for histologically confirmed WHO grade 2-3 primary brain neoplasm, meningioma, or head and neck cancer.

2) Prior irradiation >/= 6 months prior to study entry.

3) Radiographic evidence to support the diagnosis of radiation necrosis and/or surgical biopsy evidence of necrosis without tumor </= 2 months of study entry.

4) Karnofsky performance status >/= 60.

5) Evidence of progressive neurologic signs or symptoms appropriate to the location of the radiation necrosis.

6) No prior bevacizumab therapy.

7) Patients are allowed to have received prior chemotherapy for their tumor. No limit on prior chemotherapies will be made. Patients who have been treated with tyrosine kinase inhibitors of VEGFR will be permitted. However, no concurrent chemotherapy or tyrosine kinase inhibitors of VEGFR will be allowed.

8) Routine laboratory studies with bilirubin </=1.5 x ULN, AST < 2.5 x ULN, creatinine <1.0 x ULN, granulocytes >1500, platelets> 75,000; Hb >/=9.0, diarrhea must be < grade 1.

9) If history of seizures, patients should be on anticonvulsant therapy. Patients can be on enzyme-inducing anticonvulsants if necessary; however, preference will be for enzyme-non-inducing anticonvulsants.

10) Patients can be on dexamethasone but must be on a stable dose for >/= 1 week prior to study enrollment and the onstudy MRI.

11) Age >/=18 years. Because no dosing or adverse event data are currently available on the use of bevacizumab in patients <18 years of age, children are excluded from this study but will be eligible for future pediatric single-agent trials, if applicable.

12) Ability to understand and the willingness to sign a written informed consent document.

13) Patients on full-dose anticoagulants (e.g., warfarin) with PT INR >1.5 are eligible provided that: 1) The patient has an in-range INR (usually between 2 and 3) on a stable dose of oral anticoagulant for 1 week or on a stable dose of low molecular weight heparin; 2) The patient has no active bleeding or pathological condition that carries a high risk of bleeding; 3) there is no evidence of serious or non-healing wound, ulcer or bone fracture.

Exclusion Criteria:

1) WHO grade 4 primary brain neoplasms such as glioblastoma and gliosarcoma

2) For head and neck cancer, patients with any of the following should also be excluded: 1) evidence of metastatic disease; 2) evidence of tumor invasion to major vessels (e.g. the carotid); 3) history of bleeding related to tumor or radiotherapy during or after completion of radiation.

3) Evidence of active CNS hemorrhage.

4) History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 28 days prior to study enrollment.

5) Invasive procedures defined as follows: 1) Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to Day 1 therapy; 2) Anticipation of need for major surgical procedures during the course of the study; 3) Core biopsy within 7 days prior to D1 therapy.

6) Patients with clinically significant cardiovascular disease are excluded: 1) Inadequately controlled HTN (SBP > 140 mmHg and/or DBP > 90 mmHg despite antihypertensive medication); 2) History of large vessel CVA within 6 months; 3) Myocardial infarction or unstable angina within 6 months; 4) New York heart association grade II or greater congestive heart failure; 5) Serious and inadequately controlled cardiac arrhythmia; 6) Significant vascular disease (e.g. aortic aneurysm, history of aortic dissection); 7) Clinically significant peripheral vascular disease.

7) Evidence of bleeding diathesis or coagulopathy.

8) Pregnant (positive pregnancy test) or nursing women. Angiogenesis is critical to fetal development and the inhibition of angiogenesis following administration of AVASTIN is likely to result in adverse effects on pregnancy. There are no adequate and well-controlled studies in pregnant women. Both fertile men and women must agree to use adequate contraceptive measures during study therapy and for at least 2 months after the completion of bevacizumab therapy.

9) Patients may not be receiving any other investigational agents.

Links

Registration Number: NCT00492089
Study Information on Clinical Trials Registry (clinicaltrials.gov)