Clinical Trial Details
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[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT01067469 : Standard Dose Bevacizumab Versus Low Dose Bevacizumab Plus Lomustine (CCNU) for Recurrent Glioblastoma Multiforme (GBM)
PhasePhase 2
AgesMin: 18 Years Max: N/A
Eligibility
Inclusion Criteria:

1. Signed Informed Consent Form

2. Age >/= 18 years

3. Histologically confirmed glioblastoma in first, second or third relapse. A pathology
report constitutes adequate documentation of histology for study inclusion. Subjects
with an initial diagnosis of a lower grade glioma are eligible if a subsequent biopsy
is determined to be glioblastoma. The amount of prior systemic therapy for this
population is, nevertheless, restricted to three regimens, with one including
temozolomide.

4. Radiographic demonstration of disease progression following prior therapy

5. Bi-dimensionally measurable disease with a minimum measurement of 1 cm (10 mm) in one
diameter on MRI performed within 14 days prior to registration (Day 1). Baseline MRIs
for subjects who underwent salvage surgery after first or second relapse must be
obtained >/= 4 weeks after the procedure. If receiving corticosteroids, subjects must
be on a stable or decreasing dose of corticosteroids for >/= 5 days prior to baseline
MRI.

6. Patients having undergone recent resection of recurrent or progressive tumor will be
eligible as long as all of the following conditions apply: 1) They have recovered
from the effects of surgery. 2) Evaluable or measurable disease following resection
of recurrent tumor is not mandated for eligibility into the study. 3) To best assess
the extent of residual measurable disease post-operatively, a MRI should be done no
later than 96 hours in the immediate post-operative period or 4-6 weeks
post-operatively. .

7. An interval of >/= 4 weeks since surgical resection is required prior to starting
protocol therapy.

8. Prior standard radiation for glioblastoma

9. Prior chemotherapy: All first-relapse subjects must have received temozolomide. All
second- and third-relapse subjects must have received temozolomide. Patients may not
have received prior nitrosoureas.

10. Recovery from the effects of prior therapy, including the following: Four weeks from
cytotoxic agents (3 weeks from procarbazine, 2 weeks from vincristine); Four weeks
from any investigational agent; One week from non-cytotoxic agents(eg accutane,
thalidomide); Eight weeks from radiotherapy to minimize the potential for MRI changes
related to radiation necrosis that might be misdiagnosed as progression of disease,
or 4 weeks if a new lesion, relative to the pre-radiation MRI, develops that is
outside the primary radiation field; Patients may have had gliadel wafers during
their original surgery but they must be >/= 9 months post their original surgery
date.

11. Prior therapy with gamma knife or other focal high-dose radiation is allowed, but the
subject must have subsequent histologic documentation of recurrence or PET or MR
Spectroscopic documentation of tumor, unless the recurrence is a new lesion outside
the irradiated field

12. Patients must have adequate bone marrow function (WBC >/= 3,000/µl, ANC >/=
1,500/mm^3, platelet count of >/= 100,000/mm^3, and hemoglobin >/= 10 gm/dl),
adequate liver function (SGPT < 3 times normal and alkaline phosphatase < 2 times
normal, bilirubin <1.5 mg/dl), adequate renal function (creatinine creatinine clearance >/= 60 cc/min/1.73 m^2) and a urine protein:creatinine ratio of
registration. Eligibility level for hemoglobin may be reached by transfusion.

13. Patients must have a Karnofsky performance status (KPS) equal or greater than 60

14. Use of an effective means of contraception in males and in females of childbearing
potential. Women of childbearing potential must have a negative ?-HCG pregnancy test
documented within 14 days prior to registration. Should a woman become pregnant or
suspect she is pregnant while participating in this study, she should inform her
treating physician immediately.

15. Ability to comply with study and follow-up procedures

16. Patients receiving treatment with other antiepileptic medications will not be
excluded. Patients should preferably be treated with non-enzyme inducing
anti-epileptic medications to avoid any potential interactions with lomustine.
However, the use of non-enzyme inducing anti-epileptic medications is not mandatory.
If enzyme-inducing antiepileptic drugs are used, monitoring of drug levels should be
considered, as considered clinically appropriate by the treating physician.

17. Patients on the following medications will be included:
Anticoagulants/Anti-platelets: Patients on stable dose anticoagulants (e.g. warfarin,
low molecular-weight heparin) and in-range INR (2-3) are eligible. Patients are
allowed to take aspirin, clopidogrel, ticlopidine, Aggrenox, ibuprofen and other
NSAIDS.

18. Patients must be willing to forego other cytotoxic and non-cytotoxic drug therapy
against the tumor while enrolled in the study.

19. This study was designed to include women and minorities, but was not designed to
measure differences of intervention effects. Males and females will be recruited with
no preference to gender. No exclusion to this study will be based on race. Minorities
will actively be recruited to participate.

Exclusion Criteria:

1. Prior treatment with anti-angiogenesis (eg bevacizumab, sorafenib, sunitinib) agent
or nitrosurea (eg. lomustine, carmustine, nimustine).

2. Prior treatment with polifeprosan 20 with carmustine wafer except for the patients
with gliadel wafers >/= 9 months post their original surgery date.

3. Patients must not have received any investigational agents within 28 days prior to
commencing study treatment.

4. Prior intracerebral agents

5. Need for urgent palliative intervention for primary disease (e.g., impending
herniation)

6. Evidence of recent hemorrhage on baseline MRI of the brain with the following
exceptions: (1) Presence of hemosiderin (2) Resolving hemorrhagic changes related to
surgery (3) Presence of punctate hemorrhage in the tumor

7. Blood pressure of > 140 mmHg systolic and > 90 mmHg diastolic

8. History of hypertensive encephalopathy

9. New York Heart Association (NYHA) Grade II or greater chronic heart failure(CHF)

10. History of myocardial infarction or unstable angina within 6 months prior to Day 1

11. History of stroke or transient ischemic attack within 6 months prior to study
enrollment

12. Significant vascular disease (e.g., aortic aneurysm, aortic dissection) or recent
peripheral arterial thrombosis within 6 months prior to Day 1

13. Evidence of bleeding diathesis or coagulopathy or INR >1.5 unless on a stable dose of
anticoagulation therapy. History of significant bleeding disorder unrelated to
cancer, including: (1) Diagnosed congenital bleeding disorders (e.g., von
Willebrand's disease) (2) Diagnosed acquired bleeding disorder within one year (e.g.,
acquired anti-factor VIII antibodies) (3) Ongoing or recent ( significant gastrointestinal bleeding

14. History of abdominal fistula, gastrointestinal perforation, or intra-abdominal
abscess within 6 months prior to Day 1

15. History of intracerebral abscess within 6 months prior to Day 1

16. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days
prior to Day 1, anticipation of need for major surgical procedure during the course
of the study

17. Minor surgical procedures (excluding placement of a vascular access device),
stereotactic biopsy, fine needle aspirations, or core biopsies within 7 days prior to
Day 1

18. Serious non-healing wound, ulcer, or bone fracture

19. Pregnancy (positive pregnancy test) or lactation

20. Known hypersensitivity to any component of bevacizumab

21. History of any other malignancy (except non-melanoma skin cancer or carcinoma in situ
of the cervix), unless in complete remission and off of all therapy for that disease
for a minimum of 3 years are ineligible

22. Pregnant or nursing females

23. Unstable systemic disease, including active infection, uncontrolled hypertension, or
serious cardiac arrhythmia requiring medication

24. Subjects unable to undergo an MRI with contrast

25. Patients with a known allergy to bevacizumab, or a known allergy to nitrosoureas (eg.
lomustine, carmustine, nimustine) will be excluded

26. Patient must be able to tolerate the procedures required in this study including
periodic blood sampling, study related assessments, and management at the treating
institution for the duration of the study. Inability to comply with protocol or study
procedures (for example, an inability to swallow tablets) will be an exclusion
criteria.
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT01067469      |      Link to official Clinicaltrials.gov listing
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