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Phase II Study of Bi-Weekly Temozolomide Plus Bevacizumab for Adult Patients With Recurrent Glioblastoma Multiforme


Phase 2
18 Years
83 Years
Open (Enrolling)
Both
Recurrent Glioblastoma Multiforme, Recurrent Gliosarcoma

Thank you

Trial Information

Phase II Study of Bi-Weekly Temozolomide Plus Bevacizumab for Adult Patients With Recurrent Glioblastoma Multiforme


This is a phase II study of the combination of Avastin and temozolomide for patients with
recurrent glioblastoma multiforme. Avastin is administered intravenously at a dose of 10
mg/kg on days 1 and 15 every 28 days and temozolomide is administered at a dose of 100 mg/m2
on days 1-5 and 15-19 every 28 days (one cycle). Patients will have a baseline MRI, an MRI
scan after the first cycle and every other cycle after that. If there is no evidence of
disease progression or unacceptable toxicity, patients will receive one year of therapy. If
there is evidence of added benefit (eg: tumor regression), patients can stay on treatment
longer than one year, per investigator discretion.


Inclusion Criteria:



Patients must have histologically confirmed diagnosis of a glioblastoma
multiforme/gliosarcoma and:

- Must have completed at least 2 cycles of adjuvant chemotherapy

- Age > 18 years

- Karnofsky > 60%

- Hematocrit > 29%, ANC > 1,500 cells/dl, platelets > 125,000 cells/dl

- Serum creatinine < 1.5 mg/dl, BUN < 25 mg/dl, serum SGOT and bilirubin < 1.5 times
upper limit of normal

- If on corticosteroids, must be on a stable dose for 1 week prior to entry; if
clinically possible, the dose should not be escalated over entry dose level

- Signed informed consent approved by the Institutional Review Board prior to study
entry

- If sexually active, will take contraceptive measures for the duration of the
treatments

Exclusion Criteria:

- Prior toxicity grade ≥ 3 with TMZ

- Prior treatment with bevacizumab

- Female patients who are pregnant or breast feeding, or adults of reproductive
potential not employing an effective method of birth control

- Concurrent severe and/or uncontrolled medical disease that could compromise
participation in the study

- Acute or chronic liver disease (i.e., hepatitis, cirrhosis)

- Confirmed diagnosis of HIV infection

- Have received investigational drugs less than 4 weeks prior to entry on this study or
who have not recovered from the toxic effects of such therapy

- Have received chemotherapy within 2 weeks prior (6 weeks for nitrosourea) to entry on
this study, or who have not recovered from the toxic effects of such therapy

- Have received biologic, immunotherapeutic or cytostatic agents within 1 week prior to
entry on this study or who have not recovered from the toxic effects of such therapy

- Less than 5 years free of another primary malignancy except: if the other primary
malignancy is not currently clinically significant

- Have received radiation therapy within 2 weeks prior to entry on this study or who
have not recovered from the toxic effects of such therapy.

- Surgical resection of brain tumor within 4 weeks prior to entry on this study or who
have not recovered from side effects of such therapy

- Have had any surgery other than resection of a brain tumor within 4 weeks prior to
entry on this study or who have not recovered from side effects of such therapy

- Unwilling to or unable to comply with the protocol

- Evidence of tumor progression within on immediate post radiation brain imaging

- Have not received at least 2 cycles of adjuvant chemotherapy

- Life expectancy of less than 12 weeks

- Current, recent (within 4 weeks of the first infusion of this study), or planned
participation in an experimental drug study

Bevacizumab-Specific Exclusions:

- 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 (see
Appendix E)

- History of myocardial infarction or unstable angina within 6 months

- History of stroke or transient ischemic attack within 6 months

- Significant vascular disease (e.g., aortic aneurysm, requiring surgical repair or
recent peripheral arterial thrombosis) within 6 months

- 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 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

- 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 greater than or equal to 1.0 at screening

- Known hypersensitivity to any component of bevacizumab

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

6-month progression-free survival.

Outcome Time Frame:

6 months

Safety Issue:

No

Principal Investigator

Michael A. Badurddoja, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Center for Neurosciences

Authority:

USA: Institutional Review Board

Study ID:

AVF4514s

NCT ID:

NCT00883298

Start Date:

April 2009

Completion Date:

June 2013

Related Keywords:

  • Recurrent Glioblastoma Multiforme
  • Recurrent Gliosarcoma
  • temozolomide
  • bevacizumab
  • Temodar
  • Avastin
  • glioblastoma multiforme
  • gliosarcoma
  • glioma
  • GBM
  • brain tumor
  • Glioblastoma
  • Gliosarcoma

Name

Location

Center for NeurosciencesTucson, Arizona  85718