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Bevacizumab and Carmustine in Treating Patients With Relapsed or Progressive High-Grade Glioma
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), December 2008
Sponsors and Collaborators: University of California, Davis
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00795665
  Purpose

RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Drugs used in chemotherapy, such as carmustine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving bevacizumab together with carmustine may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving bevacizumab together with carmustine works in treating patients with relapsed or progressive high-grade glioma.


Condition Intervention Phase
Brain and Central Nervous System Tumors
Drug: bevacizumab
Drug: carmustine
Phase II

MedlinePlus related topics: Cancer
Drug Information available for: Carmustine Bevacizumab
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: Phase II Study of Bevacizumab (Avastin) and BCNU for Treatment of Relapsed, High Grade Gliomas

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Progression-free survival [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
  • Response rate [ Designated as safety issue: No ]
  • Time to disease progression [ Designated as safety issue: No ]
  • Safety and toxicity as measured by NCI CTCAE v3.0 criteria [ Designated as safety issue: Yes ]

Estimated Enrollment: 20
Study Start Date: June 2008
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • To determine the 6-month progression-free survival of patients with relapsed or progressive high-grade gliomas treated with bevacizumab and carmustine.

Secondary

  • To evaluate the radiographic response to this regimen as measured by MRI and PET scan with image fusion.
  • To utilize novel brain imaging to differentiate between a radiographic response due to tumor shrinkage and a radiographic response due to decreased vasogenic edema.
  • To evaluate the safety and toxicity of this regimen in these patients.
  • To evaluate the overall survival of these patients.

OUTLINE: Patients receive bevacizumab IV on days -7, 8, 22, 36, and 50 of course 1 and on days 8, 22, 36, and 50 of all subsequent courses. Patients also receive carmustine IV over 4 hours on day 1. Treatment repeats every 56 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

After completion of study therapy, patients are followed every 3 months.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed diagnosis of one of the following:

    • Glioblastoma multiforme
    • Anaplastic astrocytoma
    • Anaplastic oligoastrocytoma
    • Anaplastic oligodendroglioma
  • Disease progression (confirmed by MRI and/or PET scan) after radiotherapy

PATIENT CHARACTERISTICS:

  • Karnofsky performance status 70-100%
  • Platelet count ≥ 130,000/mm^3
  • ANC ≥ 1,500/mm^3
  • Creatinine clearance > 45 mg/dL
  • AST < 2 times upper limit of normal (ULN)
  • Bilirubin < 1.5 times ULN
  • Urine protein:creatinine ratio < 1.0 OR proteinuria < 2+ by urine dipstick

    • Patients with proteinuria ≥ 2+ by urine dipstick must demonstrate ≤ 1 g of protein by 24-hour urine collection
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No inadequately controlled hypertension (i.e., systolic BP > 150 mm Hg and/or diastolic BP > 100 mm Hg despite antihypertensive medications)
  • No history of hypertensive crisis or hypertensive encephalopathy
  • No NYHA class II-IV congestive heart failure
  • No myocardial infarction, unstable angina, stroke, or transient ischemic attack within the past 6 months
  • No significant vascular disease (e.g., aortic aneurysm or aortic dissection)
  • No symptomatic peripheral vascular disease
  • No evidence of bleeding diathesis or coagulopathy
  • No evidence of CNS hemorrhage
  • No hemorrhage ≥ grade 3 within the past 28 days
  • No significant traumatic injury within the past 28 days
  • No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months
  • No active inflammatory bowel disease
  • No serious non-healing wound, ulcer, or bone fracture
  • No known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies
  • No known AIDS or HIV positivity
  • No other malignancy within the past 3 years except for non-melanomatous skin cancer or in situ cervical cancer

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No prior IV or oral nitrosoureas (e.g., carmustine or lomustine)
  • No prior VEGF-targeted therapy, including bevacizumab
  • No prior organ transplant
  • No more than 2 prior chemotherapy regimens
  • Prior or concurrent steroids allowed
  • At least 28 days since prior chemotherapy or radiotherapy
  • At least 28 days since prior major surgery or open biopsy
  • At least 7 days since prior core biopsy or other minor surgery, except for placement of a vascular access device
  • No concurrent major surgery
  • No concurrent therapeutic anticoagulation
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00795665

Locations
United States, California
University of California Davis Cancer Center Recruiting
Sacramento, California, United States, 95817
Contact: Clinical Trials Office - University of California Davis Cancer     916-734-3089        
Sponsors and Collaborators
University of California, Davis
Investigators
Principal Investigator: Robert T. O'Donnell, MD, PhD University of California, Davis
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Responsible Party: University of California Davis Cancer Center ( Robert T. O'Donnell )
Study ID Numbers: CDR0000626157, UCD-208, UCDCC-208, 200715706-2, GENENTECH-UCD-208
Study First Received: November 20, 2008
Last Updated: December 23, 2008
ClinicalTrials.gov Identifier: NCT00795665  
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
adult anaplastic astrocytoma
adult glioblastoma
adult gliosarcoma
adult giant cell glioblastoma
adult anaplastic oligodendroglioma
adult mixed glioma
recurrent adult brain tumor

Study placed in the following topic categories:
Glioblastoma
Astrocytoma
Carmustine
Bevacizumab
Central Nervous System Neoplasms
Recurrence
Brain Neoplasms
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma
Oligodendroglioma
Glioma
Gliosarcoma
Nervous System Neoplasms
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Neoplasms, Nerve Tissue
Nervous System Diseases
Angiogenesis Inhibitors
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Therapeutic Uses
Growth Inhibitors
Angiogenesis Modulating Agents
Antineoplastic Agents, Alkylating
Neoplasms, Neuroepithelial
Alkylating Agents

ClinicalTrials.gov processed this record on January 14, 2009