Expired Study
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Sacramento, California 95817


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.


Study summary:

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.


Criteria:

Inclusion Criteria: - Histologically confirmed GBM, anaplastic astrocytoma, anaplastic oligoastrocytoma or anaplastic oligodendroglioma. - Disease progression (confirmed by MRI, PET or both) after radiation therapy - At least 28 days have elapsed since chemotherapy, major surgery or radiation therapy. - No other malignancy within 3 years except for non-melanomatous skin cancer or in situ cervical cancer. - Karnofsky performance score at least 70 - Platelet count ≥ 130/mm3. - Absolute neutrophil count ≥ 1500/mm3 - Calculated creatinine clearance greater than 45 mg/dl - AST < 2 times the upper limit of normal - Bilirubin < 1.5 times the upper limit of normal - Ability to give signed informed consent - Patients must be 18 years of age or older. Exclusion Criteria: - Prior intravenous or oral nitrosoureas (BCNU, CCNU) or prior VEGF targeted therapy including bevacizumab. No more than two prior chemotherapy regimens are allowed. Prior or current steroid use is allowed. - Evidence of CNS hemorrhage - Requirement for therapeutic anticoagulation - Any grade 3 or greater hemorrhage within the previous 28 days - Active inflammatory bowel disease - Inadequately controlled hypertension - Any prior history of hypertensive crisis or hypertensive encephalopathy - New York Heart Association Grade II or greater congestive heart failure - History of myocardial infarction or unstable angina within 6 months prior to study enrollment - History of stroke or transient ischemic attack within 6 months prior to study enrollment - Significant vascular disease - Symptomatic peripheral vascular disease - Evidence of bleeding diathesis or coagulopathy - Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study enrollment 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 study enrollment - History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to study enrollment - Serious, non-healing wound, ulcer, or bone fracture - Proteinuria at screening - Pregnant (or lactating). Use of effective means of contraception in subjects of child-bearing potential - Prior organ transplantation - Known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies - Known acquired immune deficiency syndrome (AIDS) or HIV positive status


Study is Available At:


Original ID:

CDR0000626157


NCT ID:

NCT00795665


Secondary ID:

P30CA093373


Study Acronym:

UCDCC#208


Brief Title:

Bevacizumab and Carmustine in Treating Patients With Relapsed or Progressive High-Grade Glioma


Official Title:

Phase II Study of Bevacizumab (Avastin) and BCNU for Treatment of Relapsed, High Grade Gliomas


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of California, Davis


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Intervention Model: Single Group Assignment, Maski


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

7


Enrollment Type:

Actual


Overall Contact Information

Official Name:Robert T. O'Donnell, MD, PhD
Principal Investigator
University of California, Davis

Study Dates

Start Date:June 2008
Completion Date:December 2015
Completion Type:Actual
Primary Completion Date:December 2015
Primary Completion Type:Actual
Verification Date:January 2016
Last Changed Date:January 4, 2016
First Received Date:November 20, 2008

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Overall survival
Time Frame:Time from first day of treatment to time of death due to any cause.
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Safety and Toxicity
Time Frame:One year
Safety Issues:True
Description:Subjects will be assessed clinically for toxicity prior to, during, and after each infusion. NCI CTCAE 3.0 Common Terminology Criteria (CTC) for Adverse Events for toxicity and Adverse Event Reporting will be utilized.
Outcome Type:Secondary Outcome
Measure:Differentiate a radiographic response due to tumor shrinkage from a radiographic response due to decreased vasogenic edema
Time Frame:One year
Safety Issues:False
Description:Measurements made by novel brain imaging
Outcome Type:Secondary Outcome
Measure:Radiographic response to therapy
Time Frame:One year
Safety Issues:False
Description:Response measured using MRI and PET with image fusion
Outcome Type:Primary Outcome
Measure:Progression-free survival
Time Frame:Time from first day of treatment to the first observation of disease progression or death due to any
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:bevacizumab
Description:Bevacizumab (10 mg/kg) will be given intravenously every other week starting one week before the first dose of BCNU. Treatment with both BCNU and bevacizumab for 6-months, after which the participant may continue to receive bevacizumab every 2 weeks for a maximum of one year and three additional cycles of BCNU.
Arm Name:Bevacizumab and Carmustine
Other Name:Avastin
Intervention Type:Drug
Name:carmustine
Description:BCNU (200 mg/m2), will be given over 4 hours as a continuous intravenous infusion every 8 weeks. Treatment with both BCNU and bevacizumab for 6-months, after which the participant may continue to receive bevacizumab every 2 weeks for a maximum of one year and three additional cycles of BCNU.
Arm Name:Bevacizumab and Carmustine
Other Name:BCNU

Study Arms

Study Arm Type:Experimental
Arm Name:Bevacizumab and Carmustine

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of California, Davis
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Cancer Institute (NCI)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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