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

Study 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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT00795665
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 University of California, Davis
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Robert T. O'Donnell, MD, PhD
Principal Investigator Affiliation University of California, Davis
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other, NIH, Industry
Overall Status Completed
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Glioma
Additional Details

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.

Arms & Interventions

Arms

Experimental: Bevacizumab and Carmustine

Interventions

Drug: - bevacizumab

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.

Drug: - carmustine

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Sacramento, California

Status

Address

University of California Davis Cancer Center

Sacramento, California, 95817

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