Recruiting
Phase 2

Gliadel, Temozolomide, Bevacizumab

Sponsor:

Kentuckiana Cancer Institute

Code:

NCT00660621

Conditions

Glioma

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Temozolomide and Bevacizumab

Study Details

Brief summary:

To determine the safety and efficacy of surgical resection with Gliadel® 3.85% wafer implantation, followed by concomitant limited field radiation therapy and temozolomide, followed by dose dense temozolomide and bevacizumab in subjects undergoing initial surgery for newly-diagnosed high grade glioma.

Conditions

Glioma

Study ID

NCT00660621

Start date

Apr, 2008

Status verified date

Jan, 2010

Completion date

Dec, 2010

Anticipated

Primary completion date

Dec, 2010

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Subjects, men and women, must be between ages 18 and 75 years.
  • Subjects must have radiographic evidence on cranial magnetic resonance imaging (MRI) of a single, contrast-enhancing unilateral supratentorial cerebral tumor.
  • Surgery is recommended within 4 weeks of the baseline MRI scan.
  • Subjects must have a Karnofsky Performance Score of 60 or higher.
  • Subjects must have signed an Institutional Review Board (IRB)-approved informed consent prior to any non-standard of care study procedure or no later than the start of dose dense temozolomide and bevacizumab..
  • Subjects must have a pathological diagnosis of a high grade (IV) malignant glioma.
  • Subjects, both men and women, must be willing to avoid pregnancy for up to 2 years after wafer implantation surgery and be counseled regarding the unknown, and potentially harmful, risks to the embryo or fetus from participation in this study.

Exclusion Criteria:

  • Subjects who have had prior cytoreductive surgery for high-grade glioma. Subjects who have had a diagnostic stereotactic biopsy are eligible.
  • Subjects with more than one focus of tumor or tumor crossing the midline as assessed by coronal cranial MRI scan.
  • Concomitant significant life-threatening disease from which the subject could reasonably be expected to die within the first 12 months of the study.
  • Known hypersensitivity reactions to temozolomide, nitrosoureas or any other components of the Gliadel® wafer.
  • Prior CNS radiotherapy.
  • Subjects who have received any prior chemotherapy for this malignant glioma prior to the baseline evaluation or subjects who are currently being treated with chemotherapeutic agents.
  • Subjects with fewer than 100,000 platelets per mm3 or fewer than 3.500 leukocytes per mm3.
  • Liver function tests greater than or equal to 2.5 times the upper limit of normal (transaminases (SGOT, SGPT), total bilirubin, alkaline phosphatase).
  • Serum creatinine equal to or greater than 1.5 times the upper limit of normal, blood urea nitrogen (BUN) equal to or greater than 2.5 times the upper limit of normal.
  • Pregnancy, or lactating females or females of childbearing potential not using adequate contraception.
  • Participation in any other investigational protocol in the prior twelve months for any type of malignancy.
  • Psychological, familial, sociological or geographical conditions which do not permit adequate medical follow-up and compliance with the study protocol.
  • Inadequately controlled hypertension (blood pressure systolic > 150 mmHg or diastolic > 100 mmHg).
  • Unstable angina or history of myocardial infarction within six months prior to enrollment.
  • Evidence of bleeding, diathesis, or coagulopathy. Chronic full-dose anticoagulation with warfarin is not permitted though subjects may be on low molecular weight heparin or fondaparinux.
  • Serious non-healing wound, ulcer, or bone fracture.

Study Design

Enrollment

40 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Interventions

Temozolomide and Bevacizumab

Between 14 and 28 days after surgery, all subjects will begin a standard course of post-operative limited field radiation therapy to the tumor site and a surrounding margin with concomitant temozolomide at a daily dose of 75 mg/m2 (7 days/week).

No later than 45 days after date of completion of radiation therapy, all subjects will begin dose dense temozolomide at dose of 150 mg/m2 on Days 1-7 and 15-21 of a 28 day cycle with concomitant bevacizumab 10mg/kg administered intravenously every other week.

Primary outcome measure

  • Safety and efficacy of concomitant limited field radiation therapy and temozolomide, followed by dose dense temozolomide and bevacizumab in subjects undergoing initial surgery for newly-diagnosed high grade glioma. [ Time Frame: First 5 subjects after 6 months. ]

Central Contacts and Locations

Central contacts

Leslie Haysley

502-561-8200lhaysley@kci.us

Julie Kauzlarich

502-561-8200jkauzlarich@kci.us

Locations

Kentuckiana Cancer Institute

Recruiting

Louisville, Kentucky, United States, 40202

Contacts

Roxann R. Smalley, JD

502-561-8200rsmalley@kci.us

Principal Investigator:

Renato V. LaRocca, MD

More Information

Sponsor

Kentuckiana Cancer Institute

Last update posted

Jan 20, 2010

Last verified

Jan, 2010

Keywords

  • High Grade
  • Malignant
  • GBM

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Kentuckiana Cancer Institute on 2010-01-20.