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Phase III Double-Blind Placebo-Controlled Trial of Conventional Concurrent Chemoradiation and Adjuvant Temozolomide Plus Bevacizumab Versus Conventional Concurrent Chemoradiation and Adjuvant Temozolo

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Trial Conditions
  • Brain and Central Nervous System Tumors
What is the purpose of this trial?

RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. 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. It is not yet known whether temozolomide and radiation therapy are more effective when given together with or without bevacizumab in treating glioblastoma or (gliosarcoma. PURPOSE: This randomized phase III trial is studying temozolomide and radiation therapy to compare how well they work when given together with or without bevacizumab in treating patients with newly diagnosed glioblastoma. (gliosarcoma closed to accrual as of 07-13-10).

Date & Status

Active, not recruiting

Who can Participate?

Eligibility

Ages:
18 and older

Gender:
Both

Eligibility

DISEASE CHARACTERISTICS:

- Histologically confirmed glioblastoma (gliosarcoma closed to accrual as of 07-13-10)

- WHO grade IV disease

- Tumor must have a supratentorial component

- Has undergone partial or complete surgical resection of tumor within the past 3-5
weeks

- Diagnosis must be made by surgical excision (not by stereotactic biopsy)

- No significant postoperative hemorrhage, defined as > 1 cm diameter of blood in
the tumor cavity by MRI or CT scan

- Has ≥ 1 block of tumor tissue of sufficient size available for analysis of MGMT
status and determination of molecular profile

- At least 1 cm³ of tissue composed primarily of tumor must be present

- No CUSA (Cavitron ultrasonic aspirator)-derived material

- No recurrent or multifocal malignant glioma

- No metastases detected below the tentorium or beyond the cranial vault

PATIENT CHARACTERISTICS:

- Karnofsky performance status 70-100%

- Absolute neutrophil count ≥ 1,800/mm³

- Platelet count ≥ 100,000/mm³

- Hemoglobin ≥ 10.0 g/dL (transfusion or other intervention allowed)

- ALT and AST ≤ 3 times normal

- Bilirubin ≤ 2.0 mg/dL

- PT/INR < 1.4 (for patients not on warfarin)

- Creatinine ≤ 1.7 mg/dL

- Urine protein:creatinine ratio < 0.5 OR 24-hour urine protein < 1,000 mg

- BUN ≤ 30 mg/dL

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for ≥ 6 months after
completion of study treatment

- Systolic blood pressure (BP) ≤ 160 mm Hg or diastolic BP ≤ 90 mm Hg

- No evidence of acute cardiac ischemia by electrocardiogram

- No other invasive malignancy within the past 3 years, except for nonmelanomatous skin
cancer or carcinoma in situ of the breast, oral cavity, or cervix

- No severe, active comorbidity, including any of the following:

- Unstable angina and/or congestive heart failure within the past 6 months

- Transmural myocardial infarction within the past 6 months

- Evidence of recent myocardial infarction or ischemia as indicated by ST
elevations of ≥ 2 mm by EKG

- New York Heart Association class II-IV congestive heart failure requiring
hospitalization within the past 12 months

- Stroke, cerebral vascular accident, or transient ischemic attack within the past
6 months

- Serious, inadequately controlled cardiac arrhythmia

- Significant vascular disease (e.g., aortic aneurysm or history of aortic
dissection) or clinically significant peripheral vascular disease

- Evidence of bleeding diathesis or coagulopathy

- Serious or non-healing wound, ulcer, or bone fracture

- Abdominal fistula, gastrointestinal perforation, intra-abdominal abscess, or
significant traumatic injury within the past 28 days

- Acute bacterial or fungal infection requiring IV antibiotics

- Chronic obstructive pulmonary disease exacerbation or other respiratory illness
requiring hospitalization or precluding study therapy

- Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects

- AIDS based on current CDC definition

- Active connective tissue disorders (e.g., lupus or scleroderma) that, in the
opinion of the treating physician, may place the patient at high risk for
radiation toxicity

- Any other major medical illness or psychiatric impairment that, in the opinion
of the investigator, would preclude study drug administration or completion of
study therapy

PRIOR CONCURRENT THERAPY:

- Recovered from prior surgery

- No prior chemotherapy or radiosensitizers for cancer of the head and neck region

- Prior chemotherapy for a different cancer is allowed

- No prior temozolomide or bevacizumab

- No prior Gliadel wafers or any other intratumoral or intracavitary treatment

- No prior radiotherapy to the head and neck (except for T1 glottic cancer) resulting
in overlap of radiotherapy fields

- More than 28 days since prior major surgical procedure or open biopsy other than
craniotomy for tumor resection

- More than 30 days since prior and no concurrent treatment on another therapeutic
clinical trial

- No concurrent growth factors to induce elevations in neutrophil count for the
purposes of administration of temozolomide on the scheduled dosing interval; to allow
treatment with temozolomide at a higher dose; or to avoid interruption of the
treatment during concurrent radiotherapy

- No concurrent erythropoietin

- No concurrent tumor debulking surgery, other chemotherapy, immunotherapy, biologic
therapy, or additional stereotactic boost radiotherapy

- No other concurrent investigational drugs during the "blinded phase" of the study

- Concurrent full-dose anticoagulants (e.g., warfarin or low molecular weight heparin)
allowed provided both of the following criteria are met:

- No active bleeding or pathological condition that carries a high risk of
bleeding (e.g., tumor involving major vessels or known varices)

- In-range INR (between 2 and 3) on a stable dose of oral anticoagulant or on a
stable dose of low molecular weight heparin

Gender: Both
Steward Physician(s)
  • Mark R. Gilbert, MD
Facilities
  • Saint Anne's Hospital - Active, not recruiting
Trial Interventions
Biological
  • bevacizumab
Drug
  • temozolomide
Other
  • placebo
Physician Researcher

Investigator Name:

  • Mark R. Gilbert, MD

Other Information

Sponsor: Radiation Therapy Oncology Group
Phase: Phase 3
Trial ID: NCT00884741
Volunteers:  Not Accepting Healthy Volunteers

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