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Gliadel, XRT, Temodar, Avastin Followed by Avastin, Temodar for Newly Diagnosed Glioblastoma Multiforme (GBM)

Information source: Duke University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Glioblastoma Multiforme; Gliosarcoma

Intervention: Gliadel (Drug); Radiation Therapy (Radiation); Avastin (Drug); Temodar (Drug)

Phase: Phase 2

Status: Active, not recruiting

Sponsored by: Duke University

Official(s) and/or principal investigator(s):
Annick Desjardins, MD, FRCPC, Principal Investigator, Affiliation: Duke University

Summary

The purpose of this study is to determine the safety and effectiveness of Gliadel wafers at the time of surgery, followed by the combination of radiation, Temodar, and Avastin, and then the combination of Avastin and Temodar, after radiation is complete, on malignant brain tumors. About six weeks after surgery, subjects will begin standard radiation therapy, a fixed dose of Avastin every 2 weeks, and daily Temodar for the six and a half weeks of radiation. Beginning 2-3 weeks after the last radiation therapy, subjects will be given the same fixed dose of Avastin intravenously (through the vein) every 14 days. They will also be given a higher dose of oral Temodar to take daily the first 5 days of each 28-day study cycle.

Clinical Details

Official title: Phase II Trial for Patients With Newly Diagnosed Glioblastoma Multiforme (GBM) Treated With Gliadel Followed by Concurrent Radiation Therapy, Temodar and Avastin, Then Followed by Avastin and Temodar Post-Radiation

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: 21-month Overall Survival

Secondary outcome:

Median Overall Survival

Median Progression-free Survival

Unacceptable Toxicity Related to the Treatment Regimen

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Patients must have a MRI consistent with a WHO grade IV primary malignant glioma

(glioblastoma multiforme or gliosarcoma), and be candidates for surgical resection with Gliadel wafer placement. Patients have to be within 6 weeks of the last major surgical procedure.

- Age ≥ 18 years

- Candidates for Gliadel

- If a prior procedure was done, an interval of at least 2 weeks and not > 8 weeks

between prior major surgical procedure and study enrollment

- No prior radiotherapy or chemotherapy for a brain tumor

- Karnofsky > 60%

- Hemoglobin ≥ 9. 0 g/dl, ANC ≥ 1,500 cells/microliters, platelets ≥ 125,000

cells/microliters

- Serum creatinine ≤ 1. 5 mg/dl, serum SGOT and bilirubin ≤ 1. 5 times upper limit of

normal.

- Signed informed consent approved by the Institutional Review Board

- If sexually active, patients must agree to use appropriate contraceptive measures for

the duration of the study and for 6 months afterwards as stated in the informed consent. Exclusion Criteria:

- Pregnancy or breast feeding.

- Co-medication that may interfere with study results; e. g. immuno-suppressive agents

other than corticosteroids.

- Active infection requiring IV antibiotics.

- Prior treatment with radiotherapy or chemotherapy for a brain tumor, irrespective of

the grade of the tumor.

- Evidence of > grade 1 CNS hemorrhage on baseline MRI or CT scan.

- Prior treatment with Avastin for any condition

- Prior, unrelated malignancy requiring active treatment with the exception cervical

carcinoma in situ and adequately treated basal cell or squamous cell carcinoma of the skin Avastin-Specific Exclusion Criteria:

- Inadequately controlled hypertension (defined as systolic blood pressure >150 and/or

diastolic blood pressure > 100 mmHg)

- Prior history of hypertensive crisis or hypertensive encephalopathy

- New York Heart Association (NYHA) 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 (e. g., aortic aneurysm, requiring surgical repair or

recent peripheral arterial thrombosis) within 6 months prior to study enrollment

- History of hemoptysis (≥ ½ teaspoon of bright red blood per episode) within 1 month

prior to study enrollment

- Evidence of bleeding diathesis or coagulopathy (in the absence of therapeutic

anticoagulation)

- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days

prior to the first Avastin infusion 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 within 6 months prior to

study enrollment

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

- Proteinuria at screening as demonstrated by urine dipstick for proteinuria ≥ 2+

(patients discovered to have ≥2+ proteinuria on dipstick urinalysis at baseline should undergo a 24-hour urine collection and must demonstrate ≤ 1g of protein in 24 hours to be eligible).

- Known hypersensitivity to any component of Avastin

- Pregnant (positive pregnancy test) or lactation. Use of effective means of

contraception (men and women) in subjects of child-bearing potential

Locations and Contacts

The Preston Robert Tisch Brain Tumor Center, Durham, North Carolina 27710, United States
Additional Information

The Preston Robert Tisch Cancer Center

Starting date: April 2011
Last updated: June 8, 2015

Page last updated: August 23, 2015

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