A Dose Per Fraction Escalation Trial of Hypofractionated IMRT With Temozolomide for Newly Diagnosed Glioblastoma

Completed · Phase 1

Conditions studied: Glioblastoma Multiforme

In brief

The purpose of the study is to find out the highest dose per fraction of hypofractionated Intensity-Modulated Radiation Therapy (Hypo-IMRT) that can be safely given with temozolomide chemotherapy.

Key facts

Study ID

NCT00792012

Run by

University of Colorado, Denver

People needed

37

Starts

2005-11-01

Expected to finish

2016-07-01

Last updated by the study team

2017-03-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histopathologically confirmed WHO grade IV astrocytoma (GBM), tumor can be supra- or infra-tentorial in location but not located in the brain stem.
• Solitary or multifocal tumor.
• Tumor can be biopsied or resected, either totally or sub-totally.
• A pre-radiation therapy brain MRI is mandatory.
• Surgical cavity or surgical cavity + T1 enhancing residual tumor ≤ 6 cm in the largest diameter on the pre-radiation therapy MRI. In the case of multifocal tumor, the combined largest diameter of T1 enhancing tumor + surgical cavity ≤ 6 cm.
• Placement of bis-chloronitrosourea (BCNU) wafers at the time of surgery is allowed.
• Age > 18 years at time of registration.
• Estimated survival of at least 3 months.
• Zubrod Performance Scale of 0-2 (Karnofsky performance scale ≥ 60).
• Hgb > 9 gm; absolute neutrophil count (ANC) > 1500/ul; platelets > 100,000; Creatinine < 1.5 times the upper limit of laboratory normal value; Bilirubin < 2 times the upper limit of laboratory normal value; serum glutamate pyruvate transaminase (SGPT) or serum glutamate oxaloacetate transaminase (SGOT) < 3 times the upper limit of laboratory normal value.
• Patients must sign study-specific informed consent form prior to registration.
• Men and women and members of all ethnic groups are eligible for this trial.
• Radiation therapy and chemotherapy must start within 8 weeks of tumor resection or biopsy

You may not qualify if…

• Patients with contraindications for MRI scanning.
• Prior temozolomide chemotherapy.
• Prior brain irradiation.
• Evidence of severe or uncontrolled psychiatric or systemic disease (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal disease) that would interfere with study protocol as judged by the investigator.
• Acquired Immune Deficiency (HIV (+)/AIDS)
• Patients being treated on any other clinical protocols within 30 days prior to study entry or during participation in the study.
• Pregnant women or breast feeding women. Women of childbearing potential must practice medically approved contraceptive precautions. Men should be counseled and agreeable to follow acceptable birth control methods.
• Active connective tissue disorders, such as active lupus or scleroderma.
• Concurrent active malignancy at other sites.
• Frequent vomiting of medical condition which could interfere with oral medication intake (e.g. partial bowel obstruction).

Where it is running

• University of Colorado Cancer Center — Aurora, Colorado, United States

Full record on ClinicalTrials.gov

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