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

• Status: Completed
• Trial end date: 2016-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Colorado, Denver
• Treatments: Dacarbazine; Temozolomide

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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).