Status:
COMPLETED
A Dose Per Fraction Escalation Trial of Hypofractionated IMRT With Temozolomide for Newly Diagnosed Glioblastoma
Lead Sponsor:
University of Colorado, Denver
Conditions:
Glioblastoma Multiforme
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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.
Detailed Description
Hypo-IMRT is given in fewer treatments than conventional radiation therapy. This will be a dose per fraction escalation study. A dose per fraction escalation study means that successive groups of pati...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2016
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT00792012
Start Date
November 1 2005
End Date
July 1 2016
Last Update
March 27 2017
Active Locations (1)
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1
University of Colorado Cancer Center
Aurora, Colorado, United States, 80045