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A Phase I Dose Per Fraction Escalation Study of Hypofractionated Intensity-Modulated Radiation Therapy (Hypo-IMRT) Combining With Temozolomide (TMZ) Chemotherapy for Patients With Newly Diagnosed Glioblastoma Multiforme (GBM)

Phase 1
18 Years
Open (Enrolling)
Glioblastoma Multiforme

Thank you

Trial Information

A Phase I Dose Per Fraction Escalation Study of Hypofractionated Intensity-Modulated Radiation Therapy (Hypo-IMRT) Combining With Temozolomide (TMZ) Chemotherapy for Patients With Newly Diagnosed Glioblastoma Multiforme (GBM)

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 patients will receive higher doses per fraction of radiation while
keeping the total dose of radiation the same (60 Gy, Gy is a radiation unit). The radiation
dose per fraction will be increased and the numbers of radiation treatments will be
decreased until a fraction dose is reached at which there are unacceptable side effect
compared with possible benefit. Which group you are in will depend on what stage the study
has reached at the time you decide to participate.

This research is being done because with current standard radiation therapy (A total dose of
60 Gy given 2 Gy a day over 6 weeks.) the outcome is very poor. New and more effective
radiation therapy methods are desperately needed for the patients like you with GBM.

In this study, radiation therapy is given together with chemotherapy of Temozolomide.

This study is also designed to monitor the level of some of the known cytokines (specific
proteins in the blood) before and after radiation, and in meantime to screen unknown
proteins in patients' blood before and after radiation therapy. Hopefully, this will provide
us with some clues for future study of monitoring radiation damage, and possibly new
therapeutic approach for patients like you with GBM.

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. Patients with contraindications for
MRI scanning are ineligible for this study.

- 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 cannot be treated on any other clinical protocols within 30 days prior to
study entry or during participation in the study.

- 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.

- No active connective tissue disorders, such as active lupus or scleroderma.

- Radiation therapy and chemotherapy must start within 8 weeks of tumor resection or

Exclusion Criteria:

- 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)

- 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.

- concurrent active malignancy at other sites.

- frequent vomiting of medical condition which could interfere with oral medication
intake (e.g. partial bowel obstruction).

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To identify the maximum dose per fraction of IMRT a patient can tolerate while keeping the total radiation dose at 60 Gy, provided concurrently with daily oral temozolomide chemotherapy

Outcome Description:

To determine the frequency of patients developing >= grade 3 acute and delayed toxicities attributable to radiotherapy. Acute radiotherapy toxicities are defined as those toxicities which occur during and within 30 days from the completion of radiotherapy and delayed toxicity are those developed at least 30 days after the last dose of radiation.

Outcome Time Frame:

Up to 60 days

Safety Issue:


Principal Investigator

Changhu Chen, M.D

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Colorado, Denver


United States: Institutional Review Board

Study ID:



Start Date:

November 2005

Completion Date:

November 2014

Related Keywords:

  • Glioblastoma Multiforme
  • Glioblastoma Multiforme
  • Glioblastoma



University of Colorado Cancer Center Denver, Colorado  80262