Palliative 4pi Radiotherapy in Treating Patients With Recurrent Glioblastoma Multiforme

PRIMARY OBJECTIVES:

I. To determine the accuracy of dose delivery and patient comfort with treatment time.

II. To evaluate normal tissue dose volume statistics and compare to standard planning.

OUTLINE:

Patients undergo 4pi radiation simulation and planning followed by 5 to 10 daily fractions of
4pi palliative radiotherapy. If an acceptable plan cannot be achieved using 4pi planning,
then the patient will be treated with standard radiation therapy planning for palliative
re-irradiation.

After completion of study treatment, patients are followed up at 6 weeks.

Inclusion Criteria:

- Histologically confirmed primary glioblastoma multiforme (GBM)

- Patient must have previously undergone standard chemoradiation- 59.4 Gy (1.8
Gy/fraction) or 60 Gy (2.0 Gy/fraction) with concurrent and adjuvant Temodar
(temozolomide)

- Patient must be diagnosed with recurrent GBM either with biopsy or radiographically

- Karnofsky Performance Status (KPS) >= 70

- Ability to understand and willingness to sign a written informed consent

- If a woman is of childbearing potential, a negative serum pregnancy test must be
documented; women of childbearing potential must agree to use adequate contraception
(hormonal or barrier method of birth control; or abstinence) for duration of study
treatment and for up to 4 weeks following the study treatment

- For the purpose of this study, all women are considered to be of childbearing
potential unless they are post-menopausal at least 1 year since last menses),
biologically sterile, or surgically sterile (i.e. hysterectomy, bilateral
oophorectomy or tubal ligation)

Exclusion Criteria:

- Patients with active infection

- Patients with KPS < 70 and/or unable to tolerate potentially longer treatment times

- Refusal to sign informed consent

- Pregnant women, or women of childbearing potential who are sexually active and not
willing/able to use medically acceptable forms of contraception for the entire study
period and for up to 4 weeks after the study treatment

- Note: Concurrent and/or adjuvant chemotherapy does not make a patient ineligible;
participation in a concurrent treatment protocol does not make a patient ineligible