MRSI Guided Dose Escalated Radiation in Glioblastoma

Conditions:Brain Cancer
Therapuetic Areas:Oncology
Age Range:18 - Any
Start Date:March 2015
Contact:Fazilat Ishkanian, MD, PhD

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Phase II Study of Dose Escalated, Targeted Radiation Therapy Using 3D Magnetic Resonance Spectroscopy Imaging (MRSI) in Newly Diagnosed Glioblastoma

In summary, the overall prognosis of glioblastoma (GBM) patients remains poor. Although
clinical gains have been achieved in the past, these have been modest, with a majority of
patients succumbing to local disease progression within 2 years. New strategies for
treatment need to be identified which enhance local control above the current treatment
regimen in order to achieve further clinical gains in this disease. Favorable early
experience with magnetic resonance spectroscopy imaging (MRSI) demonstrates that metabolic
imaging can identify active tumor beyond standard MRI as well as high risk regions at risk
for local failure. There is also clinical evidence that limited field dose escalation with
either simultaneous integrated boost (SIB) or stereotactic radiosurgery (SRS) is feasible
and safe. Coupling these findings provide the rationale for this proposed Phase II trial
designed to define efficacy and toxicity of the novel treatment approach of whole brain
volumetric 3D MRSI guided dose-escalated radiation therapy (RT) in newly diagnosed GBM

Inclusion Criteria:

- Histologically proven diagnosis of glioblastoma (WHO grade IV). Since gliosarcoma is
a variant of glioblastoma, gliosarcoma is also an eligible diagnosis.

- The tumor must have a supratentorial component

- Patients must have recovered from the effects of surgery, postoperative infection and
other complications

- Karnofsky performance status >/= 70

- Age >/= 18 years

- Adequate bone marrow function defined as follows:

- Absolute neutrophil count (ANC) >/= 1500 cells/mm3

- Platelet count >/= 100,000 cells/mm3

- Hemoglobin >/= 10.0 g/dL (Note: the use of transfusion or other intervention to
achieve Hgb >/= 10.0 g/dL is acceptable.)

- Patients on full-dose anticoagulants (e.g., warfarin or LMW heparin) must meet both
of the following criteria:

- No active bleeding or pathological condition that carries a high risk of
bleeding (e.g., tumor involving major vessels or known varices)

- In-range INR (usually between 2 and 3) on a stable dose of oral anticoagulant or
on a stable dose of low molecular weight heparin

- Adequate renal function, defined as follows:

- Serum creatinine
- Adequate hepatic function, as defined below:

- Bilirubin
- Patients must not be pregnant (positive pregnancy test) or breast feeding; pregnancy
test must be done within 7 days prior to registration. Effective contraception (men
and women) must be used in patients of child-bearing potential while on study
treatment and for 6 months after.

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

- Ability to have MRI Scans

- Ability to swallow capsules

Exclusion Criteria:

- Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free
for a minimum of 3 years (for example, carcinoma in situ of the breast, oral cavity
or cervix are all permissible)

- Recurrent malignant glioma or evidence of leptomeningeal spread

- Metastases detected below the tentorium or beyond the cranial vault

- Prior use of Gliadel wafers or any other intratumoral or intracavitary treatment

- Prior radiotherapy to the head or neck (except for T1 glottic cancer), resulting in
overlap of radiation therapy fields

- Prior radiation therapy or chemotherapy for glioblastoma

- Severe, active co-morbidity, defined as follows:

- Symptomatic congestive heart failure of New York heart Association Class III or

- Unstable angina pectoris, symptomatic congestive heart failure, myocardial
infarction within the last 6 months, serious uncontrolled cardiac arrhythmia or
any other clinically significant cardiac disease

- Severely impaired lung function as defined as spirometry and DLCO that is 50% of
the normal predicted value and/or 02 saturation that is 88% or less at rest on
room air

- Uncontrolled diabetes as defined by fasting serum glucose >1.5 x ULN

- Active (acute or chronic) or uncontrolled severe infections requiring
intravenous antibiotics

- Liver disease such as cirrhosis, chronic active hepatitis or chronic persistent

- Acquired immune deficiency syndrome (AIDS) based upon current CDC definition or
known HIV seropositivity. Note, however, that HIV testing is not required for
entry into this protocol. The need to exclude patients with HIV/AIDS from this
protocol is necessary because the treatments involved in this protocol may be
significantly immunosuppressive.

- Active connective tissue disorders, such as lupus or scleroderma, that in the
opinion of the treating physician may put the patient at high risk for radiation

- Other major medical illnesses or psychiatric impairments that in the
investigator's opinion will prevent administration or completion of protocol

- Pregnancy

- Women who are breast feeding

- Prior allergic reaction to temozolomide

- Treatment on any other therapeutic clinical protocol

- Impairment of gastrointestinal function or gastrointestinal disease that may
significantly alter their absorption of temozolomide (e.g. ulcerative disease,
uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or small bowel

- Contraindications to MRI including but not limited to, pacemaker, aneurysm clips,
neurostimulators, cochlear implants, metal in eyes, steelworker or other implants

- Need to continue treatment with any prohibited medication (e.g. antioxidants) or have
not completed the appropriate washout period.
We found this trial at
Miami, Florida 33124
(305) 284-2211
Principal Investigator: Fazilat Ishkanian, MD, PhD
Phone: 305-243-4319
University of Miami A private research university with more than 15,000 students from around the...
Miami, FL
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