Clinical Trial Details
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[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT02076152 : FMISO PET Study of Glioblastoma
PhaseN/A
AgesMin: 18 Years Max: N/A
Eligibility
Inclusion Criteria:

- Participants must have histologically confirmed glioblastoma and evidence of
recurrence. Patients with low-grade tumors who have progressed to glioblastoma are
eligible.

- Participants must have measurable disease, defined as at least one lesion that can be
accurately measured in at least one dimension (longest diameter to be recorded) as >
10 mm. See section 10 for the evaluation of measureable disease.

- Only patients for whom their neuro-oncologist has planned to give bevacizumab as
monotherapy are eligible for this study

- Age > 18 years. Because no dosing or adverse event data are currently available on the
use of FMISO in participants <18 years of age, children are excluded from this study
but will be eligible for future pediatric trials.

- Life expectancy of greater than 3 months.

- Karnofsky performance status > 60 (see Appendix A).

- Participants must have normal organ and marrow function as defined below:

- Leukocytes > 3,000/mcL

- Absolute neutrophil count > 1,500/mcL

- Platelets > 100,000/mcL

- Total bilirubin within normal institutional limits

- AST (SGOT)/ALT (SGPT) < 2.5 X institutional upper limit of normal

- Creatinine within normal institutional limits or creatinine clearance > 60
mL/min/1.73 m2 for subjects with creatinine levels about institutional normal.

- Patient must be able to undergo MRI and PET scans.

- Patients must be maintained on a stable corticosteroid regimen for 5 days prior each
MR-PET scan.

- The effects of FMISO on the developing human fetus are unknown. For this reason and
because radiopharmaceuticals agents are known to be teratogenic, women of
child-bearing potential and men must agree to use adequate contraception (hormonal or
barrier method of birth control; abstinence) prior to study entry and for the duration
of study participation. Should a woman become pregnant or suspect she is pregnant
while participating in this study, she should inform her treating physician
immediately.

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

Exclusion Criteria:

- Participants who exhibit any of the following conditions at screening will not be
eligible for admission into the study.

- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to temozolomide or FMISO.

- Participants who have already received anti-VEGF or experimental anti-angiogenic
therapy for glioblastoma.

- Uncontrolled intercurrent illness including, but not limited to ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance with
study requirements.

- Pregnant women are excluded from this study because FMISO is a radiopharmaceutical
agent with the potential for teratogenic or abortifacient effects. Because there is an
unknown but potential risk of adverse events in nursing infants secondary to treatment
of the mother with radiopharmaceutical agents, breastfeeding should be discontinued if
the mother is treated with radiopharmaceutical agents. These potential risks may also
apply to other agents used in this study.

- HIV-positive individuals on combination antiretroviral therapy are ineligible because
of the potential for pharmacokinetic interactions with FMISO. In addition, these
individuals are at increased risk of lethal infections when treated with
marrow-suppressive therapy. Appropriate studies will be undertaken in participants
receiving combination antiretroviral therapy when indicated.

- Patients who are no suitable to undergo MRI or use gadolinium contrast due to:

- Claustrophobia

- Presence of metallic objects or implanted medical devices in body (i.e. cardiac
pacemaker, aneurysm clips, surgical clips, prostheses, artificial hearts, valves
with steel parts, metal fragments, shrapnel, tattoos near the eye, or steel
implants)

- Sickle cell disease

- Renal failure

- Reduced renal function, as determined by creatinine clearance < 30 mL/min based
on a serum creatinine level obtained within 28 days prior to registration
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT02076152      |      Link to official Clinicaltrials.gov listing
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