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A Pilot Study of Using MRI-Guided Laser Heat Ablation to Induce Disruption of the Peritumoral Blood Brain Barrier to Enhance Delivery and Efficacy of Doxorubicin in the Treatment of Recurrent Glioblastoma Multiforme

18 Years
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Trial Information

A Pilot Study of Using MRI-Guided Laser Heat Ablation to Induce Disruption of the Peritumoral Blood Brain Barrier to Enhance Delivery and Efficacy of Doxorubicin in the Treatment of Recurrent Glioblastoma Multiforme

Evaluate imaging techniques (MRI) and blood tests (biomarkers) to help figure out the best
time for chemotherapy to be initiated after the blood brain barrier is disrupted, as it is
immediately following a procedure like MRI-guided laser ablation (MLA-Monteris Neuroblate).

Inclusion Criteria:

- Histologically confirmed GBM; rare GBM variants and secondary Glioblastoma multiforme
(GBM) are allowed.

- Unequivocal evidence of tumor progression by Magnetic resonance imaging (MRI) scan.

- There must be an interval of at least 12 weeks from the completion of radiotherapy to
study registration except if there is unequivocal evidence for tumor recurrence per
RANO criteria. When the interval is less than 12 weeks from the completion of
radiotherapy, the use of PET scan is allowed to differentiate between unequivocal
evidence of tumor recurrence and pseudoprogression.

- Largest dimension of the recurrent tumor is a maximum of approximately 3 cm.

- At least 18 years of age.

- Karnofsky performance status > 60%.

- Scheduled for MRI-guided Laser Ablation (MLA).

- Normal left ventricular ejection fraction on MUGA or echocardiogram within the past 1
year prior to registration for patients with history of congestive heart failure
and/or coronary disease requiring medications other than aspirin, or known prior
exposure to anthracycline chemotherapy.

- Adequate bone marrow and hepatic function as defined below (must be within 7 days of
the first dose of doxorubicin):

- Absolute neutrophil count (ANC) ≥ 1500/mcl (G-CSF is allowed)

- Platelets ≥ 100,000/mcl

- Hemoglobin ≥ 9 (pRBC transfusion +/- ESA are allowed)

- ALT ≤ 3 x ULN

- AST ≤ 3 x ULN

- ALP ≤ 3 x ULN. If ALP is > 3 x ULN, GGT must be checked and be ≤ 3 x ULN.

- Bilirubin ≤ 2 x ULN

- At the time of registration, patient must have recovered from the toxic effects of
prior therapy to no more than grade 1 toxicity.

- At the time of registration, patient must be at least 2 weeks from prior vincristine,
3 weeks from prior procarbazine, and 4 weeks from other prior cytotoxic chemotherapy.

- Women of childbearing 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 must inform her treating
physician immediately.

- Ability to understand and willingness to sign an IRB approved written informed
consent document (or that of legally authorized representative, if applicable).

Exclusion Criteria:

- Prior treatment with doxorubicin and/or bevacizumab.

- Prior treatment with Gliadel wafer is allowed if it has been at least 3 months from

- Previous treatment with complete cumulative doses of daunorubicin, idarubicin, and/or
other anthracyclines and anthracenediones that is equivalent to a total dose of 240
mg/m2 doxorubicin.

- More than 2 prior relapses.

- Currently receiving any other investigational agents that are intended as treatments
of GBM.

- A history of allergic reactions attributed to compounds of similar chemical or
biologic composition to doxorubicin or other agents used in the study.

- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, recent heart attack within the previous 12 months or severe heart
problems, or psychiatric illness/social situations that would limit compliance with
study requirements.

- Pregnant and/or breastfeeding. Premenopausal women must have a negative serum
pregnancy test within 14 days of study entry.

- Inability to undergo MRI due to personal and medical reasons.

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

Inclusion of Women and Minorities

-Both men and women and members of all races and ethnic groups are eligible for this

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Outcome Measure:

Ktrans from DSC-MRI

Outcome Description:

Using a 2 compartment model to calculate a the vascular transfer constant (Ktrans) which will provide a quantitative measure of blood brain barrier leakage

Outcome Time Frame:

6 weeks

Safety Issue:


Principal Investigator

David Tran, M.D., Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Washington University School of Medicine


United States: Institutional Review Board

Study ID:




Start Date:

July 2013

Completion Date:

December 2017

Related Keywords:

  • Glioblastoma
  • Glioblastoma



Washington University School of MedicineSaint Louis, Missouri  63110