Using MRI-Guided Laser Heat Ablation to Induce Disruption of the Peritumoral Blood Brain Barrier to Enhance Delivery and Efficacy of Treatment of Pediatric Brain Tumors

  • STATUS
    Recruiting
  • End date
    Aug 31, 2028
  • participants needed
    12
  • sponsor
    Washington University School of Medicine
Updated on 9 July 2022
MRI
anthracyclines
cytotoxic chemotherapy
neutrophil count
blood transfusion
g-csf
brain tumor
tumor progression
anthracycline
recurrent tumor

Summary

By employing a combination of advanced MRI techniques and correlative serum biomarkers of blood brain barrier (BBB) disruption, the investigators plan to develop a powerful, first of its kind clinical algorithm in pediatrics whereby the investigators can measure and identify the window of maximal BBB disruption post MLA to 1) allow for an alternative to surgery in incompletely resected tumors, 2) allow for optimal chemotherapeutic dosing to achieve the greatest benefits and the least systemic side effects and 3) distinguish subsequent tumor progression from long-term MLA treatment effects. Preliminary data in adult imaging studies have shown that the BBB disruption lasts for several weeks following treatment before returning to a low baseline. This pilot therapeutic study will provide preliminary validation in pediatric patients.

Details
Condition Glioma, Pilocytic Astrocytoma, Anaplastic Astrocytoma, Glioblastoma, Mixed Oligoastrocytoma, Mixed Glioma, Oligodendroglioma, Optic Glioma, Astrocytoma
Treatment etoposide, doxorubicin, MRI-guided laser ablation, Dynamic contrast-enhanced (DCE) MRI, Dynamic susceptibility contrast (DSC) MRI
Clinical Study IdentifierNCT02372409
SponsorWashington University School of Medicine
Last Modified on9 July 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

ARM A
Presumed pediatric gliomas (grades I-IV) on MRI that are determined to be candidates for MLA by the treating neurosurgeon
Age 3 to ≤ 21
Karnofsky/Lansky performance status ≥ 60%
ARM B
Recurrent pediatric brain tumors determined candidates for MLA as determined by the treating neurosurgeon
Unequivocal evidence of tumor progression by MRI
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 evidence of tumor recurrence and pseudoprogression
Recurrent lesions with dimension and contour that are determined by the treating neurosurgeon to be appropriate for MLA
Age 3 to ≤ 21
Karnofsky/Lansky performance status ≥ 60%
Adequate cardiac function as determined by a shortening fraction ≥ 27% or left ventricular ejection fraction ≥ 50% by echocardiogram within the past 1 year prior to registration
Prior anthracycline therapy does not exceed 200 mg/m^2 total cumulative dose
Adequate bone marrow and hepatic function as defined below (must be within 7 days of MLA)
Absolute neutrophil count (ANC) ≥ 1000/mcl (G-CSF is allowed)
Platelets ≥ 100 K/cumm
Hemoglobin ≥ 9 g/dL (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 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

ARM A
Currently receiving or scheduled to receive any other therapies intended to treat the newly diagnosed glioma prior to MLA and the first post-MLA blood collection for correlative studies
Multi-focal or metastatic disease
Pregnant and/or breastfeeding. Premenopausal women must have a negative serum or urine pregnancy test within 14 days of study entry
Inability to undergo MRI due to personal or medical reasons
Known history of HIV or autoimmune diseases requiring immunosuppressant drugs
ARM B
Prior treatment with bevacizumab within 12 weeks of study entry
Previous treatment with complete cumulative doses of daunorubicin, idarubicin, and/or other anthracyclines and anthracenediones that is equivalent to a total dose of > 200 mg/m2 doxorubicin
More than 2 prior relapses (not counting the current relapse being treated on this study)
Currently receiving any other investigational agents that are intended as treatments of the relapsed tumor
Multi-focal or metastatic disease
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 or urine pregnancy test within 14 days of study entry
Inability to undergo MRI due to personal or medical reasons
Known history of HIV or autoimmune diseases requiring immunosuppressant drugs
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note