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TMZ + RT + 5-ALA + LIDU SDT System for Newly Diagnosed Butterfly Glioma

ConditionsGlioblastom WHO Grade 4GBMbGBMButterfly GBMBihemispheric GBMGlioblastoma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-80
SponsorAlpheus Medical, Inc.

About this trial

This study is assessing the safety and tolerability of 5-ALA- mediated Porphyrin Metabolite Activation (PoMA) with LIDU ultrasound, in patients who have just been diagnosed with bihemispheric (in both sides of the brain) glioblastoma, sometimes called butterfly glioblastoma, before they complete their standard of care chemotherapy and radiation and after their standard of care chemotherapy and radiation while they are receviing their standard of care adjuvant chemotherapy.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patient, or the patient's legally authorized representative, must provide informed consent, stating understanding of the procedures and investigational nature of the study treatment, and willingness to comply with study requirements

≥ 18 and ≤ 80 years of age

WHO performance status of ≤ 2 at screening

Newly diagnosed histologically proven glioblastoma (WHO criteria 2021), with absence of IDH mutation demonstrated by negative IDH1 R132H staining on immunohistochemistry or equivalent molecular testing.

Disqualifiers

Any component of the tumor in the infratentorial location (cerebellar or brainstem tumors are excluded)

Commencing TMZ + RT per SOC before the first SDT treatment

Leptomeningeal disease

Corticosteroid use > 4 mg/day of dexamethasone (or equivalent), steroid dose should be stable or decreasing for ≥1 week prior to randomization

Trial design

Design model

Single group

Treatments tested in this trial

  • 5-ALA

    Drug

    5-ALA is an oral drug that is taken prior to PoMA

  • Porphyrin Metabolite Activation (PoMA) with LIDU ultrasound

    Device

    Porphyrin Metabolite Activation (PoMA) with LIDU ultrasound

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: 5-ALA + LIDU SDT System for newly diagnosed butterfly gliomaExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

To assess the number of participants with treatment-related adverse events as assessed by CTCAE v4.0 in patients receiving bi-hemispheric 5-ALA- mediated Porphyrin Metabolite Activation (PoMA) with LIDU ultrasound.

Time frame
up to 30 weeks

Secondary outcomes

1

To assess overall response rate

Overall Response Rate (ORR), defined as the percentage of participants achieving a complete response or partial response according to RANO 2.0 criteria.

Time frame
1 year
2

Duration of Response

The length of time a patient experiences stability, or shrinkage of tumor

Time frame
1 year
3

median PFS

The time from first treatment until disease progression or death from any cause. The median is the time by which 50% of patients have experienced progression

Time frame
1 year
4

Median Overall Survival

The time from the first treatment until death from any cause. The median is the time by which 50% of patients have died and 50% remain alive.

Time frame
1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Alpheus Medical, Inc.

Lead sponsor

Source ClinicalTrials.gov
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