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Phase II trial of the combination of SPM-011 and BNCT System for recurrent malignant glioma

Phase II trial of SPM-011 + BNCT30 for recurrent malignant glioma

27

Of the 27 recurrent malignant glioma(MG) , 24 were diagnosed as recurrent glioblastoma(GBM) and 3 with non-GBM.

Consent was obtained from 40 patients, and 29 patients were enrolled. Two patients were discontinued before irradiation, and BNCT was performed on 27 patients. All 27 patients performed BNCT shifted to the follow-up period.

All 27 patients experienced treatment-related AEs. Frequent treatment-related AEs included amylase increased (22 cases, 81.5%), alopecia (18 cases, 66.7%), brain edema (13 cases, 48.1%). One patient died from thalamic hemorrhage, but this was unrelated to the treatment. Treatment-related severe AEs (SAEs) occurred in 9 patients (33.3%), the most common of which was brain edema in 4 patients (14.8%). Grade >=3 treatment-related AEs occurred in 22 patients (81.5%); frequent events were amylase increased (18 cases, 66.7%), lymphocyte count decreased (4 cases, 14.8%), and brain edema (3 cases, 11.1%).

The 1-year survival rate of recurrent GBM was 79.2% (95% CI: 57.0-90.8)

The median OS (mOS) of recurrent GBM was 18.9 months (12.9-not estimable). In addition, the 18-month and 2-year survival rates were 54.2% (32.7%-71.4%) and 33.3% (15.9%-51.9%), respectively. The 6-month PFS rate and mPFS of patients with recurrent GB were 5.3% (95% CI: 0.4-21.4) and 0.9 months (95% CI: 0.8-1.0), respectively, using the RANO criteria.

The 1-year survival rate was 79.2% (95% CI: 57.0-90.8) and the median OS (mOS) was 18.9 months (12.9-not estimable) with BNCT.

May. 20, 2021

https://doi.org/10.1093/noajnl/vdab067

No

STELLA PHARMA CORPORATION

ORIX Kouraibashi Bldg.8F 3-2-7 Kouraibashi Cuo-ku, Osaka, Japan

iwasaki@stella-pharma.co.jp

STELLA PHARMA CORPORATION

ORIX Kouraibashi Bldg.8F 3-2-7 Kouraibashi Cuo-ku, Osaka 541-0043 Japan

+81-6-4707-1516

iwasaki@stella-pharma.co.jp

completed

Feb. 26, 2016

Interventional

Multi-center, open label, single armed study

treatment purpose

2

1. Karnofsky performance status of >=60
2. Patients treated with temozolomide and radiation therapy. Patients with relapse or exacerbation of malignant glioma by CT or MRI
3. Patients who underwent radiotherapy with a total dose of 50 Gy - 65 Gy with fractional radiation of about 2 Gy per day for the target lesion site
4. Patients having measurable lesion according to RANO criteria

1. Patients with active multiple primary cancers
2. Patients with extracranial metastasis
3. Patients with meningeal or intrathecal dissemination or discontinuous two or more tumor lesions
4. Patients treated with Bevacizumab

Both

Recurrent malignant glioma

investigational material(s)
Generic name etc : SPM-011(investigational drug), BNCT30 (investigational device)
INN of investigational material : Borofalan(10B)
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Investigational material : SPM-011:intravenous administration, BNCT30:neutron irradiation

control material(s)
Generic name etc : -
INN of investigational material : -
Therapeutic category code :
Dosage and Administration for Investigational material : -

efficacy
1-year survival rate

safety
efficacy
Overall survival, progression free survival, progression free survival at 6 months, response rate, duration of response, disease control rate, safety

+81-72-683-1221

Dec. 22, 2015