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Safety Test to clarify the optimal Administration dose and method of Radiopharmaceutical for therapy against malignant brain tumor with 64Cu-ATSM (STAR-64)

Safety Test to clarify the optimal Administration dose and method of Radiopharmaceutical for therapy against malignant brain tumor with 64Cu-ATSM

Hiroaki Kurihara

Kanagawa Cancer Center

2-3-2 Nakao, Asahi-ku, Yokohama, Kanagawa 24-8515, Japan

hikuriha@ncc.go.jp

Natsuko Okita

National Cancer Center Hospital

5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan

+81-3-3542-2511

NCCH1711_office@ml.res.ncc.go.jp

COMPLETED

July. 17, 2018

Interventional

Dose escalation trial

open(masking not used)

No

1

1) Histologically diagnosed as either glioblastoma, Grade III glioma, PCNSL, or malignant meningioma (Grade II/ III) before the registration, or clinically diagnosed as metastatic brain tumor
2) Neither tumor in the cerebellum, brain stem, pituitary gland, optic nerve, olfactory nerve, nor intrathecal dissemination, in both the initial case and recurrence.
3) Diagnosed as A) recurrence of glioblastoma or Grade III glioma after completion of standard treatment, B) recurrence of PCNSL after completion of standard treatment, C) recurrent or worsened metastatic brain tumors after external irradiation or stereotactic irradiation and no indication for surgery or external irradiation and completed standard treatment for primary tumor, D)Recurrence or exacerbation of malignant meningioma (Grade II or Grade III) after 1 or more surgery and no indication for surgery anymore
4) Aged between 20 and 75 years old
5) KPS (Karnofsky performance status) at the time of registration >= 60
6) One or more measurable lesions confirmed by Gd-enhanced head MRI
7) No other investigational drugs have been administered within 21 days before registration
8) Not underwent surgery with general anesthesia within 14 days before registration
9) In a case with a history of radiotherapy, 90 days passed from the last irradiation date at the time of registration
10) As a treatment for tumors other than brain tumor, there is no history of radiotherapy in the head and neck region
11) Patients received laboratory tests within 14 days before registration and have adequate organ function
12) Given consent to contraception
13) Written informed consent

1) Have a history or merger of other malignancies within 2 years before registration. Patients with carcinoma in situ are eligible
2) Have infection requiring systemic treatment at registration
3) Fever of 38C or higher at registration
4) Clinical symptoms or image findings of interstitial pneumonia or pulmonary fibrosis at registration
5) With history of hypersensitivity reaction to contrast agent, claustrophobia, etc. and Gd-enhanced MRI cannot be performed.
6) HIV positive, HTLV-1 positive, HBs positive, HCV positive
7) HBc positive and HBV-DNA positive, etc.
8) Pregnant or breast-feeding women, or women suspected of being pregnant
9) Have poorly controlled diabetes
10) Have symptomatic heart disease
11) Mental disease interfering taking part in the trial

Both

Recurrent case of malignant brain tumor who had completed standard treatment

Intervention type:DRUG Name of intervention:64Cu-ATSM Dose form / Japanese Medical Device Nomenclature:INJECTION Route of administration / Site of application:INTRAVENOUS BOLUS Dose per administration:30~150 30, 60, 99, 150 MBq/kg Dosing frequency / Frequency of use:QW 4 Planned duration of intervention:Until patient completes protocol treatment or meets protocol treatment discontinuation Intended dose regimen:64Cu-ATSM monotherapy detailes of teratment arms:64Cu-ATSM monotherapy (Level 1: 30 MBq/kg, Level 2: 60 MBq/kg, Level 3: 99MBq/kg, Level 4: 150 MBq/kg) Cohort A: QW, 4 times Cohort B: Q2W, 4 times Comparative intervention name: Dose form / Japanese Medical Device Nomenclature: Route of administration / Site of application: Dose per administration: Dosing frequency / Frequency of use: Planned duration of intervention: Intended dose regimen:

The occurrence of dose limiting toxicity (DLT) during 64Cu-ATSM monotherapy

Response rate, progression-free survival (PFS), estimated effective dose by internal exposure evaluation, expression of adverse event, steroid non-incremental rate, KPS non-deterioration rate

May. 23, 2018