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Randomized control study of the Efficacy of Radioactive Hypoxia-Targeting Therapeutic Agent 64Cu-ATSM versus standard therapy for Recurrent Malignant Glioma: Investigator Initiated Trial (STEP-64)

NCCH2301 (STEP-64 trial)

Narita Yoshitaka

National Cancer Center Hospital

5-1-1, Tsukiji, Chu-o-ku, Tokyo 104-0045, Japan

yonarita@ncc.go.jp

NCCH2301 Clinical Trial Coordinating Office

National Cancer Center Hospital

5-1-1, Tsukiji, Chu-o-ku, Tokyo 104-0045, Japan

+81-3-3542-2511

ncch2301_office@ml.res.ncc.go.jp

Recruiting

May. 01, 2024

Interventional

randomized controlled trial

open(masking not used)

no treatment control/standard of care control

parallel assignment

treatment purpose

1) Histologically diagnosed as high grade glioma based on WHO2021 criteria (glioblastoma, Grade 3/4 astrocytoma, or Grade 3 oligodendroglioma) before the registration
2) Neither tumor in the cerebellum, brain stem, pituitary gland, optic nerve, olfactory nerve, nor intrathecal dissemination, in both the initial case and recurrence (multiple lesions are eligible).
3) Neither leptomeningeal metastases , nor spinal metastasis requiring radiation therapy or surgical intervention.
4) Aged between 18 and 75 years old
5) KPS (Karnofsky performance status) at the time of registration >= 70
6) Recurrent or residual tumor after the standard therapy as indicated below.
(1) local radiation therapy >= 50 Gy
(2) TMZ (temozolomide) therapy (150 to 200 mg/m2/day, 5 days oral, 23 days interval) 3 courses or more
7) In a case with a history of radiotherapy, 90 days passed from the last irradiation date at the time of registration
8) No anti-cancer drug treatment (chemotherapy, molecular targeted therapy, immunotherapy, etc.) nor other investigational drugs have been administered within 21 days before registration (the same day of the week for registration is allowed. The criteria listed below are the same)
9) Not underwent surgery with general anesthesia within 14 days before 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 fulfilled following criteria:
12) In the case of women of childbearing potential, consent has been granted for contraception for at least 7 weeks after the last dose of study drug. In the case of males, consent to contraception for at least 14 weeks after the start of study drug administration and after the last dose of study drug.
13) Written informed consent

1) Have a history or merger of other malignancies within 2 years before registration. Patients with carcinoma in situ or lesions equivalent to intramucosal carcinoma 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 antibody positive
7) Pregnant or breast-feeding women, or women suspected of being pregnant
9) Mental disease interfering taking part in the trial

Both

Malignant glioma

Group A: BPC Therapy
Depending on the patient's condition, one of the treatments covered by national health insurance should be chosen as BPC therapy.
Group B: 64Cu-ATSM Therapy
64Cu-ATSM 100 MBq/kg will be administered intravenously once on day 1 of each course, one course per week, up to a total of 4 courses.

glioblastoma, grade3/4 astrocytoma, grade3 oligodendroglioma

64Cu-ATSM

D005910

overall survival

progression-free survival, response rate (locally and centrally), Adverse event expression rate (CTCAE v5.0-JCOG), KPS non-deterioration rate

+81-3-3542-2511

Mar. 27, 2024

No

none