Recurrent case of malignant brain tumor who had completed standard treatment
Conditions
Interventions
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
Sponsors
Hiroaki Kurihara, Kanagawa Cancer Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The occurrence of dose limiting toxicity (DLT) during 64Cu-ATSM monotherapy | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactNatsuko Okita
National Cancer Center Hospital
Outcome results
None listed