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COMPLETEDPHASE1/PHASE2

A Study of DSP-7888 in Pediatric Patients With Relapsed or Refractory High Grade Gliomas

A Phase 1/2 Study of DSP-7888 in Pediatric Patients With Relapsed or Refractory High Grade Gliomas

NCT02750891•Sumitomo Pharma Co., Ltd.

Summary

This is a phase 1/2, uncontrolled, open-label, multicenter study in patients with recurrent and relapsed diffuse intrinsic pontine glioma, glioblastoma, or grade III or IV glioma.

Eligibility

Age

0 - 19 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Patients meeting any of the conditions a) to c) below:
•1. Have a diagnosis of diffuse intrinsic pontine glioma on the basis of imaging findings on magnetic resonance imaging (MRI) and clinical course
•2. Have histologically or cytologically confirmed glioblastoma
•3. Not meeting a) and b) above, but have histologically or cytologically confirmed grade III or IV glioma
•2. Patients who will be able to be hospitalized from the initial dose of DSP-7888 until the end of the post-initial dose observation (In Phase 1 part only, patients may be permitted to have a temporary overnight leave during the hospitalization.)
•3. Patients aged \< 20 years at the time of informed consent
•4. Patients for whom either the legally acceptable representative or the patient (if aged ≥ 16 years) have provided written voluntary consent to participation in this study after fully receiving and understanding the information about this study, including study objectives, contents, expected pharmacological actions and effects, and foreseeable risks
•5. Patients for whom standard therapy failed or no standard therapy is established
•6. Diffuse intrinsic pontine glioma patients must received radiotherapy-based treatment or chemotherapy (if radiotherapy is not indicated) at least one cycle and subsequently had tumor enlargement accompanied by tumor-related symptomatic worsening (except for worsening due to dose reduction of steroid therapy for brain edema)
•7. Glioblastoma patients and grade III or IV glioma patients must had radiologically evident tumor re-enlargement or recurrence
+6 more criteria

Exclusion Criteria

•1. Patients with grade 3 infection according to the CTCAE v4.0
•2. Patients with a positive test result for HIV antibody, HBs antigen, or HCV antibody
•3. Patients with multiple or disseminated primary lesions (Multiple nodules in the same tumor cavity will be acceptable.)
•4. Patients with other malignancies
•5. Patients with significant diseases at enrollment that may affect study treatment, such as New York Heart Association (NYHA) Functional Class III or IV heart disease, CTCAE v4.0 grade 3 arrhythmia, angina pectoris, abnormal electrocardiogram findings, interstitial pneumonia or pulmonary fibrosis
•6. Patients with uncontrollable complications
•7. Patients who underwent allogeneic hematopoietic stem cell transplant
•8. Patients who received any of the following treatments within the specified period before enrollment
•* Nitrosoureas, mitomycin C: \<42 days
•* Chemotherapy (including molecular-targeted drugs), radiotherapy: \<21 days
+8 more criteria

Locations (6)

National Hospital Organization Nagoya Medical Center

Nagoya, Aichi-ken, Japan

Kanagawa Children's Medical Center

Yokohama, Kanagawa, Japan

Osaka University Hospital

Suita, Osaka, Japan

National Center for Child Health and Development

Setagaya City, Tokyo, Japan

Hiroshima University Hospital

Hiroshima, Japan

Osaka City General Hospital

Osaka, Japan

Key Dates

Start Date

April 1, 2016

Primary Completion Date

January 1, 2020

Completion Date

January 1, 2020

Last Updated

April 12, 2022

Enrollment

ACTUAL participants

Conditions

GlioblastomaDiffuse Intrinsic Pontine Glioma

Interventions

DSP-7888

DRUG

Targeted Pediatric High-Grade Glioma Therapy

NCT05839379

High Grade GliomaDiffuse Intrinsic Pontine Glioma+7 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 12, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study of DSP-7888 in Pediatric Patients With Relapsed or Refractory High Grade Gliomas

Inclusion Criteria

Exclusion Criteria

Targeted Pediatric High-Grade Glioma Therapy

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