COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu
Trial record 1 of 1 for:    NCT02750891
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02750891
Recruitment Status : Completed
First Posted : April 26, 2016
Last Update Posted : June 9, 2020
Information provided by (Responsible Party):
Sumitomo Dainippon Pharma Co., Ltd.

Brief 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.

Condition or disease Intervention/treatment Phase
Glioblastoma Diffuse Intrinsic Pontine Glioma Drug: DSP-7888 Phase 1 Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1/2 Study of DSP-7888 in Pediatric Patients With Relapsed or Refractory High Grade Gliomas
Actual Study Start Date : April 2016
Actual Primary Completion Date : January 2020
Actual Study Completion Date : January 2020

Arm Intervention/treatment
Experimental: DSP-7888 Drug: DSP-7888
Phase1 portion: 1.75 or 3.5 mg/body, Id every 1-4 weeks Phase 2 portion: recommended phase 2 dose, Id every 1-4 weeks

Primary Outcome Measures :
  1. DLT (dose-limiting toxicity) [ Time Frame: 4 weeks ]
    Safety and tolerability assessed by dose-limiting toxicity (DLT)

  2. Overall Survival (OS) [ Time Frame: 24 months ]
    Participants follow-up for overall survival will occur. Maximum follow-up time is 2 year after the initial administration of the last subject.

Secondary Outcome Measures :
  1. Overall Response Rate(ORR) [ Time Frame: 6 months ]
    Antitumor effect as assessed according to the Response Assessment in Neuro-Oncology (RANO) criteria

  2. Progression-free survival (PFS) [ Time Frame: 6 months ]
  3. adverse events (AEs) [ Time Frame: 12 months ]
    Safety and tolerability assessed by adverse events (AEs)

  4. serious adverse events (SAEs) [ Time Frame: 12 months ]
    Safety and tolerability assessed by serious adverse events (SAEs)

  5. DTH (delayed-type hypersensitivity) [ Time Frame: 6 months ]
    Explore efficacy related biomarkers assessed by delayed-type hypersensitivity (DTH) reactions to WT1 peptide

  6. WT1 peptide-specific CTL-induction activity [ Time Frame: 6 months ]
    Explore efficacy related biomarkers assessed by WT1 peptide-specific CTL-induction activity.

  7. expression of WT1 in biopsy tissues [ Time Frame: 6 months ]
    Explore efficacy related biomarkers assessed in biopsy tissues

  8. expression of HLA in biopsy tissues [ Time Frame: 6 months ]
    Explore efficacy related biomarkers assessed in biopsy tissues

  9. expression of PD-L1 in biopsy tissues [ Time Frame: 6 months ]
    Explore efficacy related biomarkers assessed in biopsy tissues

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   up to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  8. Patients with an ECOG PS score of 0 to 2 at enrollment. Patients with a PS score of 3 or 4 due to neurological symptoms associated with the primary disease may be eligible if appropriate in the opinion of the investigator or subinvestigator.
  9. Patients with a life expectancy of 2 months (60 days)
  10. Patients with a HLA type of HLA-A*24:02 or A*02:01/06
  11. Patients with adequate major organ functions meeting the following criteria on the basis of laboratory data within 28 days before enrollment:

    Neutrophil count: 1000/μL Platelet count: 5.0 ×104/μL Hemoglobin: 9.0 g/dL Serum creatinine: 2-fold the upper limit of the normal range of the study site (ULN) Total bilirubin: 2-fold the ULN AST, ALT: 3-fold the ULN

  12. Female patients of childbearing potential must have a negative pregnancy test within 4 weeks (28 days) before enrollment
  13. Female patients of childbearing potential and male patients with female partners of childbearing potential must agree to use appropriate contraception from the time of consent until 180 days after the last dose of the study drug to avoid pregnancy

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
    • Surgery, blood transfusion, erythropoiesis-stimulating drugs, endocrine therapy, immunotherapy (including biological response modifier [BRM] therapy): <14 days
  9. Pregnant or breastfeeding women
  10. Patients with concurrent autoimmune disease or a history of chronic or recurrent autoimmune disease, or patients who require long-term systemic steroid therapy (excluding therapy given on a PRN basis). However, steroid therapy for brain edema (prednisolone-equivalent dose of 30 mg/m2) and steroid replacement therapy at a physiologic dose will be acceptable.
  11. Patients with any ongoing CTCAE v4.0 grade 2 adverse effects of prior treatment (excluding alopecia and phlebitis)
  12. Patients who received any other investigational product or post-marketing study drug within 4 weeks (28 days) before enrollment
  13. Patients with a history of allergy to any oil-based agents
  14. Patients who previously received DSP-7888-containing WT1 peptide, or WT1 immunotherapy
  15. Patients who are inappropriate for participation in the study for other reasons in the opinion of the investigator or subinvestigator

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02750891

Layout table for location information
National Hospital Organization Nagoya Medical Center
Nagoya, Aichi, Japan
Kanagawa Children's Medical Center
Yokohama, Kanagawa, Japan
Osaka University Hospital
Suita, Osaka, Japan
National Center for Child Health and Development
Setagaya, Tokyo, Japan
Hiroshima University Hospital
Hiroshima, Japan
Osaka City General Hospital
Osaka, Japan
Sponsors and Collaborators
Sumitomo Dainippon Pharma Co., Ltd.
Layout table for investigator information
Study Director: Sumitomo Dainippon Pharma Co. Ltd. Japan Sumitomo Dainippon Pharma Co., Ltd.
Layout table for additonal information
Responsible Party: Sumitomo Dainippon Pharma Co., Ltd. Identifier: NCT02750891    
Other Study ID Numbers: DB601001
JapicCTI-163216 ( Registry Identifier: JAPIC Clinical Trials Information )
First Posted: April 26, 2016    Key Record Dates
Last Update Posted: June 9, 2020
Last Verified: June 2020
Keywords provided by Sumitomo Dainippon Pharma Co., Ltd.:
high grade glioma
Additional relevant MeSH terms:
Layout table for MeSH terms
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue