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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2016 by Sumitomo Dainippon Pharma Co., Ltd.
Sponsor:
Information provided by (Responsible Party):
Sumitomo Dainippon Pharma Co., Ltd.
ClinicalTrials.gov Identifier:
NCT02750891
First received: April 13, 2016
Last updated: October 7, 2016
Last verified: October 2016
  Purpose
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 Intervention Phase
Glioblastoma
Diffuse Intrinsic Pontine Glioma
Drug: DSP-7888
Phase 1
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Sumitomo Dainippon Pharma Co., Ltd.:

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

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

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

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

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

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

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

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

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


Estimated Enrollment: 30
Study Start Date: April 2016
Estimated Study Completion Date: April 2019
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02750891

Contacts
Contact: Sumitomo Dainippon Pharma Co., Ltd. Japan cc@ds-pharma.co.jp

Locations
Japan
National Hospital Organization Nagoya Medical Center Recruiting
Nagoya, Aichi, Japan
Kanagawa Children's Medical Center Recruiting
Yokohama, Kanagawa, Japan
Osaka University Hospital Recruiting
Suita, Osaka, Japan
National Center for Child Health and Development Recruiting
Setagaya-ku, Tokyo, Japan
Hiroshima University Hospital Recruiting
Hiroshima, Japan
Osaka City General Hospital Recruiting
Osaka, Japan
Sponsors and Collaborators
Sumitomo Dainippon Pharma Co., Ltd.
Investigators
Study Director: Sumitomo Dainippon Pharma Co. Ltd. Japan Sumitomo Dainippon Pharma Co., Ltd.
  More Information

Responsible Party: Sumitomo Dainippon Pharma Co., Ltd.
ClinicalTrials.gov Identifier: NCT02750891     History of Changes
Other Study ID Numbers: DB601001
JapicCTI-163216 ( Registry Identifier: JAPIC Clinical Trials Information )
Study First Received: April 13, 2016
Last Updated: October 7, 2016

Keywords provided by Sumitomo Dainippon Pharma Co., Ltd.:
high grade glioma
HGG
DIPG

Additional relevant MeSH terms:
Glioblastoma
Glioma
Astrocytoma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue

ClinicalTrials.gov processed this record on May 24, 2017