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

April 9, 2022 updated by: Sumitomo Pharma Co., Ltd.

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
18

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Hiroshima, Japan
        • Hiroshima University Hospital
      • Osaka, Japan
        • Osaka City General Hospital
    • Aichi
      • Nagoya, Aichi, Japan
        • National Hospital Organization Nagoya Medical Center
    • Kanagawa
      • Yokohama, Kanagawa, Japan
        • Kanagawa Children's Medical Center
    • Osaka
      • Suita, Osaka, Japan
        • Osaka University Hospital
    • Tokyo
      • Setagaya, Tokyo, Japan
        • National Center for Child Health and Development

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

No older than 19 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
DLT (dose-limiting toxicity)
Time Frame: 4 weeks
Safety and tolerability assessed by dose-limiting toxicity (DLT)
4 weeks
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.
24 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Overall Response Rate（ORR）
Time Frame: 6 months
Antitumor effect as assessed according to the Response Assessment in Neuro-Oncology (RANO) criteria
6 months
Progression-free survival (PFS)
Time Frame: 6 months
6 months
adverse events (AEs)
Time Frame: 12 months
Safety and tolerability assessed by adverse events (AEs)
12 months
serious adverse events (SAEs)
Time Frame: 12 months
Safety and tolerability assessed by serious adverse events (SAEs)
12 months
DTH （delayed-type hypersensitivity）
Time Frame: 6 months
Explore efficacy related biomarkers assessed by delayed-type hypersensitivity (DTH) reactions to WT1 peptide
6 months
WT1 peptide-specific CTL-induction activity
Time Frame: 6 months
Explore efficacy related biomarkers assessed by WT1 peptide-specific CTL-induction activity.
6 months
expression of WT1 in biopsy tissues
Time Frame: 6 months
Explore efficacy related biomarkers assessed in biopsy tissues
6 months
expression of HLA in biopsy tissues
Time Frame: 6 months
Explore efficacy related biomarkers assessed in biopsy tissues
6 months
expression of PD-L1 in biopsy tissues
Time Frame: 6 months
Explore efficacy related biomarkers assessed in biopsy tissues
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sumitomo Pharma Co., Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Sumitomo Pharma Co., Ltd. Japan, Sumitomo Pharma Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 13, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 25, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 26, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 12, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 9, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DB601001
  • JapicCTI-163216 (Registry Identifier: JAPIC Clinical Trials Information)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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