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

NCT02750891 | Completed Phase 1

• 2 other identifiers: DB601001JapicCTI-163216
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 6

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.

Conditions

Glioblastoma; Diffuse Intrinsic Pontine Glioma

Keywords

high grade glioma; HGG; DIPG

Outcome Measures

Primary Outcomes (2)

• DLT (dose-limiting toxicity)

  Safety and tolerability assessed by dose-limiting toxicity (DLT)

  4 weeks

• Overall Survival （OS）

  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 Outcomes (9)

• Overall Response Rate（ORR）

  6 months

• Progression-free survival (PFS)

  6 months

• adverse events (AEs)

  12 months

• serious adverse events (SAEs)

  12 months

• DTH （delayed-type hypersensitivity）

  6 months

Study Arms (1)

DSP-7888

EXPERIMENTAL

Drug: DSP-7888

Interventions

DSP-7888 DRUG

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

DSP-7888

Eligibility Criteria

• Age: Up to 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients meeting any of the conditions a) to c) below:
• Have a diagnosis of diffuse intrinsic pontine glioma on the basis of imaging findings on magnetic resonance imaging (MRI) and clinical course
• Have histologically or cytologically confirmed glioblastoma
• Not meeting a) and b) above, but have histologically or cytologically confirmed grade III or IV glioma
• 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.)
• Patients aged \< 20 years at the time of informed consent
• 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
• Patients for whom standard therapy failed or no standard therapy is established
• 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)
• Glioblastoma patients and grade III or IV glioma patients must had radiologically evident tumor re-enlargement or recurrence
• 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.
• Patients with a life expectancy of 2 months (60 days)
• Patients with a HLA type of HLA-A\*24:02 or A\*02:01/06
• 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

You may not qualify if:

• Patients with grade 3 infection according to the CTCAE v4.0
• Patients with a positive test result for HIV antibody, HBs antigen, or HCV antibody
• Patients with multiple or disseminated primary lesions (Multiple nodules in the same tumor cavity will be acceptable.)
• Patients with other malignancies
• 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
• Patients with uncontrollable complications
• Patients who underwent allogeneic hematopoietic stem cell transplant
• 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
• Pregnant or breastfeeding women
• 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.
• Patients with any ongoing CTCAE v4.0 grade 2 adverse effects of prior treatment (excluding alopecia and phlebitis)
• Patients who received any other investigational product or post-marketing study drug within 4 weeks (28 days) before enrollment

Sponsors & Collaborators

• Sumitomo Pharma Co., Ltd.: lead

Study Sites (6)

National Hospital Organization Nagoya Medical Center

Nagoya, Aichi-ken, Japan

Location

Kanagawa Children's Medical Center

Yokohama, Kanagawa, Japan

Location

Osaka University Hospital

Suita, Osaka, Japan

Location

National Center for Child Health and Development

Setagaya City, Tokyo, Japan

Location

Hiroshima University Hospital

Hiroshima, Japan

Location

Osaka City General Hospital

Osaka, Japan

Location

MeSH Terms

Conditions

Glioblastoma; Diffuse Intrinsic Pontine Glioma; Glioma

Condition Hierarchy (Ancestors)

Astrocytoma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Brain Stem Neoplasms; Infratentorial Neoplasms; Brain Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Sumitomo Pharma Co., Ltd. Japan

  Sumitomo Pharma Co., Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2016
• First Posted: April 26, 2016
• Study Start: April 1, 2016
• Primary Completion: January 1, 2020
• Study Completion: January 1, 2020
• Last Updated: April 12, 2022

Record last verified: 2022-04

Locations

JP (6)