Phase 1 and 2 study of tamibarotene and decitabine for relapse and refractory pediatric solid tumor

Phase 1

Completed

• Conditions: Phase 1: Relapse and refractory pediatric solid tumor, Phase 2: Relapse and refractory neuroblastoma

• Registration Number: JPRN-jRCT2080224007
• Lead Sponsor: Osaka City General Hospital, Junichi Hara

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-08-16
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: completed
• Sex: All
• Target Recruitment: 57

Inclusion Criteria

1) Aged 3 to 30 years old at study entry
2) Phase 1:Histologically proven either sarcoma, blastoma, germ cell tumors, or central nervous system tumor except malignant lymphoma
Phase 2:Histologically proven neuroblastoma and experienced high-dose chemotherapy with an autologous hematopoietic stem cell transplantation
3) More than one regimen of chemotherapy including standard therapeutic agents(Patients without options of the standard treatment)
4) Found a lesion by either imaging inspection, bone marrow examination, or tumor marker diagnosis(It doesn't matter whether the presence or absence of measurable lesions defined by RECIST but remission cases are not targeted)
5) PS(Karnofsky or Lansky)>=50%
6) The periods as below have passed since the last use of anti-tumor agents
(1) 7 days or more have passed if dosing method which is continuously-administered more than once in 3 days with no rest period
(2) 14 days or more have passed if other dose methods were used
7) The periods as below have passed since the last irradiation date
a) 12 weeks or more if radiation fields contain either whole brain and spine, whole abdomen, whole lung, whole body, or more than 50% of pelvis
b) 14 days or more if irradiation fields contain less than 3 vertebrae and localized irradiation to other fields
c) 6 weeks or more if irradiation fields are none of the above applies
8) No difficulty to take a soft capsule or a tablet
9) Clinical data within 14 days
(1) Neutrophil count>=1500/mm3(no administration of G-CSF within 3 days before blood-collecting)
(2) Platelet count>=7.5x10^4/mm3(no blood transfusion within 3 days before blood-collecting)
(3) Total bilirubin<=1.5mg/dl
(4) AST(GOT)<=100U/L
(5) ALT(GPT)<=100U/L
(6) TG<=300mg/dl
(7) Serum creatinine(Cre)<=ULN of children reference value x3(no dialysis)
(8) Hemoglobin(Hb)A1c<=6.2%(NGSP)
10) No abnormalities which require an intervention in 12-lead electrocardiogram tested within 28 days before the study entry
11) Written informed consent from a patient and/or a legal guardian

Exclusion Criteria

1) Synchronous cancer and asynchronous cancer with 5 years of disease-free survival except carcinoma in situ or intramucosal carcinoma
2) In patients having a brain tumor or metastasis to brain, a symptom with the intracranial hypertension is poor in control
3) Active infection requires systemic treatment
4) Respiratory failure requiring oxygen administration
5) Medical history and complication of thrombosis
6) Woman who are or may be pregnancy, or are impossible to use effective methods of contraception from 1 month prior to the administration to 2 years after the final dose of treatment. Woman with impossible to discontinue breast-feeding from 1 month prior to the administration to 2 years after the final dose of treatment. Men who are impossible to use effective methods of contraception during the administration and 6 months after the final dose of treatment.
7) Patients considered to be difficult to participate because of psychiatric illness or complication of psychological symptom
8) Patients with history of hypersensitivity to the study drugs
9) Patients otherwise considered to be ineligible for enrollment in the study by an investigator

Study & Design

• Study Type: Interventional
• Study Design: Not specified