Phase I clinical trial of GAIA-102 for refractory/relapse neuroblastomas or malignant pediatric solid tumors with lung metastases.

Phase 1

Recruiting

• Conditions: refractory/relapse neuroblastoma or pediatric solid tumors with lung metastases

• Registration Number: JPRN-jRCT2073220054
• Lead Sponsor: Kawakubo Naonori

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-09-23
• Last Update Posted: 20 November 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

1. Patients who have been confirmed to have the following malignant tumor by histological examination
- single cohort : neuroblastoma or malignant solid tumor with pulmonary metastases, rhabdomyosarcoma, undifferentiated sarcoma, Ewing's sarcoma family, osteosarcoma, other cartilage sarcoma, nephroblastoma, hepatoblastoma, germ cell neoplasma, other rare solid tumor (except brain tumor and brain metastases) .
- combination cohort : neuroblastoma.
2. Patients who have the resistance for more than two treatment regimens, and the resistance for all standard regimens based on the guideline.
3. Patients who have medical history for serious side effect , allergy reaction with regards to concomitant drugs.
4. Patients aged from 1years to 24 years at the time of obtaining consent.
5. Patients with performance status(PS) over 50 (Lansky Performance Status Score less than 16 years old) or (Karnofsky Performance Status over 16 years old) at the time of obtaining consent.

Exclusion Criteria

1.Patients with brain metastases.
2.Patients diagnosed with cancerous meningitis
3.Patients who received allogeneic hematopoietic stem cell transplant.
4.Patients with active autoimmune disease.

Study & Design

• Study Type: Interventional
• Study Design: Not specified