Relapse/refractory pediatric/AYA solid tumor
Conditions
Interventions
IG chemotherapy in which irinotecan IV over 1 hour on days 1-5 and gemcitabine IV over 30 minutes on days 1, 8, to be repeated every 3 weeks
Sponsors
Group for "combination chemotherapies for refractory Adolescent and Young Adult solid tumors "
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. neuroblastoma, rhabdomyosarcoma, undifferentiated sarcoma, Ewing's sarcoma family of tumor, retinoblastoma, Wilm's tumor, hepatoblastoma, osteosarcoma, other bone or tissue malignant tumor 2. relapse or progression following disease specific first-line standard chemotherapies 3. evidence of progression in clinical signs or symptoms or on imaging studies 4. > 21 days since prior antitumor cytotoxic agents 5. > 21 days since prior radiation therapy 6. > 14 days since prior surgery (containing open biopsy) 7. no prior combination of irinotecan and gemcitabine containing chemotherapy 8. 0-2 in ECOG PS 9. confirming the following laboratory results (1) Absolute neutrophil count >= 1,000/mm3 (at least 4days since prior G-CSF administration) (2) Platelet count >= 75,000/mm3 (platelet transfusions allowed) (3) Direct Bilirubin < 1.5mg/dl (4) Creatinine adjusted according to age as follows: <= 1.0 mg/dl (1 year-23 months) <= 1.4 mg/dl (2 years-5 years) <= 1.8 mg/dl (6 years-9 years) <= 2.3 mg/dl (10 years-12 years [male]) <= 2.1 mg/dl (10 years-12 years [female]) <= 2.9 mg/dl (13 years-15 years [male]) <= 2.3 mg/dl (13 years and over [female]) <= 3.0 mg/dl (16 years-17 years [male]) <= 2.3 mg/dl (16 years-17 years [female]) <= 3.0*ULN mg/dl (16 years and over) (5) SpO2 >= 94% without oxygenation 10. written informed consent from patient and / or legal guardian
Exclusion criteria
Exclusion criteria: 1. Active double cancer (synchronous double cancer and metachronous double cancer within 5 disease-free years), excluding carcinoma in situ (lesions equal to intraepithelial or intramucosal cancer) judged to have been cured with local treatment 2. Active infection requiring systemic medication 3. abnormality in electrocardiogram tested within 28 days, requiring intervention 4. respiratory or heart disorder requiring oxygen supply, except from malignant pleural effusion 5. diarrhea >= Grade2 6. Women during pregnancy or breast-feeding 7. Psychosis 8. Systemic steroids or other immunosuppressants medication 9. Principal investigator determines that the case is Inappropriate to register for this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase I: MTD Phase II: Progression-free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Phase I: incidence of adverse event Phase II: probability of the patients who can tolerate more than 4 courses of chemotherapy at the recommended dosage, overall survival etc. | — |
Countries
Japan
Contacts
Public ContactTakehiro Matsuda
Okinawa prefectural Nanbu Medical Center, Children's Medical Center Division of Pediatric Hematology and Oncology
Outcome results
None listed