Relapse or refractory pediatric solid tumor
Conditions
Interventions
VNR+CY: weekly intravenous VNR day1,8,15 with daily oral CY, to be repeated every 4 weeks
TMZ+VP: 5 day schedule oral TMZ and 12 day schedule oral VP, to be repeated every 4 weeks
Sponsors
Group for " Cross-over rPII of outpatient chemotherapies for refractory pediatric 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 soft tissue sarcoma, primary CNS tumors, germ cell tumors 2. relapse or progression following disease-specific standard chemotherapies 3. evidence of progression in clinical signs or symptoms, of bone marrow metastasis, or of progression or stable disease on imaging studies 4. no prior chemotherapy containing either vinorelbine or temozolomide 5. > 28 days since prior nitrosourea or > 14 days since prior other antitumor cytotoxic agents 6. > 14 days since prior palliative radiation therapy (irradiation dose is less than or equal to 30 Gy) or > 21 days since prior non-palliative irradiation 7. > 14 days since prior surgery (including open biopsy) 8. 0-2 in ECOG PS 9. confirming the following laboratory results within 14 days (1) Absolute neutrophil count >= 1,000/mm~3 (at least 4days since prior G-CSF administration) (2) Platelet count >= 5,000/mm~3 (at least 3days since prior concentrated platelet transfusion) (3) serum total Bilirubin <= 1.2mg/dl (4) Creatinine adjusted according to age as follows: <= 0.6 mg/dl (1 year-23 months) <= 0.8 mg/dl (2 years-5 years) <= 0.9 mg/dl (6 years-9 years) <= 1.1 mg/dl (10 years-12 years [male]) <= 1.0 mg/dl (10 years-12 years [female]) <= 1.5 mg/dl (13 years-15 years [male]) <= 1.2 mg/dl (13 years and over [female]) <= 1.7 mg/dl (16 years and over [male]) 10. no difficulty to take 8mm tablet 11. legal adult: Written informed consent 12. 16 years and over, but, no legal adult: written informed consent from both patient and legal guardian 13. 15 years and under: written informed consent from 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. Women during pregnancy or breast-feeding 7. Psychosis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression free survival (per regimen or per whole protocol therapy), time to treatment failure (1st regimen or whole protocol therapy), response rate, Adverse events profile, self-reported QOL with face scale, number of days attending school/workplace, number of days not attending hospital | — |
Countries
Japan
Contacts
Public ContactAtsushi Ogawa
study coordinator Niigata Cancer Center Hospital pediatric division
Outcome results
None listed