Relapse or refractory osteosarcoma
Conditions
Interventions
TMZ+VP: 5 day schedule oral TMZ and 12 day schedule oral VP, to be repeated every 4 weeks
GEM+DOC:intravenous GEM day1,8 and DOC day8, 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.relapsee osteosarcoma 2.relapse or progression following disease-specific standard chemotherapies 3. evidence of progression or stable disease on imaging studies 4.aged 60 or less 5. no prior chemotherapy containing either Gemcitabine, Docetaxel or temozolomide 6.ECOG Performance Status of 0-2 7.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]) 8. > 14 days since prior other antitumor cytotoxic agents 9.> 21 days since prior non-palliative chest irradiation or 14 days since prior not palliative radiation therapy 10.Not diagnosed as interstitial pneumonia, pulmonary emphysema nor pulmonary fibrosis with chest CT finding 11. > 7 days since prior surgery (including open biopsy) 12. Written informed consent
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 in pregnant, possibly pregnant or breast feeding 6.Psychiatric disease 7.Inadequate physical condition judged by investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free Survival | — |
Secondary
| Measure | Time frame |
|---|---|
| response rate Overall Survival Adverse events profile | — |
Countries
Japan
Contacts
Public ContactAko Hosono
National Cancer Center Hospital East Pediatric Oncology Division
Outcome results
None listed