Relapse/ refractory pediatric and adolescent and young adult cancer
Conditions
Interventions
gefitinib and irinotecan regimen in which gefitinib 112.5mg/m2/day p.o. on days 1-12, irinotecan 30mg/m2 DIV over 30 min on days 1-5, and cefixime 8mg/kg/day p.o. on days -1-14 on to be repeated every
Sponsors
Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital pediatric division/musculoskeltal oncology division/ neurology division
NPO SUCCESS Support Center for Therapeutic Development
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. neuroblastoma, retinoblastoma, rhabdomyosarcoma, undifferentiated sarcoma, Ewing's sarcoma family of tumor, osteosarcoma, glioma, meduloblastoma, germ cell tumor 2. relapse or progression following disease specific first-line standard chemotherapies 3. no prior use of irinotecan, gefitinib, erlotinib, or cetuximab 4. evidence of progression in clinical signs or symptoms or on imaging studies 5. > 14 days since prior antitumor cytotoxic agents except nitrosourea and > 28 days since prior nitrosourea 6. >= 14 days for local palliative radiation and > 6 months must have elapsed if prior craniospinal XRT or if >= 50% radiation of pelvis and >= 8 weeks must have elapsed if conventional radiation for brain tumor and >= 6 weeks must have elapsed if other substantial BM radiation 7. > 14 days since prior surgery (containing open biopsy) 8. 0-2 in ECOG PS 9. no findings of interstitial pneumonia on CT 11. no signs or symptoms equivalent to CTC-AE Grade2 diarrhea 12. 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 >= 75,000/mm~3 (platelet transfusions allowed) (3) serum total Bilirubin <= 1.2mg/dl (4) ALT <= 100 IU/l (5) 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]) 13. legal adult: Written informed consent 14. 16 years and over, but, no legal adult: written informed consent from both patient and legal guardian 15. 15 years and under: written informed consent from legal guardian
Exclusion criteria
Exclusion criteria: 1. >4 weeks since prior CYP3A4 inducer uptake 2. >1 week since prior CYP3A4 inhibitor uptake 3. 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 4. Active infection requiring systemic medication 5. abnormality in electrocardiogram tested within 28 days, requiring intervention 6. respiratory or heart disorder requiring oxygen supply, except from malignant pleural effusion 7. Women during pregnancy or breast-feeding 8. Psychosis 9. Systemic steroids or immunosuppressants medication except for continuous steroid use for increased intracranial pressure and/or brain edema
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| incidence of dose limiting toxicity | — |
Secondary
| Measure | Time frame |
|---|---|
| incidence of adverse event, pharmacokinetic parameter, feasibility of concurrent administration of gefitinib and irinotecan | — |
Countries
Japan
Contacts
Public ContactHiroshi Kawamoto
Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital pediatric division/ clinical reserch division
Outcome results
None listed