Ewing's sarcoma Cancer Malignant neoplasm of bone and articular cartilage of other and unspecified sites
Conditions
Interventions
Non-randomised phase II study of oral treosulfan in advanced pre-treated Ewing's sarcoma. Treosulfan 1 g/m^2 will be administered in three divided doses, daily over 7 days and repeated every 28 days,
Sponsors
University College London (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 29/11/2011: 1. Age less than 50 years, either sex 2. Histologically proven Ewing's sarcoma/peripheral neuroectodermal tumour 3. Patients with advanced, refractory disease who have failed at least one course of conventional chemotherapy and for whom no curative option exists 4. Measurable disease, defined by Response Evaluation Criteria in Solid Tumors (RECIST) 5. Evidence of disease progression within the preceding 8 weeks 6. Neutrophils greater than or equal to 1.5 x 10^9/l and platelet count greater than or equal to 100 x 10^9/l 7. Creatinine less than or equal to 1.5 x upper limit of normal (ULN) 8. Serum bilirubin and aspartate aminotransferase (AST)/alanine aminotransferase (ALT) less than or equal to 1.5 x ULN 9. Performance status 0-2 (patients 16 years or older) or Lansky Performance Status greater than 30 (patients under 16 years). (n.b. patients with WHO performance status 3 due to spinal disease will be eligible provided they are otherwise medically well) 10. Patient able to comply with protocol treatment (swallow capsules) and follow up 11. Life expectancy of three months or greater 12. Written informed consent of patient or parent/legal guardian Previous inclusion criteria: 9. World Health Organization (WHO) performance status greater than 3 (patients greater than 16 years); or Lansky Performance Status greater than 30
Exclusion criteria
Exclusion criteria: 1. Newly diagnosed, or resectable Ewing's sarcoma 2. Pregnant/lactating women, or women of childbearing potential unless using effective contraception 3. Concurrent treatment with any other anti-cancer therapy, except palliative radiotherapy to non-target lesions 4. Concurrent treatment with other experimental drugs 5. Concurrent treatment with growth factors
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcomes measure as of 29/11/2011: Objective response rate achieved: tumour response will be measured as defined by the RECIST guidelines. Previous primary outcome measure: Objective response rate achieved: tumour response will be measured as defined by the RECIST guidelines. Following analysis of data for initial 15 patients, if the measured success is less than or equal to 10% then the study will be stopped. Otherwise, the study will close once a total of 25 eligible patients have been enrolled. | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 29/11/2011: 1. Event-free survival 2. Overall survival 3. Toxicity : if there is more than one toxic death, or more than two unexpected treatment related serious adverse events occurring in two separate individuals, an Independent Data Monitoring Committee meeting will take place and advice sought regarding continuing the trial 4. Duration of response 5. Time to progression/relapse Previous secondary outcome measures: 1. Toxicity: if there is more than one toxic death, or more than two unexpected serious adverse events occurring in two separate individuals, the chief/co-investigators will consider stopping the trial 2. Duration of response 3. Time to progression 4. Correlation of deoxyribonucleic acid (DNA) cross-linking and retention with response and toxicity | — |
Countries
England, United Kingdom
Outcome results
None listed