Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003667
Status:
COMPLETED
Last Update Posted:
2013-06-25
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy and Biological Therapy in Treating Patients With High-Risk Ewings Sarcoma
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
Randomized Phase II Study of Vincristine Doxorubicin Cyclophosphamide and Dexrazoxane With and Without ImmTher for Newly Diagnosed High Risk Ewings Sarcoma
Status:
COMPLETED
Status Verified Date:
2013-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing Combining chemotherapy with biological therapy may kill more tumor cells
PURPOSE Randomized phase II trial to study the effectiveness of combination chemotherapy with or without biological therapy in treating patients who have newly diagnosed high-risk Ewings sarcoma
PURPOSE Randomized phase II trial to study the effectiveness of combination chemotherapy with or without biological therapy in treating patients who have newly diagnosed high-risk Ewings sarcoma
Detailed Description:
OBJECTIVES I Compare the effects of dose intensive regimens of vincristine doxorubicin cyclophosphamide and dexrazoxane with or without ImmTher a muramyl dipeptide liposome on the 2 year disease-free survival of patients with newly diagnosed high risk Ewings sarcoma II Evaluate the feasibility and determine the toxicity of administering weekly ImmTher for 1 year to these patients III Determine which therapy is worthy of further evaluation
OUTLINE This is a randomized study Patients are stratified according to the presence of bony metastases at diagnosis Patients are randomized to one of two treatment arms All patients receive dexrazoxane IV followed 30 minutes later by doxorubicin IV over 30 minutes on day 1 vincristine IV on day 1 and cyclophosphamide IV over 6 hours on days 1 and 2 Treatment is repeated every 3 weeks for 3-6 courses in the absence of disease progression or unacceptable toxicity Patients are evaluated after course 3 and undergo surgery andor radiation therapy The next 3 courses of chemotherapy are administered after recovery from surgeryradiation therapy Within 1 month after completion of all chemotherapy courses patients randomized to arm I receive ImmTher IV over 60 minutes weekly for 1 year Patients randomized to arm II receive no further therapy Patients are followed every 6 weeks for 2 years
PROJECTED ACCRUAL A total of 105 patients will be accrued for this study within approximately 5 years
OUTLINE This is a randomized study Patients are stratified according to the presence of bony metastases at diagnosis Patients are randomized to one of two treatment arms All patients receive dexrazoxane IV followed 30 minutes later by doxorubicin IV over 30 minutes on day 1 vincristine IV on day 1 and cyclophosphamide IV over 6 hours on days 1 and 2 Treatment is repeated every 3 weeks for 3-6 courses in the absence of disease progression or unacceptable toxicity Patients are evaluated after course 3 and undergo surgery andor radiation therapy The next 3 courses of chemotherapy are administered after recovery from surgeryradiation therapy Within 1 month after completion of all chemotherapy courses patients randomized to arm I receive ImmTher IV over 60 minutes weekly for 1 year Patients randomized to arm II receive no further therapy Patients are followed every 6 weeks for 2 years
PROJECTED ACCRUAL A total of 105 patients will be accrued for this study within approximately 5 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-G98-1487 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000066764 | REGISTRY | None | None |
| ENDOREX-MSKCC-98074 | None | None | None |
| MDA-ID-97198 | None | None | None |