Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00038142
Status:
TERMINATED
Last Update Posted:
2020-01-29
First Post:
2002-05-29
Brief Title:
Vincristine Doxorubicin Cyclophosphamide and Dexrazoxane VACdxr in High Risk Ewings Sarcoma Patients
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Randomized Phase II Study of Vincristine Doxorubicin Cyclophosphamide and Dexrazoxane VACdxr With or Without ImmTher for Newly Diagnosed High Risk Ewings Sarcoma
Status:
TERMINATED
Status Verified Date:
2020-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Low Accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Objectives
1 To determine if dose intensive Vincristine Doxorubicin Cyclophosphamide and Dexrazoxane VACdxr with or without ImmTherTM can improve the 2-year disease-free survival seen with standard VAC therapy
2 To evaluate the feasibility and describe the toxicity associated with VACdxr
3 To evaluate the feasibility and describe the toxicity of administering ImmTherTM on a weekly basis for 50- 52 weeks
4 To determine which therapy VACdxr or VACdxr- is worthy of further evaluation
1 To determine if dose intensive Vincristine Doxorubicin Cyclophosphamide and Dexrazoxane VACdxr with or without ImmTherTM can improve the 2-year disease-free survival seen with standard VAC therapy
2 To evaluate the feasibility and describe the toxicity associated with VACdxr
3 To evaluate the feasibility and describe the toxicity of administering ImmTherTM on a weekly basis for 50- 52 weeks
4 To determine which therapy VACdxr or VACdxr- is worthy of further evaluation
Detailed Description:
Patients will be assigned at random as by the toss of a coin to receive 1 of 2 treatments
Arm A VACdxr will be given over 2 days through a needle in a vein On day 1 vincristine will be given over 15 minutes and doxorubicin will be given over 30 minutes
Dexrazoxane will be given 30 minutes before doxorubicin this drug protects the heart from damage by doxorubicin Cyclophosphamide will be given once a day on days 1 and 2 This will make up 1 cycle of VACdxr treatment the cycle will be repeated every 3 weeks for up to 6 cycles
To prevent some side effects of VACdxr the drugs Mesna and Neupogenor Neulasta will also be given Mesna helps prevent bladder damage Neupogen is a growth factor that stimulates the body to make more white blood cells Neulasta is a growth factor related to Neupogen
After cycle 3 surgery may be done to remove any tumor that remains The principal investigator will also decide whether radiation treatment should be done If so patients will receive radiation therapy
Starting 1 month after all treatment is done patients will receive ImmTher ImmTher stimulates the bodys white blood cells to attack and kill tumor cells The drug will be given through a needle in a vein over 1 hour every week for 1 year
Arm B Patients will be treated the same as patients in Arm A except that they will not receive ImmTher
Patients may have to stay in the hospital during VACdxr treatment and after surgery Patients will receive ImmTher in the outpatient clinic
Before treatment starts patients will have a complete exam including blood and urine tests and an EKG and ECHO or multiple gated acquisition scan MUGA heart function tests X-rays and CT MRI bone marrow aspiration and bone scans will be done Women will have a pregnancy test
After each treatment with drugs after surgery and after radiation treatment patients will have checkups These will include blood and urine tests and sometimes x-rays
After cycle 3 of VACdxr patients will have chest x-ray and x-ray of primary tumor CT chest MRI bone marrow aspiration and bone scans will be done after 3 cycles as indicated These tests will be done to record and measure tumors
After treatment stops patients will return for checkups every 3 months for 2 years
This is an investigational study ImmTher is an investigational agent All other study drugs are approved by the US Food and Drug Administration As many as 104 patients will take part in the study about 95 of these will be treated at MD Anderson
Arm A VACdxr will be given over 2 days through a needle in a vein On day 1 vincristine will be given over 15 minutes and doxorubicin will be given over 30 minutes
Dexrazoxane will be given 30 minutes before doxorubicin this drug protects the heart from damage by doxorubicin Cyclophosphamide will be given once a day on days 1 and 2 This will make up 1 cycle of VACdxr treatment the cycle will be repeated every 3 weeks for up to 6 cycles
To prevent some side effects of VACdxr the drugs Mesna and Neupogenor Neulasta will also be given Mesna helps prevent bladder damage Neupogen is a growth factor that stimulates the body to make more white blood cells Neulasta is a growth factor related to Neupogen
After cycle 3 surgery may be done to remove any tumor that remains The principal investigator will also decide whether radiation treatment should be done If so patients will receive radiation therapy
Starting 1 month after all treatment is done patients will receive ImmTher ImmTher stimulates the bodys white blood cells to attack and kill tumor cells The drug will be given through a needle in a vein over 1 hour every week for 1 year
Arm B Patients will be treated the same as patients in Arm A except that they will not receive ImmTher
Patients may have to stay in the hospital during VACdxr treatment and after surgery Patients will receive ImmTher in the outpatient clinic
Before treatment starts patients will have a complete exam including blood and urine tests and an EKG and ECHO or multiple gated acquisition scan MUGA heart function tests X-rays and CT MRI bone marrow aspiration and bone scans will be done Women will have a pregnancy test
After each treatment with drugs after surgery and after radiation treatment patients will have checkups These will include blood and urine tests and sometimes x-rays
After cycle 3 of VACdxr patients will have chest x-ray and x-ray of primary tumor CT chest MRI bone marrow aspiration and bone scans will be done after 3 cycles as indicated These tests will be done to record and measure tumors
After treatment stops patients will return for checkups every 3 months for 2 years
This is an investigational study ImmTher is an investigational agent All other study drugs are approved by the US Food and Drug Administration As many as 104 patients will take part in the study about 95 of these will be treated at MD Anderson
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-2012-01285 | REGISTRY | NCI CTRP | None |