Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00025103
Status:
UNKNOWN
Last Update Posted:
2013-08-02
First Post:
2001-10-11
Brief Title:
Chemotherapy Followed by Surgery and Radiation Therapy With or Without Stem Cell Transplant in Treating Patients With Relapsed or Refractory Wilms Tumor or Clear Cell Sarcoma of the Kidney
Sponsor:
Childrens Cancer and Leukaemia Group
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Protocol For The Treatment Of Relapsed And Refractory Wilms Tumour And Clear Cell Sarcoma Of The Kidney CCSK
Status:
UNKNOWN
Status Verified Date:
2009-06
Last Known Status:
ACTIVE_NOT_RECRUITING
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 Combining chemotherapy with peripheral stem cell transplant may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells
PURPOSE This phase II trial is studying how well chemotherapy followed by surgery and radiation therapy with or without stem cell transplant work in treating patients with relapsed or refractory Wilms tumor or clear cell sarcoma of the kidney
PURPOSE This phase II trial is studying how well chemotherapy followed by surgery and radiation therapy with or without stem cell transplant work in treating patients with relapsed or refractory Wilms tumor or clear cell sarcoma of the kidney
Detailed Description:
OBJECTIVES
Determine survival rates of patients with relapsed or refractory Wilms tumor or clear cell sarcoma of the kidney treated with chemotherapy followed by surgical resection and adjuvant radiotherapy with or without autologous stem cell rescue
Determine the efficacy and toxicity of these regimens in these patients
Determine prognostic variables in patients treated with these regimens
OUTLINE Patients are assigned to one of three treatment regimens
Regimen A patients with initial stage I tumors previously treated with vincristine with or without dactinomycin with relapse at least 6 months after diagnosis Patients receive vincristine IV once weekly on weeks 1-10 and then every 3 weeks during weeks 11-52 dactinomycin IV every 3 weeks during weeks 1-52 and doxorubicin IV over 6 hours every 3 weeks during weeks 1-34 weeks 1-28 if pulmonary radiotherapy is planned Patients undergo surgical resection and radiotherapy after 6 weeks of therapy
Regimen B patients with initial stage II tumors previously treated with vincristine and dactinomycin with relapse at least 6 months after diagnosis Patients receive cyclophosphamide IV twice daily on days 1-2 and 22-23 etoposide IV over 1 hour on days 1-3 and doxorubicin IV over 6 hours on days 22 and 23 Treatment repeats every 42 days for a total of 4 courses Patients undergo surgical resection and radiotherapy after 2 courses of chemotherapy Patients not achieving complete response after 4 courses of chemotherapy undergo autologous bone marrow transplantation as in regimen C
Regimen C all other patients in first relapses OR with progression on first-line therapy OR in second or subsequent relapse previously treated on regimens A and B Patients receive carboplatin IV over 1 hour on day 1 etoposide IV over 2 hours on days 1-3 and 22-24 and cyclophosphamide IV twice daily on days 22 and 23 Treatment repeats every 42 days for a total of 3 courses Patients may undergo surgical resection prior to stem cell rescue Beginning within 6 weeks after completion of chemotherapy patients receive melphalan IV on day -1 Autologous peripheral blood stem cells or bone marrow is reinfused on day 0 Patients undergo radiotherapy after transplantation
Patients are followed every 8 weeks for 1 year every 12 weeks for 1 year and then every 6 months thereafter
PROJECTED ACCRUAL Approximately 75 patients 25 for regimens A and B and 50 for regimen C will be accrued for this study
Determine survival rates of patients with relapsed or refractory Wilms tumor or clear cell sarcoma of the kidney treated with chemotherapy followed by surgical resection and adjuvant radiotherapy with or without autologous stem cell rescue
Determine the efficacy and toxicity of these regimens in these patients
Determine prognostic variables in patients treated with these regimens
OUTLINE Patients are assigned to one of three treatment regimens
Regimen A patients with initial stage I tumors previously treated with vincristine with or without dactinomycin with relapse at least 6 months after diagnosis Patients receive vincristine IV once weekly on weeks 1-10 and then every 3 weeks during weeks 11-52 dactinomycin IV every 3 weeks during weeks 1-52 and doxorubicin IV over 6 hours every 3 weeks during weeks 1-34 weeks 1-28 if pulmonary radiotherapy is planned Patients undergo surgical resection and radiotherapy after 6 weeks of therapy
Regimen B patients with initial stage II tumors previously treated with vincristine and dactinomycin with relapse at least 6 months after diagnosis Patients receive cyclophosphamide IV twice daily on days 1-2 and 22-23 etoposide IV over 1 hour on days 1-3 and doxorubicin IV over 6 hours on days 22 and 23 Treatment repeats every 42 days for a total of 4 courses Patients undergo surgical resection and radiotherapy after 2 courses of chemotherapy Patients not achieving complete response after 4 courses of chemotherapy undergo autologous bone marrow transplantation as in regimen C
Regimen C all other patients in first relapses OR with progression on first-line therapy OR in second or subsequent relapse previously treated on regimens A and B Patients receive carboplatin IV over 1 hour on day 1 etoposide IV over 2 hours on days 1-3 and 22-24 and cyclophosphamide IV twice daily on days 22 and 23 Treatment repeats every 42 days for a total of 3 courses Patients may undergo surgical resection prior to stem cell rescue Beginning within 6 weeks after completion of chemotherapy patients receive melphalan IV on day -1 Autologous peripheral blood stem cells or bone marrow is reinfused on day 0 Patients undergo radiotherapy after transplantation
Patients are followed every 8 weeks for 1 year every 12 weeks for 1 year and then every 6 months thereafter
PROJECTED ACCRUAL Approximately 75 patients 25 for regimens A and B and 50 for regimen C will be accrued for this study
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000068913 | REGISTRY | None | None |
| EU-20127 | Registry Identifier | PDQ Physician Data Query | None |