Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002610
Status:
COMPLETED
Last Update Posted:
2014-07-25
First Post:
1999-11-01
Brief Title:
Chemotherapy With or Without Surgery Radiation Therapy or Stem Cell Transplantation in Treating Young Patients With Kidney Tumors
Sponsor:
Childrens Oncology Group
Organization:
Childrens Oncology Group
Study Overview
Official Title:
National Wilms Tumor Study-5 -- Treatment of Relapsed Patients A National Wilms Tumor Study Group Phase III Study
Status:
COMPLETED
Status Verified Date:
2014-07
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 Radiation therapy uses high-energy x-rays to damage tumor cells Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells It is not yet known which therapy regimen is most effective for treating patients with kidney tumors
PURPOSE Phase III trial to compare the effectiveness of chemotherapy with or without radiation therapy surgery andor peripheral stem cell or bone marrow transplantation in treating young patients with kidney tumors
PURPOSE Phase III trial to compare the effectiveness of chemotherapy with or without radiation therapy surgery andor peripheral stem cell or bone marrow transplantation in treating young patients with kidney tumors
Detailed Description:
OBJECTIVES
Determine the 2-year second-event-free survival after vincristine VCR and dactinomycin DACT with or without doxorubicin DOX depending on the site of relapse and presence of microscopic residual disease in children with relapsed Wilms tumor previously treated with nephrectomy alone as initial therapy
Determine whether the 2-year second-event-free survival after intensive doxorubicin etoposide VP-16 cyclophosphamide CTX and carboplatin CBDCA plus radiotherapy to residual disease is at least 40 higher in patients with relapsed Wilms tumor previously treated with Regimen EE-4A as initial therapy and without loss of heterozygosity for chromosomes 16q and 1p and increased DNA content in tumor cells than for similarly treated patients with loss of heterozygosity for chromosome 16q or 1p or increased DNA content in tumor cells
Determine whether the 4-year post-relapse survival after intensive VP-16 CTX and CBDCA is at least 40 higher in patients with relapsed Wilms tumor previously treated with Regimen DD-4A as initial therapy and without loss of heterozygosity for chromosomes 16q and 1p and increased DNA content in tumor cells than for similarly treated patients with loss of heterozygosity for chromosome 16q or 1p or increased DNA content in tumor cells
Determine whether the rates of complete and partial response exceed 20 in patients with relapsed clear cell sarcoma of the kidney or diffuse anaplastic Wilms tumor treated with CBDCA combined with VP-16
OUTLINE This is a multicenter study
Patients are assigned to a treatment group based on initial therapy and histology Patients under age 2 at diagnosis who were previously treated with nephrectomy as initial therapy for stage I favorable histology Wilms tumor weighing less than 550 grams are assigned to group A Patients who received Regimen EE-4A as initial therapy for Wilms tumor are assigned to group B Patients who received Regimen DD-4A as initial therapy for Wilms tumor are assigned to group C Patients with clear cell sarcoma of the kidney or diffuse anaplastic Wilms tumor are assigned to group D
Group A
Treatment is determined by site of relapse and the presence of microscopic or gross residual disease after attempted resection of relapsed disease Children with suspected intra-abdominal recurrence undergo exploratory surgery to determine the site of recurrence and to obtain tissue for microscopic examination Patients with stage I disease after recurrence are treated with regimen EE-4A Patients with stage II or III disease are treated with regimen DD-4A
Regimen EE-4A Patients receive dactinomycin DACT IV on weeks 0 3 6 9 12 15 and 18 and vincristine VCR IV on weeks 1-10 12 15 and 18 in the absence of disease progression
Regimen DD-4A Patients receive DACT IV on weeks 0 6 12 18 and 24 VCR IV weekly on weeks 1-10 12 15 18 21 and 24 doxorubicin DOX IV on weeks 3 9 15 and 21 and abdominal radiotherapy in the absence of disease progression
Group B
Patients undergo resection After resection patients receive regimen I comprising DOX IV on weeks 0 6 12 18 and 24 VCR IV on weeks 1 2 4 5-8 10-13 18 and 24 cyclophosphamide CTX IV over 1 hour on days 1-3 of weeks 6 12 18 and 24 and on days 1-5 of weeks 3 9 15 and 21 and etoposide VP-16 IV over 1 hour after CTX infusion on days 1-5 of weeks 3 9 15 and 21 in the absence of disease progression Filgrastim G-CSF is administered subcutaneously SC beginning 24 hours after completion of chemotherapy and continuing until blood counts recover Patients undergo radiotherapy to site of recurrence beginning within 1 week after initiation of chemotherapy
Group C
Induction Patients receive CTX IV over 1 hour on days 1-5 of weeks 0 and 3 VP-16 IV over 1 hour after CTX infusion on days 1-5 of weeks of 0 and 3 and on days 1-3 of weeks 6 and 9 and carboplatin CBDCA IV over 6 hours on days 1 and 2 of weeks 6 and 9 in the absence of disease progression G-CSF is administered SC beginning 24 hours after completion of CTXVP-16 or CBDCAVP-16 and continuing until blood counts recover
Surgery Patients with detectable disease undergo resection on week 13 If complete resection is not achieved or if it is deemed impossible resection must be attempted no later than 3 weeks after consolidation radiotherapy
Consolidation Beginning within 9 days of surgery patients receive CTX IV over 1 hour on days 1-5 of week 1 VP-16 IV over 1 hour after CTX infusion on days 1-5 of week 1 and on days 1-3 of week 4 CBDCA IV over 6 hours on days 1 and 2 of week 4 G-CSF as in induction and radiotherapy in the absence of disease progression Patients with complete or partial response after resection andor radiotherapy proceed to maintenance therapy
Maintenance Patients receive CTX IV over 1 hour on days 1-5 of weeks 0 and 3 VP-16 IV over 1 hour on days 1-5 of weeks 0 and 3 and on days 1-3 of weeks 6 and 9 CBDCA IV over 6 hours on days 1 and 2 of weeks 6 and 9 and G-CSF as in induction Treatment continues every 12 weeks for 6 courses in the absence of disease progression
Group D
Patients receive CBDCA IV over 6 hours on days 1 and 2 and VP-16 IV over 1 hour after CBDCA infusion on days 1-3 of weeks 0 and 3 Treatment continues weekly for 6 courses in the absence of disease progression
Patients are followed every 3 months for 15 months every 6 months for 1 year and then annually for 3 years
PROJECTED ACCRUAL Not specified
Determine the 2-year second-event-free survival after vincristine VCR and dactinomycin DACT with or without doxorubicin DOX depending on the site of relapse and presence of microscopic residual disease in children with relapsed Wilms tumor previously treated with nephrectomy alone as initial therapy
Determine whether the 2-year second-event-free survival after intensive doxorubicin etoposide VP-16 cyclophosphamide CTX and carboplatin CBDCA plus radiotherapy to residual disease is at least 40 higher in patients with relapsed Wilms tumor previously treated with Regimen EE-4A as initial therapy and without loss of heterozygosity for chromosomes 16q and 1p and increased DNA content in tumor cells than for similarly treated patients with loss of heterozygosity for chromosome 16q or 1p or increased DNA content in tumor cells
Determine whether the 4-year post-relapse survival after intensive VP-16 CTX and CBDCA is at least 40 higher in patients with relapsed Wilms tumor previously treated with Regimen DD-4A as initial therapy and without loss of heterozygosity for chromosomes 16q and 1p and increased DNA content in tumor cells than for similarly treated patients with loss of heterozygosity for chromosome 16q or 1p or increased DNA content in tumor cells
Determine whether the rates of complete and partial response exceed 20 in patients with relapsed clear cell sarcoma of the kidney or diffuse anaplastic Wilms tumor treated with CBDCA combined with VP-16
OUTLINE This is a multicenter study
Patients are assigned to a treatment group based on initial therapy and histology Patients under age 2 at diagnosis who were previously treated with nephrectomy as initial therapy for stage I favorable histology Wilms tumor weighing less than 550 grams are assigned to group A Patients who received Regimen EE-4A as initial therapy for Wilms tumor are assigned to group B Patients who received Regimen DD-4A as initial therapy for Wilms tumor are assigned to group C Patients with clear cell sarcoma of the kidney or diffuse anaplastic Wilms tumor are assigned to group D
Group A
Treatment is determined by site of relapse and the presence of microscopic or gross residual disease after attempted resection of relapsed disease Children with suspected intra-abdominal recurrence undergo exploratory surgery to determine the site of recurrence and to obtain tissue for microscopic examination Patients with stage I disease after recurrence are treated with regimen EE-4A Patients with stage II or III disease are treated with regimen DD-4A
Regimen EE-4A Patients receive dactinomycin DACT IV on weeks 0 3 6 9 12 15 and 18 and vincristine VCR IV on weeks 1-10 12 15 and 18 in the absence of disease progression
Regimen DD-4A Patients receive DACT IV on weeks 0 6 12 18 and 24 VCR IV weekly on weeks 1-10 12 15 18 21 and 24 doxorubicin DOX IV on weeks 3 9 15 and 21 and abdominal radiotherapy in the absence of disease progression
Group B
Patients undergo resection After resection patients receive regimen I comprising DOX IV on weeks 0 6 12 18 and 24 VCR IV on weeks 1 2 4 5-8 10-13 18 and 24 cyclophosphamide CTX IV over 1 hour on days 1-3 of weeks 6 12 18 and 24 and on days 1-5 of weeks 3 9 15 and 21 and etoposide VP-16 IV over 1 hour after CTX infusion on days 1-5 of weeks 3 9 15 and 21 in the absence of disease progression Filgrastim G-CSF is administered subcutaneously SC beginning 24 hours after completion of chemotherapy and continuing until blood counts recover Patients undergo radiotherapy to site of recurrence beginning within 1 week after initiation of chemotherapy
Group C
Induction Patients receive CTX IV over 1 hour on days 1-5 of weeks 0 and 3 VP-16 IV over 1 hour after CTX infusion on days 1-5 of weeks of 0 and 3 and on days 1-3 of weeks 6 and 9 and carboplatin CBDCA IV over 6 hours on days 1 and 2 of weeks 6 and 9 in the absence of disease progression G-CSF is administered SC beginning 24 hours after completion of CTXVP-16 or CBDCAVP-16 and continuing until blood counts recover
Surgery Patients with detectable disease undergo resection on week 13 If complete resection is not achieved or if it is deemed impossible resection must be attempted no later than 3 weeks after consolidation radiotherapy
Consolidation Beginning within 9 days of surgery patients receive CTX IV over 1 hour on days 1-5 of week 1 VP-16 IV over 1 hour after CTX infusion on days 1-5 of week 1 and on days 1-3 of week 4 CBDCA IV over 6 hours on days 1 and 2 of week 4 G-CSF as in induction and radiotherapy in the absence of disease progression Patients with complete or partial response after resection andor radiotherapy proceed to maintenance therapy
Maintenance Patients receive CTX IV over 1 hour on days 1-5 of weeks 0 and 3 VP-16 IV over 1 hour on days 1-5 of weeks 0 and 3 and on days 1-3 of weeks 6 and 9 CBDCA IV over 6 hours on days 1 and 2 of weeks 6 and 9 and G-CSF as in induction Treatment continues every 12 weeks for 6 courses in the absence of disease progression
Group D
Patients receive CBDCA IV over 6 hours on days 1 and 2 and VP-16 IV over 1 hour after CBDCA infusion on days 1-3 of weeks 0 and 3 Treatment continues weekly for 6 courses in the absence of disease progression
Patients are followed every 3 months for 15 months every 6 months for 1 year and then annually for 3 years
PROJECTED ACCRUAL Not specified
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 |
|---|---|---|---|
| COG-Q9402 | OTHER | None | None |
| NWTS-Q9402 | OTHER | None | None |
| CCG-4942 | OTHER | None | None |
| POG-9444 | OTHER | None | None |
| INT-0152 | None | None | None |
| NWTS-5R | OTHER | None | None |
| CDR0000063900 | OTHER | NCI | None |