Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002802
Status:
COMPLETED
Last Update Posted:
2013-12-19
First Post:
1999-11-01
Brief Title:
Therapy Based on Stage of Disease and Risk Assessment in Treating Children With Neuroblastoma
Sponsor:
Childrens Hospital Medical Center Cincinnati
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
PHASE III MULTICENTRE TRIAL OF TREATMENT OF NEUROBLASTOMA IN CHILDREN AND ADOLESCENTS
Status:
COMPLETED
Status Verified Date:
2007-05
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 Combining chemotherapy with bone marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells Radiation therapy uses high-energy x-rays to damage tumor cells It is not yet known which treatment regimen is most effective in treating patients with different stages of and risk factors for neuroblastoma
PURPOSE Phase III trial to study the effectiveness of therapy based on stage of disease and risk assessment in treating children with neuroblastoma
PURPOSE Phase III trial to study the effectiveness of therapy based on stage of disease and risk assessment in treating children with neuroblastoma
Detailed Description:
OBJECTIVES I Increase the survival rates and duration of survival in children and adolescents with neuroblastoma by using stage- and risk group-appropriate therapy II Determine whether using cisplatinetoposidevindesine and vincristinedacarbazineifosfamidedoxorubicin instead of cisplatinteniposide and vincristinedacarbazinecyclophosphamidedoxorubicin improves remission rate and lessens toxicity in patients with stage 3C 3D or 4 neuroblastoma III Determine whether local radiotherapy to the primary tumor and bone metastasis improves local tumor control in these patients IV Compare the efficacy and survival associated with short-term high-dose conditioning chemotherapy plus autologous bone marrow transplantation vs long-term low-dose cytostatic chemotherapy as consolidation therapy in these patients V Determine whether early use of low-dose doxorubicinvincristine plus hepatic irradiation slows disease progression in patients with stage 4S-C neuroblastoma VI Determine whether 4 courses of chemotherapy reduces the occurrence of local and systemic relapse in patients with stages 2 3A and 3B neuroblastoma VII Determine whether serum tumor markers LDH catecholamine metabolites and neuron-specific enolase are predictive of remission behavior
OUTLINE Patients are staged according to the International Neuroblastoma Staging System and are further defined by progressively less favorable risk groups based on age at diagnosis serum LDH and tumor resectability risk groups A B C and D representing presence of 0 1 2 or 3 risk factors respectively Patients who are unable to be resected at entry or with incomplete resection are re-evaluated at 4-month intervals for the appropriateness of tumor resection STAGE 1 PATIENTS Patients undergo complete primary tumor resection and no other therapy STAGES 2 3A AND 3B PATIENTS Patients undergo primary tumor resection followed by cisplatin etoposide vindesine PEV alternating monthly with vincristine dacarbazine ifosfamide doxorubicin VDIA Patients in complete remission CR discontinue therapy while those with less than CR receive additional therapy as outlined below for stages 3C 3D and 4 patients except that these patients are not eligible for bone marrow transplantation STAGES 3C 3D AND 4 PATIENTS Patients receive PEV and VDIA as above with radiotherapy to sites of metastases during the third and fourth courses following which autologous bone marrow is collected Following marrow harvest patients receive up to 4 more alternating courses of PEVVDIA those with no response or progressive disease after the sixth chemotherapy course are referred for other therapy Patients who complete PEVVDIA receive 3 weeks of radiotherapy to the primary tumor bed or residual tumor Stage 4 patients in complete or very good partial remission and with sufficient harvested marrow undergo ABMT following radiotherapy Myeloablation consists of high-dose MIBG radioisotope therapy followed by high-dose melphalan etoposide and carboplatin All other patients and those who refuse ABMT receive 1 year of alternating low-dose chemotherapy courses beginning concurrently with initiation of radiotherapy One regimen consists of oral melphalanetoposide for 5 days and the other regimen consists of intravenous vincristine on 1 day and oral cyclophosphamide for 7 days Therapy continues for 1 year STAGE 4S PATIENTS Patients in risk groups 4S-A and 4S-B receive no therapy Patients in group 4S-C receive 4-8 weekly injections of doxorubicin and vincristine AV Patients with tumor progression may receive low-dose radiotherapy Primary tumor resection may be delayed up to 8 months after diagnosis in these patients Use of G-CSF is allowed but not recommended
PROJECTED ACCRUAL Approximately 500 patients will be accrued on this multicenter study
OUTLINE Patients are staged according to the International Neuroblastoma Staging System and are further defined by progressively less favorable risk groups based on age at diagnosis serum LDH and tumor resectability risk groups A B C and D representing presence of 0 1 2 or 3 risk factors respectively Patients who are unable to be resected at entry or with incomplete resection are re-evaluated at 4-month intervals for the appropriateness of tumor resection STAGE 1 PATIENTS Patients undergo complete primary tumor resection and no other therapy STAGES 2 3A AND 3B PATIENTS Patients undergo primary tumor resection followed by cisplatin etoposide vindesine PEV alternating monthly with vincristine dacarbazine ifosfamide doxorubicin VDIA Patients in complete remission CR discontinue therapy while those with less than CR receive additional therapy as outlined below for stages 3C 3D and 4 patients except that these patients are not eligible for bone marrow transplantation STAGES 3C 3D AND 4 PATIENTS Patients receive PEV and VDIA as above with radiotherapy to sites of metastases during the third and fourth courses following which autologous bone marrow is collected Following marrow harvest patients receive up to 4 more alternating courses of PEVVDIA those with no response or progressive disease after the sixth chemotherapy course are referred for other therapy Patients who complete PEVVDIA receive 3 weeks of radiotherapy to the primary tumor bed or residual tumor Stage 4 patients in complete or very good partial remission and with sufficient harvested marrow undergo ABMT following radiotherapy Myeloablation consists of high-dose MIBG radioisotope therapy followed by high-dose melphalan etoposide and carboplatin All other patients and those who refuse ABMT receive 1 year of alternating low-dose chemotherapy courses beginning concurrently with initiation of radiotherapy One regimen consists of oral melphalanetoposide for 5 days and the other regimen consists of intravenous vincristine on 1 day and oral cyclophosphamide for 7 days Therapy continues for 1 year STAGE 4S PATIENTS Patients in risk groups 4S-A and 4S-B receive no therapy Patients in group 4S-C receive 4-8 weekly injections of doxorubicin and vincristine AV Patients with tumor progression may receive low-dose radiotherapy Primary tumor resection may be delayed up to 8 months after diagnosis in these patients Use of G-CSF is allowed but not recommended
PROJECTED ACCRUAL Approximately 500 patients will be accrued on this multicenter study
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 |
|---|---|---|---|
| EU-96004 | None | None | None |
| GER-NB90 | None | None | None |