Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002590
Status:
COMPLETED
Last Update Posted:
2014-07-24
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy in Treating Children With Lymphoma
Sponsor:
Childrens Oncology Group
Organization:
Childrens Oncology Group
Study Overview
Official Title:
A Pilot Study For The Treatment of Newly-Diagnosed Disseminated Anaplastic Large Cell Ki-1 Lymphoma and T-Large Cell Lymphoma
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 Combining more than one drug may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy in treating children who have lymphoma
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy in treating children who have lymphoma
Detailed Description:
OBJECTIVES I Estimate the toxicity and feasibility of intensifying the New York I NYI regimen by adding etoposide and cytarabine increasing the dose of methotrexate using pegaspargase and compressing the treatment duration 11 months in previously untreated children with disseminated anaplastic Ki-1 positive large cell and large cell T-cell lymphoma II Provide preliminary data for a future phase III study that will compare this intensified regimen with the high-risk ALL regimen NYI in children with disseminated lymphoblastic lymphoma III Continue to investigate the immunophenotype cytogenetics and molecular biology of lymphoblastic lymphoma and their relationship to leukemia IV Obtain preliminary data on treatment of anaplastic large cell Ki-1 and T-cell large cell lymphoma treated with intensive NYI
OUTLINE Patients with CNS disease at diagnosis receive craniospinal irradiation on Regimen A at the conclusion of Maintenance chemotherapy The following acronyms are used ARA-C Cytarabine NSC-63878 CF Leucovorin calcium NSC-3590 CTX Cyclophosphamide NSC-26271 DNR Daunorubicin NSC-82151 DOX Doxorubicin NSC-123127 G-CSF Granulocyte Colony-Stimulating Factor Amgen NSC-614629 MTX Methotrexate NSC-740 PEG-ASP Pegaspargase NSC-624239 PRED Prednisone NSC-10023 TG Thioguanine NSC-752 VCR Vincristine NSC-67574 VP-16 Etoposide NSC-141540 Induction 5-Drug Combination Systemic Chemotherapy with Hematopoietic Stimulation plus 2-Drug Combination Intrathecal Chemotherapy VCRPREDCTXDNRPEG-ASP with G-CSF plus IT ARA-CIT MTX Consolidation 7-Drug Combination Systemic Chemotherapy with Hematopoietic Stimulation plus Single-Agent Intrathecal Chemotherapy VCRPREDPEG-ASPVP-16TGARA-CMTXCF with G-CSF plus IT MTX Maintenance Sequential Pulses of 2- 3- 3- and 2-Drug Systemic Chemotherapy Combinations plus Single-Agent Intrathecal Chemotherapy CTXTGIT MTX VCRPREDDOX VCRMTXCFPEG-ASP ARA-CVP-16 Regimen A Radiotherapy Craniospinal irradiation using megavoltage equipment
PROJECTED ACCRUAL 40 patients will be entered over approximately 10 months If 4 or more toxic deaths occur in the first 15 patients or 5 or more toxic deaths occur in the first 30 patients accrual will stop As of 0596 asparaginase has been replaced with pegaspargase 15-25 additional patients will be accrued As of 0197 a maximum of 35 patients will be accrued for PEG asparaginase-containing treatment regimen As of 597 this study is open only to patients with anaplastic large cell and T cell large cell lymphoma Approximately 60-90 patients will be accrued
OUTLINE Patients with CNS disease at diagnosis receive craniospinal irradiation on Regimen A at the conclusion of Maintenance chemotherapy The following acronyms are used ARA-C Cytarabine NSC-63878 CF Leucovorin calcium NSC-3590 CTX Cyclophosphamide NSC-26271 DNR Daunorubicin NSC-82151 DOX Doxorubicin NSC-123127 G-CSF Granulocyte Colony-Stimulating Factor Amgen NSC-614629 MTX Methotrexate NSC-740 PEG-ASP Pegaspargase NSC-624239 PRED Prednisone NSC-10023 TG Thioguanine NSC-752 VCR Vincristine NSC-67574 VP-16 Etoposide NSC-141540 Induction 5-Drug Combination Systemic Chemotherapy with Hematopoietic Stimulation plus 2-Drug Combination Intrathecal Chemotherapy VCRPREDCTXDNRPEG-ASP with G-CSF plus IT ARA-CIT MTX Consolidation 7-Drug Combination Systemic Chemotherapy with Hematopoietic Stimulation plus Single-Agent Intrathecal Chemotherapy VCRPREDPEG-ASPVP-16TGARA-CMTXCF with G-CSF plus IT MTX Maintenance Sequential Pulses of 2- 3- 3- and 2-Drug Systemic Chemotherapy Combinations plus Single-Agent Intrathecal Chemotherapy CTXTGIT MTX VCRPREDDOX VCRMTXCFPEG-ASP ARA-CVP-16 Regimen A Radiotherapy Craniospinal irradiation using megavoltage equipment
PROJECTED ACCRUAL 40 patients will be entered over approximately 10 months If 4 or more toxic deaths occur in the first 15 patients or 5 or more toxic deaths occur in the first 30 patients accrual will stop As of 0596 asparaginase has been replaced with pegaspargase 15-25 additional patients will be accrued As of 0197 a maximum of 35 patients will be accrued for PEG asparaginase-containing treatment regimen As of 597 this study is open only to patients with anaplastic large cell and T cell large cell lymphoma Approximately 60-90 patients will be accrued
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 |
|---|---|---|---|
| CDR0000063751 | OTHER | NCI | None |
| CCG-5941 | OTHER | None | None |