Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002691
Status:
COMPLETED
Last Update Posted:
2013-06-25
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy in Treating Pediatric Patients With Stage III or IV Non-Hodgkins Lymphoma
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
LSA5 PROTOCOL FOR THE TREATMENT OF ADVANCED PEDIATRIC AND ADOLESCENT NON-HODGKINS LYMPHOMA NHL
Status:
COMPLETED
Status Verified Date:
2013-06
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 and using drugs in different ways may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy in treating pediatric patients with stage III or stage IV non-Hodgkins lymphoma
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy in treating pediatric patients with stage III or stage IV non-Hodgkins lymphoma
Detailed Description:
OBJECTIVES I Assess the feasibility of treating all histologic subgroups of pediatric non-Hodgkins lymphoma on one protocol with the addition of asparaginase during the induction and consolidation phases for diffuse lymphoblastic lymphoma and T-cell large noncleaved cell diffuse lymphoma II Assess whether intensification of cyclophosphamide during induction therapy will achieve a complete response rate of 95 in 1 to 15 months for all histologies III Assess whether achieving remission induction in 1 month administering cytarabinemethotrexate by continuous infusion during consolidation therapy and increasing the number of intrathecal methotrexate injections throughout protocol therapy decreases central nervous system relapse in these patients IV Assess whether a 5-year recurrence-free survival of 85 is achievable for all histologies on this protocol V Assess whether duration of maintenance chemotherapy may be stratified by stage and histology of disease to avoid unnecessarily prolonged chemotherapy
OUTLINE The following acronyms are used ARA-C Cytarabine NSC-63878 ASP Asparaginase NSC-109229 CF Leucovorin NSC-3590 CTX Cyclophosphamide NSC-26271 DM Dexamethasone NSC-34521 DNR Daunorubicin NSC-82151 G-CSF Granulocyte Colony-Stimulating Factor NSC-614629 LBL Lymphoblastic Lymphoma LCALKi1B Large Cell Anaplastic B-cell Lymphoma LCALKi1T Large Cell Anaplastic T-cell Lymphoma LCL Large Cell Lymphoma Mesna Mercaptoethane Sulfonate NSC-113891 MTX Methotrexate NSC-740 TMP-SMX Trimethoprim-Sulfamethoxazole VCR Vincristine NSC-67574 VP-16 Etoposide NSC-141540 Induction 2-Drug Combination Systemic Chemotherapy plus Single-Agent Intrathecal Chemotherapy followed by 2- or 3-Drug Combination Systemic Chemotherapy plus Single-Agent Intrathecal Chemotherapy Part I CTXDNR plus IT ARA-C followed by Part II DMVCR plus ASP for patients with LBL T-cell LCL or LCALKi1T plus IT MTX Consolidation 2- or 3-Drug Combination Systemic Chemotherapy with Leucovorin Rescue followed by 2- or 3-Drug Combination Systemic Chemotherapy Part I ARA-CMTX with CF plus ASP for patients with LBL T-cell LCL or LCALKi1T followed by Part II ARA-CVP-16 plus for patients with LBL T-cell LCL or LCALKi1T Maintenance Single-Agent Systemic Chemotherapy with Leucovorin Rescue plus Single-Agent Intrathecal Chemotherapy followed sequentially by 3 2-Drug Combination Systemic Chemotherapy Regimens Part I MTX with CF plus IT MTX followed by Part II CTXVCR followed by Part III ARA-CVP-16 followed by Part IV DNRDM
PROJECTED ACCRUAL 25 patientsstratum are expected to be accrued over 3 years This study will be reviewed for early closure if more than 1 patient has PD
OUTLINE The following acronyms are used ARA-C Cytarabine NSC-63878 ASP Asparaginase NSC-109229 CF Leucovorin NSC-3590 CTX Cyclophosphamide NSC-26271 DM Dexamethasone NSC-34521 DNR Daunorubicin NSC-82151 G-CSF Granulocyte Colony-Stimulating Factor NSC-614629 LBL Lymphoblastic Lymphoma LCALKi1B Large Cell Anaplastic B-cell Lymphoma LCALKi1T Large Cell Anaplastic T-cell Lymphoma LCL Large Cell Lymphoma Mesna Mercaptoethane Sulfonate NSC-113891 MTX Methotrexate NSC-740 TMP-SMX Trimethoprim-Sulfamethoxazole VCR Vincristine NSC-67574 VP-16 Etoposide NSC-141540 Induction 2-Drug Combination Systemic Chemotherapy plus Single-Agent Intrathecal Chemotherapy followed by 2- or 3-Drug Combination Systemic Chemotherapy plus Single-Agent Intrathecal Chemotherapy Part I CTXDNR plus IT ARA-C followed by Part II DMVCR plus ASP for patients with LBL T-cell LCL or LCALKi1T plus IT MTX Consolidation 2- or 3-Drug Combination Systemic Chemotherapy with Leucovorin Rescue followed by 2- or 3-Drug Combination Systemic Chemotherapy Part I ARA-CMTX with CF plus ASP for patients with LBL T-cell LCL or LCALKi1T followed by Part II ARA-CVP-16 plus for patients with LBL T-cell LCL or LCALKi1T Maintenance Single-Agent Systemic Chemotherapy with Leucovorin Rescue plus Single-Agent Intrathecal Chemotherapy followed sequentially by 3 2-Drug Combination Systemic Chemotherapy Regimens Part I MTX with CF plus IT MTX followed by Part II CTXVCR followed by Part III ARA-CVP-16 followed by Part IV DNRDM
PROJECTED ACCRUAL 25 patientsstratum are expected to be accrued over 3 years This study will be reviewed for early closure if more than 1 patient has PD
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-V95-0763 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000064426 | REGISTRY | None | None |