Ignite Creation Date:
2024-05-04 @ 6:49 PM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002704
Status:
COMPLETED
Last Update Posted:
2013-02-01
First Post:
1999-11-01
Brief Title:
Radiation Therapy and Chemotherapy in Treating Children With CNS Relapse From Acute Lymphoblastic Leukemia
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
TREATMENT OF ISOLATED CNS RELAPSE OF ACUTE LYMPHOBLASTIC LEUKEMIA -- A PEDIATRIC ONCOLOGY GROUP-WIDE PHASE II STUDY
Status:
COMPLETED
Status Verified Date:
2007-11
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:
Phase II trial to study the effectiveness of radiation therapy following chemotherapy in treating children with CNS relapse from acute lymphoblastic leukemia Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die Combining chemotherapy with radiation therapy may kill more cancer cells
Detailed Description:
OBJECTIVES
I Determine the efficacy and toxicity of intensified systemic treatment with delayed central nervous system CNS irradiation in children with acute lymphoblastic leukemia and isolated CNS disease
II Determine the efficacy of systemic thiotepa in reducing or clearing blasts in the cerebrospinal fluid of these patients
III Evaluate the toxicity of single dose thiotepa followed by dexamethasone vincristine daunorubicin and triple intrathecal therapy in these patients
IV Determine the response rate of intrathecal sustained release cytarabine DTC101 in patients with first bone marrow remission with first isolated CNS relapse
V Assess the safety and toxicity of DTC101 in these patients
OUTLINE
Patients with significant neurologic symptoms eg seizures cranial nerve palsy paresis mental status changes are entered directly on the Induction regimen and do not receive the Therapeutic Window The following acronyms are used ARA-C Cytarabine NSC-63878 ASP Asparaginase NSC-109229 E coli or 106977 Erwinia CF Leucovorin calcium NSC-3590 CTX Cyclophosphamide NSC-26271 DM Dexamethasone NSC-34521 DNR Daunorubicin NSC-82151 DTC101 Sustained release cytarabine G-CSF Granulocyte Colony-Stimulating Factor Amgen NSC-614629 HC Hydrocortisone NSC-10483 Mesna Mercaptoethane sulfonate NSC-113891 MP Mercaptopurine NSC-755 MTX Methotrexate NSC-740 TIT Triple Intrathecal Therapy IT MTXIT HCIT ARA-C TMP-SMX Trimethoprim-sulfamethoxazole TSPA Thiotepa NSC-6396 VCR Vincristine NSC-67574 VP-16 Etoposide NSC-141540
THERAPEUTIC WINDOW Single Agent Chemotherapy TSPA or DTC101 Thiotepa window closed as of 7698 DTC101 window opened 111599
INDUCTION 3-Drug Combination Chemotherapy plus Triple Intrathecal Therapy DMDNRVCR plus TIT
CONSOLIDATION 2-Drug Combination Chemotherapy plus Triple Intrathecal Therapy ARA-CASP plus TIT
INTENSIFICATION I 4-Drug Combination Chemotherapy with Leucovorin Rescue plus Triple Intrathecal Therapy CTXMPMTXVP-16 with CF plus TIT
RE-INDUCTION 3-Drug Combination Chemotherapy plus Triple Intrathecal Therapy DMDNRVCR plus TIT
INTENSIFICATION II 6-Drug Combination Chemotherapy with Leucovorin Rescue plus Triple Intrathecal Therapy ARA-CASPCTXMPMTXVP-16 with CF plus TIT
CHEMORADIOTHERAPY Radiotherapy plus 3-Drug Combination Chemotherapy Craniospinal irradiation using x-rays with energies of 4-6 MV electrons acceptable for spinal cord irradiation plus ASPDMVCR
MAINTENANCE 2-Drug Combination Chemotherapy Alternating with 2-Drug Combination Chemotherapy MPMTX alternating with CTXVCR
I Determine the efficacy and toxicity of intensified systemic treatment with delayed central nervous system CNS irradiation in children with acute lymphoblastic leukemia and isolated CNS disease
II Determine the efficacy of systemic thiotepa in reducing or clearing blasts in the cerebrospinal fluid of these patients
III Evaluate the toxicity of single dose thiotepa followed by dexamethasone vincristine daunorubicin and triple intrathecal therapy in these patients
IV Determine the response rate of intrathecal sustained release cytarabine DTC101 in patients with first bone marrow remission with first isolated CNS relapse
V Assess the safety and toxicity of DTC101 in these patients
OUTLINE
Patients with significant neurologic symptoms eg seizures cranial nerve palsy paresis mental status changes are entered directly on the Induction regimen and do not receive the Therapeutic Window The following acronyms are used ARA-C Cytarabine NSC-63878 ASP Asparaginase NSC-109229 E coli or 106977 Erwinia CF Leucovorin calcium NSC-3590 CTX Cyclophosphamide NSC-26271 DM Dexamethasone NSC-34521 DNR Daunorubicin NSC-82151 DTC101 Sustained release cytarabine G-CSF Granulocyte Colony-Stimulating Factor Amgen NSC-614629 HC Hydrocortisone NSC-10483 Mesna Mercaptoethane sulfonate NSC-113891 MP Mercaptopurine NSC-755 MTX Methotrexate NSC-740 TIT Triple Intrathecal Therapy IT MTXIT HCIT ARA-C TMP-SMX Trimethoprim-sulfamethoxazole TSPA Thiotepa NSC-6396 VCR Vincristine NSC-67574 VP-16 Etoposide NSC-141540
THERAPEUTIC WINDOW Single Agent Chemotherapy TSPA or DTC101 Thiotepa window closed as of 7698 DTC101 window opened 111599
INDUCTION 3-Drug Combination Chemotherapy plus Triple Intrathecal Therapy DMDNRVCR plus TIT
CONSOLIDATION 2-Drug Combination Chemotherapy plus Triple Intrathecal Therapy ARA-CASP plus TIT
INTENSIFICATION I 4-Drug Combination Chemotherapy with Leucovorin Rescue plus Triple Intrathecal Therapy CTXMPMTXVP-16 with CF plus TIT
RE-INDUCTION 3-Drug Combination Chemotherapy plus Triple Intrathecal Therapy DMDNRVCR plus TIT
INTENSIFICATION II 6-Drug Combination Chemotherapy with Leucovorin Rescue plus Triple Intrathecal Therapy ARA-CASPCTXMPMTXVP-16 with CF plus TIT
CHEMORADIOTHERAPY Radiotherapy plus 3-Drug Combination Chemotherapy Craniospinal irradiation using x-rays with energies of 4-6 MV electrons acceptable for spinal cord irradiation plus ASPDMVCR
MAINTENANCE 2-Drug Combination Chemotherapy Alternating with 2-Drug Combination Chemotherapy MPMTX alternating with CTXVCR
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 |
|---|---|---|---|
| CDR0000064509 | REGISTRY | PDQ Physician Data Query | None |
| POG-9412 | None | None | None |