Ignite Creation Date:
2024-05-05 @ 10:01 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002494
Status:
COMPLETED
Last Update Posted:
2016-07-04
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy in Treating Patients With Non-Hodgkins Lymphoma or Acute Lymphocytic Leukemia
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
HIGH INTENSITY BRIEF DURATION CHEMOTHERAPY FOR DIFFUSE SMALL NONCLEAVED CELL LYMPHOMA AND THE L-3 SUBTYPE OF ALL A PILOT STUDY OF A MULTIDRUG REGIMEN
Status:
COMPLETED
Status Verified Date:
2016-06
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 cancer cells from dividing so they stop growing or die Combining more than one drug may kill more cancer cells
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy and alternating regimens of chemotherapy in treating patients who have non-Hodgkins lymphoma or acute lymphocytic leukemia
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy and alternating regimens of chemotherapy in treating patients who have non-Hodgkins lymphoma or acute lymphocytic leukemia
Detailed Description:
OBJECTIVES I Determine the response rate and disease free survival of HIV seronegative patients with diffuse small noncleaved cell lymphoma or L3 acute lymphocytic leukemia when treated with high intensity brief duration combination chemotherapy alternating courses of ifosfamidecytarabineetoposide and cyclophosphamidedoxorubicin each with methotrexatevincristinedexamethasone II Determine the toxicity of these regimens in HIV negative patients
OUTLINE Patients are stratified by participating institution and disease type diffuse small noncleaved cell lymphoma vs L3 ALL Patients receive cyclophosphamide IV over 5-10 minutes on days 1 through 5 and oral prednisone on days 1 through 7 followed by alternating courses of 2 ifosfamide IV over 1 hour on days 8 through 12 methotrexate IV over 24 hours on day 8 leucovorin calcium IV over 36 hours after initiation of methotrexate then IV or orally as tolerated after the first 24 hours every 6 hours until the serum methotrexate level is below 5 x 10 to the minus eighth M vincristine IV on day 8 cytarabine IV over 48 hours and etoposide IV over 60 minutes on days 11 and 12 and oral dexamethasone on days 8 through 12 plus triple intrathecal therapy TIT with methotrexate cytarabine and hydrocortisone on days 8 and 12 and 3 cyclophosphamide IV over 5-10 minutes on days 29 through 33 methotrexate IV over 24 hours and vincristine IV on day 29 leucovorin calcium IV over 36 hours after initiation of methotrexate then IV or orally as tolerated after the first 24 hours every 6 hours until the serum methotrexate level is below 5 x 10 to the minus eighth M doxorubicin IV on days 32 and 33 and oral dexamethasone on days 29 through 33 plus TIT on day 29 with doses as above Patients with CNS disease at diagnosis continue TIT once weekly until the CSF clears then weekly for 4 more weeks TIT must be completed prior to initiation of radiotherapy All patients must complete at least the first 3 courses of chemotherapy Courses 2 and 3 each repeat 3 times in the absence of disease progression or unacceptable toxicity On days 134-139 patients who have had prior bone marrow involvement receive cranial radiation therapy Patients who achieve less than a complete response and who have an HLA-matched sibling should undergo allogeneic bone marrow transplant on protocol CLB-9113 Patients are followed monthly for 6 months every 2 months for 18 months every 6 months for 2 years and thereafter for survival
OUTLINE Patients are stratified by participating institution and disease type diffuse small noncleaved cell lymphoma vs L3 ALL Patients receive cyclophosphamide IV over 5-10 minutes on days 1 through 5 and oral prednisone on days 1 through 7 followed by alternating courses of 2 ifosfamide IV over 1 hour on days 8 through 12 methotrexate IV over 24 hours on day 8 leucovorin calcium IV over 36 hours after initiation of methotrexate then IV or orally as tolerated after the first 24 hours every 6 hours until the serum methotrexate level is below 5 x 10 to the minus eighth M vincristine IV on day 8 cytarabine IV over 48 hours and etoposide IV over 60 minutes on days 11 and 12 and oral dexamethasone on days 8 through 12 plus triple intrathecal therapy TIT with methotrexate cytarabine and hydrocortisone on days 8 and 12 and 3 cyclophosphamide IV over 5-10 minutes on days 29 through 33 methotrexate IV over 24 hours and vincristine IV on day 29 leucovorin calcium IV over 36 hours after initiation of methotrexate then IV or orally as tolerated after the first 24 hours every 6 hours until the serum methotrexate level is below 5 x 10 to the minus eighth M doxorubicin IV on days 32 and 33 and oral dexamethasone on days 29 through 33 plus TIT on day 29 with doses as above Patients with CNS disease at diagnosis continue TIT once weekly until the CSF clears then weekly for 4 more weeks TIT must be completed prior to initiation of radiotherapy All patients must complete at least the first 3 courses of chemotherapy Courses 2 and 3 each repeat 3 times in the absence of disease progression or unacceptable toxicity On days 134-139 patients who have had prior bone marrow involvement receive cranial radiation therapy Patients who achieve less than a complete response and who have an HLA-matched sibling should undergo allogeneic bone marrow transplant on protocol CLB-9113 Patients are followed monthly for 6 months every 2 months for 18 months every 6 months for 2 years and thereafter for survival
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 |
|---|---|---|---|
| CDR0000077643 | REGISTRY | NCI Physician Data Query | httpsreporternihgovquickSearchU10CA031946 |
| U10CA031946 | NIH | None | None |
| CLB-9251 | None | None | None |